This document discusses project management approaches for medical publication writing projects. It begins by describing the typical structure of a publication writing team within a pharmaceutical company or clinical research organization. It then proposes applying the five process groups of the Project Management Body of Knowledge (PMBOK) framework to manage publication writing projects: initiation, planning, execution, monitoring and control, and closing. Key aspects of each stage are discussed, including developing a publication plan, defining project specifications, assigning roles and resources, creating timelines and workflows, drafting and reviewing publications, and addressing comments. Project management aims to expedite publication projects while ensuring seamless delivery and quality.
A Translational Medicine Platform at SanofiMongoDB
Sanofi is using MongoDB as a central data repository to support its translational medicine platform by enabling researchers to store, organize, collaborate on, link, visualize, and analyze omics data, clinical records, and other research information in order to more efficiently conduct clinical trials and develop personalized medicines. The MongoDB implementation provides benefits like reduced development time, improved data quality and understanding for scientists, and increased flexibility and performance for IT.
Regulatory medical writing is an integral part of Medical Communications, but is often overlooked. In simple terms, it involves writing of the documents required for the approval of drugs by the regulatory authorities.
https://www.cognibrain.com/regulatory-medical-writing/
Views for collaboration between pharmaceutical industry and academia a haapal...Antti Haapalinna
The document discusses views on collaboration between the pharmaceutical industry and academia from Antti Haapalinna, Vice President of Research and Development at Orion Corporation. It notes that strategic partnerships can cover the entire R&D chain from early discovery to late-stage clinical development and marketing. Early-stage partnerships are often with smaller organizations that provide specific expertise to complement larger companies. Later-stage partnerships are usually with larger organizations for their clinical trial expertise and global reach. Key success factors include a mutual desire to develop new treatments, each party contributing unique capabilities, and professionally coordinated collaboration.
This document discusses medical writing, including its definition, types, need, required skills, duties of medical writers, and medical writing organizations. Medical writing involves producing scientific documentation for research performed by doctors and scientists. It emerged in the pharmaceutical industry due to the specialized skills needed to clearly present complex clinical trial information. The two main types are regulatory medical writing for approval documents, and educational writing for general audiences. Medical writing is needed due to the complexity of research and trials. Key skills include attention to detail, strong writing abilities, and scientific knowledge. Medical writers prepare documents for regulatory submissions and publications, and work to ensure clear communication of information. Several organizations support medical writers internationally.
Regulatory documents are required by health authorities before approval of new drugs, devices, or biologics. These documents include protocols, clinical study reports, investigator brochures, common technical documents, informed consent forms, and risk management plans. Protocols describe the study procedures and analysis plans. Clinical study reports integrate full study reports according to ICH guidelines. Investigator brochures provide safety information to investigators. Common technical documents assemble quality, safety, and efficacy data for regulatory submissions. Informed consent forms provide study information for participants. Risk management plans describe safety profiles and risk minimization plans.
This document provides an overview of the key responsibilities of sponsors and contract research organizations (CROs) in clinical trials. It discusses CRO responsibilities in areas such as regulatory affairs, project management, clinical operations, biometrics, medical writing, pharmacovigilance, and quality assurance. For each area, it briefly outlines some of the main tasks involved, such as regulatory submission and approval, clinical monitoring, statistical analysis, safety reporting, and ensuring compliance with Good Clinical Practice standards. The overall purpose is to define the roles that CROs take on to assist sponsors in managing various aspects of clinical research.
Designing of clinical study protocol rumana hameedRumana Hameed
This document provides guidance on designing clinical study documents, including protocols and case report forms (CRFs). It discusses key components of trial master files, protocols, and their amendments. Protocols should include background information, objectives, design, endpoints, inclusion/exclusion criteria, and plans for statistical analysis and publication. CRFs are important trial documents used to collect patient data uniformly. Their design should follow guidelines, with clear instructions and formatting. Errors in CRFs should be addressed through queries. Overall, the document outlines best practices for developing the main documents used to conduct clinical trials and collect trial data.
Bradycardia Global Clinical Trials Review, H1, 2013ReportLinker.com
Bradycardia Global Clinical Trials Review, H1, 2013
Summary
GlobalData's clinical trial report, 'Bradycardia Global Clinical Trials Review, H1, 2013" provides data on the Bradycardia clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Bradycardia. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Bradycardia. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.
Scope
- Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type- Listings of discontinued trials (suspended, withdrawn and terminated)
Reasons to buy
- Understand the dynamics of a particular indication in a condensed manner- Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more- Obtain discontinued trial listing for trials across the globe- Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies
A Translational Medicine Platform at SanofiMongoDB
Sanofi is using MongoDB as a central data repository to support its translational medicine platform by enabling researchers to store, organize, collaborate on, link, visualize, and analyze omics data, clinical records, and other research information in order to more efficiently conduct clinical trials and develop personalized medicines. The MongoDB implementation provides benefits like reduced development time, improved data quality and understanding for scientists, and increased flexibility and performance for IT.
Regulatory medical writing is an integral part of Medical Communications, but is often overlooked. In simple terms, it involves writing of the documents required for the approval of drugs by the regulatory authorities.
https://www.cognibrain.com/regulatory-medical-writing/
Views for collaboration between pharmaceutical industry and academia a haapal...Antti Haapalinna
The document discusses views on collaboration between the pharmaceutical industry and academia from Antti Haapalinna, Vice President of Research and Development at Orion Corporation. It notes that strategic partnerships can cover the entire R&D chain from early discovery to late-stage clinical development and marketing. Early-stage partnerships are often with smaller organizations that provide specific expertise to complement larger companies. Later-stage partnerships are usually with larger organizations for their clinical trial expertise and global reach. Key success factors include a mutual desire to develop new treatments, each party contributing unique capabilities, and professionally coordinated collaboration.
This document discusses medical writing, including its definition, types, need, required skills, duties of medical writers, and medical writing organizations. Medical writing involves producing scientific documentation for research performed by doctors and scientists. It emerged in the pharmaceutical industry due to the specialized skills needed to clearly present complex clinical trial information. The two main types are regulatory medical writing for approval documents, and educational writing for general audiences. Medical writing is needed due to the complexity of research and trials. Key skills include attention to detail, strong writing abilities, and scientific knowledge. Medical writers prepare documents for regulatory submissions and publications, and work to ensure clear communication of information. Several organizations support medical writers internationally.
Regulatory documents are required by health authorities before approval of new drugs, devices, or biologics. These documents include protocols, clinical study reports, investigator brochures, common technical documents, informed consent forms, and risk management plans. Protocols describe the study procedures and analysis plans. Clinical study reports integrate full study reports according to ICH guidelines. Investigator brochures provide safety information to investigators. Common technical documents assemble quality, safety, and efficacy data for regulatory submissions. Informed consent forms provide study information for participants. Risk management plans describe safety profiles and risk minimization plans.
This document provides an overview of the key responsibilities of sponsors and contract research organizations (CROs) in clinical trials. It discusses CRO responsibilities in areas such as regulatory affairs, project management, clinical operations, biometrics, medical writing, pharmacovigilance, and quality assurance. For each area, it briefly outlines some of the main tasks involved, such as regulatory submission and approval, clinical monitoring, statistical analysis, safety reporting, and ensuring compliance with Good Clinical Practice standards. The overall purpose is to define the roles that CROs take on to assist sponsors in managing various aspects of clinical research.
Designing of clinical study protocol rumana hameedRumana Hameed
This document provides guidance on designing clinical study documents, including protocols and case report forms (CRFs). It discusses key components of trial master files, protocols, and their amendments. Protocols should include background information, objectives, design, endpoints, inclusion/exclusion criteria, and plans for statistical analysis and publication. CRFs are important trial documents used to collect patient data uniformly. Their design should follow guidelines, with clear instructions and formatting. Errors in CRFs should be addressed through queries. Overall, the document outlines best practices for developing the main documents used to conduct clinical trials and collect trial data.
Bradycardia Global Clinical Trials Review, H1, 2013ReportLinker.com
Bradycardia Global Clinical Trials Review, H1, 2013
Summary
GlobalData's clinical trial report, 'Bradycardia Global Clinical Trials Review, H1, 2013" provides data on the Bradycardia clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Bradycardia. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Bradycardia. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.
Scope
- Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type- Listings of discontinued trials (suspended, withdrawn and terminated)
Reasons to buy
- Understand the dynamics of a particular indication in a condensed manner- Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more- Obtain discontinued trial listing for trials across the globe- Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies
Informed consent documents are required to explain clinical trials to participants and obtain their signed agreement to participate. They must include the study purpose, procedures, risks/benefits, alternatives to participation, and participant rights. Case report forms are used to record all required study data for each participant and facilitate data collection, management, and analysis while protecting privacy. The investigator's brochure provides investigators details on the investigational product and guidance for the study based on nonclinical and clinical data.
This document discusses Contract Research Organizations (CROs) and their role in supporting pharmaceutical clinical trials. It provides the following key points:
- CROs are service organizations that conduct clinical trials and other drug development work on behalf of pharmaceutical companies. They help companies that lack sufficient resources or expertise to conduct all required trials themselves.
- Selecting the right CRO is important for a successful clinical trial. Sponsors should clearly define study specifications, evaluate a CRO's capabilities and compatibility, and consider cost. Ongoing management of the sponsor-CRO relationship also impacts success.
- Common issues like selecting an inappropriate CRO, unclear study specifications from the sponsor, or poor management can lead
Chemometrics Pharmacometrics Econometrics of QbD Swiss Pharma-6 2012Ajaz Hussain
The document discusses the potential role of mathematical modeling tools in improving regulatory communications on quality by design in the pharmaceutical industry. Specifically, it argues that chemometrics, pharmacometrics, and econometrics can provide objective ways to integrate scientific data across the product lifecycle in order to facilitate more risk-based regulatory decisions. Development reports that utilize chemometrics to predict critical quality attributes and verify predictions, along with explanations connecting these attributes to clinical outcomes, can give regulators a means to evaluate scientific understanding. Econometric modeling of manufacturing practices and their impact on product variability may allow facilities to be categorized by risk level. This integrated approach using multiple disciplines can help realize the goals of quality by design.
Steps For Designing And Development Of Protocolpviral24
This document outlines the key sections and information to include when designing a clinical trial protocol. It discusses including background information on the investigational product, objectives, study design details, subject selection criteria, safety and efficacy assessments, data collection and management plans, statistical analysis methods, and other operational aspects like financing, publications, and records retention. The protocol is the detailed research plan that clinical trials are based on and it describes the rationale, structure, and procedures for the study.
This document provides an introduction to clinical trials. It defines a clinical trial as a research study performed on human subjects to determine if a new drug or therapy is both safe and effective. The document outlines the different phases of clinical trials, from pre-clinical testing on animals to post-market surveillance. It describes key terms used in clinical trials and explains the various stakeholders who are involved in and care about clinical trials, such as those in clinical development, business development, marketing, and information professionals. Finally, it discusses some of the main challenges of clinical trials, including demonstrating efficacy and safety, differentiating treatments, and getting regulatory approval.
The NRC, as a part of an effort to establish a water trail on the Nisqually River, conducted a survey to understand public opinions towards such a trail.
Virtual assistants provide a time efficient, cost effective solution for small businesses as an alternative to in-office employees. They work remotely through internet and phone, allowing businesses to avoid overhead costs of office space, equipment and benefits. On average, virtual assistants cost a business around half the total cost of an in-office employee. Polaris Administrative Concepts offers various virtual assistant services including information processing, desktop publishing and secretarial work, with competitive prices and proven performance.
Elite screens are available from Dukane.
Dukane is an American company serving the education, corporate, government and house of worship markets for over 85 years.
For more information contact:
Delia Valdez
Dukane Customer Service Representative
Phone: 800-076-2485
Fax: (630) 584-5156
Email: AVSales@Dukane.com
Website: www.Dukane.com/AV
For information on Dukane’s Innovative Convey Response system, go to
www.conveyclassrooms.com
Dukane AV
2900 Dukane Drive
St. Charles, IL 60174
This document describes content discovery features in PubMed that aim to provide related information from other NCBI databases based on a user's search terms. It discusses sensors, database advertisements, and generic discovery aids that appear in search results or in abstract displays to direct users to connected data. Sensors like citation, accession number, gene, drug, and hot topic sensors link to related records. Database advertisements promote records from structures, sequences, and clinical trials. Generic aids include auto-suggest, "find related data" links, and descriptions of linked resources. The goal is serendipitous discovery by drawing connections between PubMed and other NCBI databases.
Este documento describe un proyecto para gestionar pasivos ambientales en áreas protegidas de Bolivia influenciadas por actividades mineras e hidrocarburíferas. El proyecto tiene tres resultados: 1) Actualizar información sobre sitios extractivos abandonados y su impacto en 10 áreas protegidas; 2) Diseñar políticas y estrategias para gestionar pasivos ambientales en estas áreas y minimizar futuros impactos; y 3) Generar conocimientos para mejorar la gestión de pasivos a nivel institucional, social y académico. El proyecto
Bisleri is an Italian-founded Indian mineral water company with 60% of the packaged water market in India. It sources its mountain water from natural springs located in the Himalayan and Shivalik mountain ranges. In addition to its core mineral water, Bisleri offers mountain water and recently launched a fizzy soda water. While Kinley, Aquafina, and local brands comprise the remaining 40% of the market, Bisleri has established itself as the leading water brand through innovative products and a focus on advertising and hygiene.
This document is a cover letter and resume submitted by Devandrin Pillay for a job vacancy. The cover letter introduces Pillay as a self-motivated individual with experience in customer support and people management. The resume provides details of Pillay's personal information, qualifications, skills and 20 years of work experience in operations management, warehouse control, and administration roles for various logistics and recruitment companies. Pillay is seeking new opportunities to contribute their knowledge and experience.
The document provides location scouting information for several scenes in a short film about teenagers. It describes the alleyway of Bush Close as a suitable quiet location to film a conversation scene. The car park of Netley Road is recommended for its size, seclusion and staircase, making it well-suited for a fight and death scene. The document also proposes using the author's bedroom and bathroom for indoor scenes due to their convenient access and features that fit the mood of different scenes.
Este documento describe las plataformas de multimedia y cómo se pueden clasificar. Explica que la multimedia consiste en el uso de diversos medios como audio, video e imágenes para transmitir información. Las plataformas multimedia se clasifican en educativas, comerciales, informativas y publicitarias. Cada una se caracteriza por los medios y contenidos que utilizan para transmitir información de manera enriquecida e interactiva.
Modul ini membahas tentang pertumbuhan dan perkembangan anak serta pentingnya bermain bagi anak. Bermain memiliki berbagai fungsi seperti membantu perkembangan sensorik, motorik, kognitif, sosialisasi, kreativitas, dan kesadaran diri anak. Jenis permainan dan karakteristiknya berbeda sesuai dengan usia anak."
The document discusses the marketing strategy of Bisleri bottled water. It describes how Bisleri segmented the market into different package sizes for daily, long-distance, and event consumption. Bisleri targeted cities and urban areas and focused on the middle-to-high income demographic. The company differentiated its products through innovative packaging and sizes, extensive distribution channels, and advertising campaigns emphasizing purity and the mountain source. Through strategic planning and adapting to changes in the market, Bisleri was able to grow its market share significantly over the decades.
INTERNET OF (EVERY)THING & SMART AGRICULTURE 10 Settembre 2015 EXPO, Milano
The interaction between physical objects and sensors connected to Internet makes it possible to exchange information in a manner which has never previously been possible anywhere in the world and to render smart objects inanimate in order to provide functionality and services which have not yet been fully explored.
Internet of (Every)Thing (IoE) entails various levels: from the smart home to the production of goods, among which food, and to the management of natural resources, like water. The IoE can therefore vary from examples of “consumer” oriented interconnected devices to more “enterprise” driven business cases, raising the interest of Governments and public administrations as well.
One of the most interesting field for our State’s future is the “smart agriculture”, monitoring micro- climate parameters supporting agriculture to improve products’ quality, to reduce risks coming from unpredictable weather phenomenon, to rationalize resources and to reduce the environmental impact.
If on one hand the IoE will make the world a better place to live, on the other hand it will be paramount to prevent and impede possible future abuses and violations.
The goal of the meeting is to gather international technical and legal experts to discuss opportunities and risks of IoE world.
http://www.technandlaw.net
The document discusses the FDA's Critical Path Initiative, which aims to improve the process of drug development and evaluation. It notes that the current drug development process is becoming a bottleneck. The initiative seeks to identify specific projects through a science-driven, shared effort between stakeholders to improve efficiency. The FDA must lead efforts to question assumptions that slow new product development and identify more efficient alternatives. The document also discusses two proposed projects - to create a "current state" process map to identify opportunities for improvement, and to develop a knowledge management system using ICH Q8 to ensure appropriate connectivity between all regulatory disciplines involved in drug development and review.
This document provides an overview of medical writing, including:
- Defining medical writing as applying clinical research principles to develop documents that clearly describe research results and medical information.
- Outlining the different types of medical writing such as regulatory, educational, and publication/presentation.
- Explaining that medical writing emerged in the pharmaceutical industry to produce well-structured documents that present complex clinical trial information clearly.
- Detailing the skills required for medical writing like domain knowledge, statistics, writing ability, and understanding guidelines.
Pharmaceutical Technology Transfer Best PracticesAnthony Grenier
Key Takeaways from the Technology Transfer Guidelines
• Standardize checklist for transferring product development, process development, and analytical method development knowledge
• Requirements are summarized in key deliverables and reports
Creating a Comprehensive Drug Development PlanCovance
This white paper provides an overview of creating an integrated drug development plan, overcoming common development challenges and devising strategies that increase the likelihood of delivering a new, approved medicine to patients.
Informed consent documents are required to explain clinical trials to participants and obtain their signed agreement to participate. They must include the study purpose, procedures, risks/benefits, alternatives to participation, and participant rights. Case report forms are used to record all required study data for each participant and facilitate data collection, management, and analysis while protecting privacy. The investigator's brochure provides investigators details on the investigational product and guidance for the study based on nonclinical and clinical data.
This document discusses Contract Research Organizations (CROs) and their role in supporting pharmaceutical clinical trials. It provides the following key points:
- CROs are service organizations that conduct clinical trials and other drug development work on behalf of pharmaceutical companies. They help companies that lack sufficient resources or expertise to conduct all required trials themselves.
- Selecting the right CRO is important for a successful clinical trial. Sponsors should clearly define study specifications, evaluate a CRO's capabilities and compatibility, and consider cost. Ongoing management of the sponsor-CRO relationship also impacts success.
- Common issues like selecting an inappropriate CRO, unclear study specifications from the sponsor, or poor management can lead
Chemometrics Pharmacometrics Econometrics of QbD Swiss Pharma-6 2012Ajaz Hussain
The document discusses the potential role of mathematical modeling tools in improving regulatory communications on quality by design in the pharmaceutical industry. Specifically, it argues that chemometrics, pharmacometrics, and econometrics can provide objective ways to integrate scientific data across the product lifecycle in order to facilitate more risk-based regulatory decisions. Development reports that utilize chemometrics to predict critical quality attributes and verify predictions, along with explanations connecting these attributes to clinical outcomes, can give regulators a means to evaluate scientific understanding. Econometric modeling of manufacturing practices and their impact on product variability may allow facilities to be categorized by risk level. This integrated approach using multiple disciplines can help realize the goals of quality by design.
Steps For Designing And Development Of Protocolpviral24
This document outlines the key sections and information to include when designing a clinical trial protocol. It discusses including background information on the investigational product, objectives, study design details, subject selection criteria, safety and efficacy assessments, data collection and management plans, statistical analysis methods, and other operational aspects like financing, publications, and records retention. The protocol is the detailed research plan that clinical trials are based on and it describes the rationale, structure, and procedures for the study.
This document provides an introduction to clinical trials. It defines a clinical trial as a research study performed on human subjects to determine if a new drug or therapy is both safe and effective. The document outlines the different phases of clinical trials, from pre-clinical testing on animals to post-market surveillance. It describes key terms used in clinical trials and explains the various stakeholders who are involved in and care about clinical trials, such as those in clinical development, business development, marketing, and information professionals. Finally, it discusses some of the main challenges of clinical trials, including demonstrating efficacy and safety, differentiating treatments, and getting regulatory approval.
The NRC, as a part of an effort to establish a water trail on the Nisqually River, conducted a survey to understand public opinions towards such a trail.
Virtual assistants provide a time efficient, cost effective solution for small businesses as an alternative to in-office employees. They work remotely through internet and phone, allowing businesses to avoid overhead costs of office space, equipment and benefits. On average, virtual assistants cost a business around half the total cost of an in-office employee. Polaris Administrative Concepts offers various virtual assistant services including information processing, desktop publishing and secretarial work, with competitive prices and proven performance.
Elite screens are available from Dukane.
Dukane is an American company serving the education, corporate, government and house of worship markets for over 85 years.
For more information contact:
Delia Valdez
Dukane Customer Service Representative
Phone: 800-076-2485
Fax: (630) 584-5156
Email: AVSales@Dukane.com
Website: www.Dukane.com/AV
For information on Dukane’s Innovative Convey Response system, go to
www.conveyclassrooms.com
Dukane AV
2900 Dukane Drive
St. Charles, IL 60174
This document describes content discovery features in PubMed that aim to provide related information from other NCBI databases based on a user's search terms. It discusses sensors, database advertisements, and generic discovery aids that appear in search results or in abstract displays to direct users to connected data. Sensors like citation, accession number, gene, drug, and hot topic sensors link to related records. Database advertisements promote records from structures, sequences, and clinical trials. Generic aids include auto-suggest, "find related data" links, and descriptions of linked resources. The goal is serendipitous discovery by drawing connections between PubMed and other NCBI databases.
Este documento describe un proyecto para gestionar pasivos ambientales en áreas protegidas de Bolivia influenciadas por actividades mineras e hidrocarburíferas. El proyecto tiene tres resultados: 1) Actualizar información sobre sitios extractivos abandonados y su impacto en 10 áreas protegidas; 2) Diseñar políticas y estrategias para gestionar pasivos ambientales en estas áreas y minimizar futuros impactos; y 3) Generar conocimientos para mejorar la gestión de pasivos a nivel institucional, social y académico. El proyecto
Bisleri is an Italian-founded Indian mineral water company with 60% of the packaged water market in India. It sources its mountain water from natural springs located in the Himalayan and Shivalik mountain ranges. In addition to its core mineral water, Bisleri offers mountain water and recently launched a fizzy soda water. While Kinley, Aquafina, and local brands comprise the remaining 40% of the market, Bisleri has established itself as the leading water brand through innovative products and a focus on advertising and hygiene.
This document is a cover letter and resume submitted by Devandrin Pillay for a job vacancy. The cover letter introduces Pillay as a self-motivated individual with experience in customer support and people management. The resume provides details of Pillay's personal information, qualifications, skills and 20 years of work experience in operations management, warehouse control, and administration roles for various logistics and recruitment companies. Pillay is seeking new opportunities to contribute their knowledge and experience.
The document provides location scouting information for several scenes in a short film about teenagers. It describes the alleyway of Bush Close as a suitable quiet location to film a conversation scene. The car park of Netley Road is recommended for its size, seclusion and staircase, making it well-suited for a fight and death scene. The document also proposes using the author's bedroom and bathroom for indoor scenes due to their convenient access and features that fit the mood of different scenes.
Este documento describe las plataformas de multimedia y cómo se pueden clasificar. Explica que la multimedia consiste en el uso de diversos medios como audio, video e imágenes para transmitir información. Las plataformas multimedia se clasifican en educativas, comerciales, informativas y publicitarias. Cada una se caracteriza por los medios y contenidos que utilizan para transmitir información de manera enriquecida e interactiva.
Modul ini membahas tentang pertumbuhan dan perkembangan anak serta pentingnya bermain bagi anak. Bermain memiliki berbagai fungsi seperti membantu perkembangan sensorik, motorik, kognitif, sosialisasi, kreativitas, dan kesadaran diri anak. Jenis permainan dan karakteristiknya berbeda sesuai dengan usia anak."
The document discusses the marketing strategy of Bisleri bottled water. It describes how Bisleri segmented the market into different package sizes for daily, long-distance, and event consumption. Bisleri targeted cities and urban areas and focused on the middle-to-high income demographic. The company differentiated its products through innovative packaging and sizes, extensive distribution channels, and advertising campaigns emphasizing purity and the mountain source. Through strategic planning and adapting to changes in the market, Bisleri was able to grow its market share significantly over the decades.
INTERNET OF (EVERY)THING & SMART AGRICULTURE 10 Settembre 2015 EXPO, Milano
The interaction between physical objects and sensors connected to Internet makes it possible to exchange information in a manner which has never previously been possible anywhere in the world and to render smart objects inanimate in order to provide functionality and services which have not yet been fully explored.
Internet of (Every)Thing (IoE) entails various levels: from the smart home to the production of goods, among which food, and to the management of natural resources, like water. The IoE can therefore vary from examples of “consumer” oriented interconnected devices to more “enterprise” driven business cases, raising the interest of Governments and public administrations as well.
One of the most interesting field for our State’s future is the “smart agriculture”, monitoring micro- climate parameters supporting agriculture to improve products’ quality, to reduce risks coming from unpredictable weather phenomenon, to rationalize resources and to reduce the environmental impact.
If on one hand the IoE will make the world a better place to live, on the other hand it will be paramount to prevent and impede possible future abuses and violations.
The goal of the meeting is to gather international technical and legal experts to discuss opportunities and risks of IoE world.
http://www.technandlaw.net
The document discusses the FDA's Critical Path Initiative, which aims to improve the process of drug development and evaluation. It notes that the current drug development process is becoming a bottleneck. The initiative seeks to identify specific projects through a science-driven, shared effort between stakeholders to improve efficiency. The FDA must lead efforts to question assumptions that slow new product development and identify more efficient alternatives. The document also discusses two proposed projects - to create a "current state" process map to identify opportunities for improvement, and to develop a knowledge management system using ICH Q8 to ensure appropriate connectivity between all regulatory disciplines involved in drug development and review.
This document provides an overview of medical writing, including:
- Defining medical writing as applying clinical research principles to develop documents that clearly describe research results and medical information.
- Outlining the different types of medical writing such as regulatory, educational, and publication/presentation.
- Explaining that medical writing emerged in the pharmaceutical industry to produce well-structured documents that present complex clinical trial information clearly.
- Detailing the skills required for medical writing like domain knowledge, statistics, writing ability, and understanding guidelines.
Pharmaceutical Technology Transfer Best PracticesAnthony Grenier
Key Takeaways from the Technology Transfer Guidelines
• Standardize checklist for transferring product development, process development, and analytical method development knowledge
• Requirements are summarized in key deliverables and reports
Creating a Comprehensive Drug Development PlanCovance
This white paper provides an overview of creating an integrated drug development plan, overcoming common development challenges and devising strategies that increase the likelihood of delivering a new, approved medicine to patients.
This document discusses project management in the pharmaceutical industry. It covers topics such as the importance of planning, types of planning, steps involved in planning, elements of planning, challenges, project implementation, and measuring project success. It also provides a case study on Eli Lilly and how the company overcame challenges through increased R&D spending, collaborations, and implementing open innovation strategies.
D1.2 Review of Policies of Perspectives on Real-World DataAmr Makady
This document provides a review of different stakeholders' policies and perspectives on using real-world data (RWD) for early drug development and clinical effectiveness assessment. Interviews were conducted with 19 stakeholders from 7 groups. In general, policies on RWD collection and use differ between stakeholders due to their different goals. Cultural barriers, a lack of standardization, and ambiguity in policies pose challenges to incorporating RWD. Increased collaboration is needed to develop common understandings and address issues regarding governance, evidence requirements, and research methods.
The document outlines various medical affairs services including:
1. Training medical affairs and medical science liaison teams through assessments, individual development plans, and educational programs covering topics like clinical development and evidence-based medicine.
2. Providing scientific monitoring services such as literature searches, quality appraisal, and activating relevant information through updated materials and training.
3. Developing patient support programs including reminders, education, recommendations, and integrating online and in-person support.
Outsourcing of Regulatory Affairs Tasks in PharmaceuticalAnu Gummerus
The document summarizes a study on the outsourcing of regulatory affairs tasks in the pharmaceutical industry in Europe. The key findings are:
1) The most commonly outsourced regulatory task was translation of product information texts (75% of respondents).
2) The main reason for outsourcing regulatory affairs tasks to Contract Research Organizations (CROs) was the heavy workload in companies' regulatory departments. Ensuring outsourcing is cost-effective was also a key factor.
3) When choosing a CRO partner, companies valued the CRO's experience and knowledge most highly. Personal contacts with the CRO were also often mentioned as important in selecting a partner.
This document summarizes key messages from a report on research, development, and evaluation strategies for pharmaceutical education and the workforce globally. It finds that (1) healthcare demands require scaling up health workforces including pharmaceutical experts, (2) research and evaluation are integral to achieving workforce development goals, and (3) data from 21 countries shows varying progress towards goals but high alignment between national strategies and goals, indicating the goals are measurable and achievable. The document calls for continued global engagement and monitoring to develop pharmaceutical workforces according to needs.
This document introduces the importance of research, development and evaluation strategies for advancing the global pharmaceutical workforce agenda. It discusses how global health organizations are promoting workforce development to achieve universal health coverage and sustainable development goals. It outlines FIP's adoption of a global vision and Pharmaceutical Workforce Development Goals to guide the transformation of the pharmaceutical workforce. The document argues that research, development and evaluation are integral to implementing this agenda and achieving progress on the goals. It provides context on global health strategies and highlights the need for countries to develop aligned national strategies to scale up their pharmaceutical workforces.
This document discusses the importance of project management for drug development. It explains that project management aims to deliver projects on time and on budget by using planning, execution, and closeout processes. It also discusses the need to use both "horizontal" project management processes and "vertical" drug development processes. The "horizontal" processes provide business controls for schedule and budget, while the "vertical" processes define the scientific and regulatory steps to develop and test new drugs. By combining these two types of processes, project managers can help ensure new drugs are successfully developed and delivered to market as planned.
This document presents a systematic literature review of 38 empirical studies on factors relating to successful business intelligence (BI) system implementation. The review identified 10 key factors that frequently influenced implementation success based on their frequency of occurrence in the literature. These factors included management support, data source systems, organizational resources, IT infrastructure, vision, champion, team skills, project manager, user participation, and change management. The study aims to help researchers better identify relevant studies for literature reviews on factors impacting BI system implementation.
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The purpose of this presentation is to describe step by step the transition of a SAS Programmer into a Clinical Statistical Programmer. It can be used as guidelines for SAS Programmers who wants to put their programming and technical expertise into industries.
A SAS Programmer is someone who uses SAS software for different scenarios. The person who uses it for different purposes is known as a SAS Programmer.
On the other hand, a Clinical Statistical Programmer performs all the procedures to generate future outputs and makes advanced and real-world developments to face further challenges. A primary role of Clinical Statistical Programmers is to use their technical and programming skills in order to enable clinical trial statisticians to perform their statistical analysis duties more efficiently.
This presentation will briefly discuss about the smooth transition that a SAS Programmer needs to go through in order to become a Clinical Statistical Programmer.
This document summarizes the findings of a benchmarking report on scientific publication strategies conducted by Best Practices, LLC. It provides an overview of the study methodology and objectives. Key insights from the study include that global peer-reviewed publications are considered the most effective vehicle during phase III trials and post-launch, though their effectiveness has declined since 2007. The benchmarked organizations were split on whether publication plan delivery is centralized or decentralized. Finally, vice presidents most commonly oversee publication functions at the benchmarked organizations.
While the evolution of information technology is bringing the data closer to customers for their own exploration, the need of a comprehensive understanding of the therapeutic area knowledge for programmers in clinical development is increasing. Starting with a basic understanding on the medical background, special assessment methods, ways of statistically analyzing and displaying the data, to name a few essential ones enables programmers to interact with partners (e.g. scientist, statisticians etc.) on equal par.
In this intent, activities to collect and provide comprehensive information around the Oncology and Rheumatoid Arthritis Therapeutic Areas (TA) via the PhUSE Wiki had started in February 2013 and continued throughout the year. Various PhUSE members have spent time and energy to provide and expand their knowledge and make it available to the entire community.
Today, although there is still much to do to complete and maintain the collected material, the two TA Wikis are a useful tool for Statistical Programmers approaching these TA for the first time or who want to improve their knowledge. Moreover the PhUSE Wiki can be seen as a basic tool for future developments to improve the way professionals in the different TA work. An established working relationship across organizations, pharmaceutical companies or external service providers, will help to support implementation of TA-specific standards from mapping raw data in SDTM, data analysis using ADaM and finally data presentation in standardized outputs. The PhUSE Wiki can be the central place to share important updates such as new CDISC TA standards or the availability of new TA regulatory guidance. On the other hand we see the Wiki as a place to discuss, to stimulate and inspire new initiatives among the “SAS-Programming Community”, be it Statisticians, Programmers, Data Managers or everyone else involved; this may include specific TA working related white papers and/or scripts being part of the FDA Working Groups WG5 “Development of Standard Scripts for Analysis and Programming” Project 08 “Create white papers providing recommended display and analysis including Table, List and Figure shells”.
Presented at PhUSE/FDA CSS 2014 in Silver Spring (US)
The document outlines a program in clinical trials, research, and data management consisting of 7 modules. Module I discusses clinical trials and the clinical trials environment. Module II covers statistics for clinical trials. Module III is about clinical data management. Module IV is on contract research. Module V addresses regulatory affairs, good clinical practices, pharmacovigilance, and ethics. Module VI is on practical medical writing and documentation. Module VII provides skills for conducting research studies. The program aims to provide skills for careers in clinical research.
INTRODUCTIONThe increasing discussion about rising healthcare co.docxvrickens
INTRODUCTION
The increasing discussion about rising healthcare cost is fuelled by reports that General Motors paid more for healthcare than for steel per vehicle in 2004,1 and Starbucks paid more for health insurance than for coffee in 2005.2 The continuing rise in development costs for drugs has increased pressure on R&D organisations to contribute to higher efficiency in the overall process of coming up with new drugs.
In the last few years the industry has made significant efforts to address these challenges3 and to increase the productivity of the drug development process. Some of the initiatives have without doubt led to considerable improvements. Examples are the earlier determination of a drug's toxicology profile and early tests to investigate the suitability of a new drug candidate for oral administration or once a day dosing. The question is no longer how good we are in what we are doing but whether we are doing the right things. Further improvements of the overall process should shift from attempts of enhancing effectiveness to a greater emphasis on the efficiency of the processes applied.
In this context a lot of emphasis is put on portfolio management. In the broadest definition, portfolio management describes the process of maximising the value of R&D portfolios through proper resource allocation. This requires an alignment of portfolio management with strategic business objectives. Such objectives should not only be general (e.g., innovation) and quantitative (eg ROI or sales targets). They should also define disease areas of interest, clearly outline the remaining medical needs, and specify the indications that are considered worth pursuing. This will enable decision makers and functional R&D managers to identify projects with both strategic fit and a high value proposition. Depending on the size of the organisation, either a corporate or therapeutic area strategies need to be developed, approved, and endorsed by the entire organisation.
Value-driven project and portfolio management implies quantitative financial and risk analysis of individual projects and overall portfolios. Such analyses elucidate options for improving the value and risk structure of individual projects on the one hand and therapeutic areas or overall corporate portfolios on the other hand. They are applicable and relevant to companies of any size. Value-driven project and portfolio management is a methodology enabling the alignment of project decisions with corporate strategy and defined business objectives.
Although portfolio management has been applied in the financial industry for many years and Harry Markowitz was honoured with the Nobel Prize for outlining this concept it was only around the end of the last century that the application of value-driven portfolio management in the pharmaceutical industry was published. 4 Around the same time, an investigation across various industries provided evidence that portfolio management based on quantitative fin ...
Anjala Sikri has extensive medical writing experience in pharmaceutical companies, clinical research organizations, training centers, publication houses, and international biotechnology groups. She has drafted and edited various clinical trial documents including protocols, informed consent forms, investigators brochures, and clinical study reports. She also has experience writing training materials, standard operating procedures, clinical pharmacology presentations, product marketing documents, and graphical illustrations.
1. 36 | March 2016 Medical Writing | Volume 25 Number 1
Prashant Auti, Rishabh Pandey,
Vatsal Shah
SIRO Clinpharm Private Limited,
Thane (W), India
Project management in medical
publication writing: A less explored
avenue in pharmaceutical companies
and clinical research organisations
Correspondence to:
Prashant Auti,
SIRO Clinpharm Pvt Ltd,
Kalpataru Prime, 1st floor,
Unit Nos. 3 & 4, Plot no. D-3,
Road no. 16, Wagle Industrial Estate,
Thane (W) - 400 604,
Maharashtra, India.
Tel: +91 22 6108 8145
bd@siroclinpharm.com
prashantauti23@gmail.com
2. Project management in medical publication writing – Auti / Pandey / Shah
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 37
Abstract
Drug development forms the core of the
pharmaceutical industry. Medical writing
is a key function in pharmaceutical
companies and clinical research organ-
isations that works on scientific pub-
lications and regulatory dossiers.
Regulatory writing steers the drafting
and submission of regulatory dossiers
and safety reports to health authorities;
medical publication writing on the other
hand deals with scientific publications
such as manuscripts, abstracts, present-
ations, and posters. Project management
is essential for the expedited execution
and seamless delivery of publication
writing projects with a quick turnaround
time. End-to-end project management of
publication writing projects on the lines
of five-stage process of the Project
Management Body of Knowledge
(PMBOK) is discussed in this article.
Introduction
Medical writing is a diverse field originated
from the need of pharmaceutical companies
to have a support function that works
exclusively on regulatory submissions and
commercialscientificcommunications.1This
function is responsible for the analysis,
interpretation,anddisseminationofscientific
information.2 Regulatory writing steers the
draftingandsubmissionofregulatorydossiers
and safety reports for health authorities;
publication writing (PW) on the other hand
deals with scientific publications, such as
manuscripts, abstracts, presentations, and
posters and falls under commercial writing.3
PWisregulatedbymanypublication-specific
guiding principles, such as good publication
practice (GPP), recommendations of the
international council of medical journal
editors (ICMJE), consolidated standards on
reportingtrials(CONSORT),thecommittee
onpublicationethics(COPE)guidelines,and
many others.1,3,4,5
With new stringent trial disclosure
policies and an industry-wide obligation to
submit trial results with medical importance
for publication, the importance of manu-
script publication has increased. The
publication of drug research in reputed
journals and at congresses increases the
impact of the results in the scientific
community and is a major channel of
communication of scientific advances to a
wide range of healthcare providers.1,2 A
staggering number of scientific publications
arepublishedeachyear,withscientificoutput
doubling every nine years.6 Many well-
known universities across the globe, such as
theJohnHopkinsUniversity,7 theUniversity
of Chicago Graham School,8 and the
Massachusetts Institute of Technology9 to
name a few, have already launched courses
and curriculum on medical publication/
science writing and editing. Many universit-
ies even have a department dedicated to
scientific publishing that keeps track of all
publications and supports their drafting and
editing. Nowadays various international
research institutes and government agencies
fund academic research with potential, with
a component of the grant allocated for
publication support.1,2
McGuigan and Russell10 noted that the
scientific, technical, and medical segment of
the academic journal publishing industry
generates more than US$19 billion revenue
globally. Scientific publication has increased
rapidly with the advent of highly soph-
isticated publication planning tools such
as PubSTRATTM
(from Sylogent) and
DataVisionTM (from Envision pharma
group). Publication planning tools have
revolutionised the publication industry by
accelerating the planning and execution of
publication projects.1,2,3,6
All these particulars illustrate that
medical PW is emerging as one of the most
important departments in pharmaceutical
companies, publication houses, and clinical
research organisations (CROs). Due to the
huge expenditure of time and money in
addition to regular expenses such as research
and manufacturing, many pharmaceutical
companies outsource PW work to CROs or
pharma knowledge processing and out-
sourcing (KPO) companies. Irrespective of
the type of company, there is always a
requirement to have set processes in place
for the seamless execution of a project,
which brings the principles of project
management into the picture. Challenges
faced in the execution of PW projects are
unique and different than those faced in
conventional regulatory medical writing. In
this article, we discuss project management
in the PW department of a pharmaceutical
company or a CRO/KPO.
Figure 1: Publication writing team structure Abbreviations: PW, Publication writing; CRO,
Clinical research organisation; KPO, Knowledge processing and outsourcing
Note: PW team 1, 2, 3 represents PW teams working on various deliverables/projects.
Final approvers of
publication
document
• Product team lead
• Clinical team lead
• Statistics lead
• Medical affairs lead
• Regulatory affairs
lead
• Legal
• Patents
• Principal authors
• Publication writers
• Project managers
• Outsourced work to
agency (CRO, KPO)
3. Auti / Pandey / Shah – Project management in medical publication writing
38 | March 2016 Medical Writing | Volume 25 Number 1
Project Management in
Medical Publication Writing in
line with the PMBOK
Framework
Before discussing the actual process of
project management in PW, let us first
understand the structure and function of a
PW team in a pharmaceutical company or
CRO. A PW team comprises trained
professionals who have higher degrees in the
life science domain, including, but not
limited to, pharmacy, medicine, and clinical
research. The schematic depiction of the
working of a PW team is shown in Figure 1.
The structure of a PW team may however
vary depending on the functionality and size
of the organisation .1,2,3
We propose a process of managing a PW
project in line with the five process groups
recognised in the Project Management Body
of Knowledge (PMBOK) published by the
Project Management Institute (PMI).11
Among the many different deliverables in
PW projects, most frequently encountered
are abstracts, posters, and manuscripts.
Development of any medical publication
document can be divided into five process
groups: Initiation, Planning, Execution,
Monitoring and Control, and Closing
(Figure 2).11
Initiation
Publication planning is a key aspect in the
project management of PW. A publication
plan is developed by the publication steering
committee and scientific publication team,
with the involvement of the publication lead
and writers. The publication plan is dev-
eloped in line with the drug development
and product life-cycle by considering
evaluations such as the needs assessment,
and internal and external gap analyses. The
publication planning team plans public-
ations at every stage of drug development
and also based on the medical queries they
receive at the medical information
management department.12,13
Project management in medical PW
begins with the definition of the objectives
and scope of the project. While pharma-
ceutical companies have a publication
plan12 ready as part of a drug’s develop-
ment, project management of a PW project
in a CRO varies in the processes followed.
In the case of CROs, the project is
understood by communicating with the
client (usually a pharmaceutical company
or other service provider agency) and the
drafting of a statement of work or a project
charter. This is often achieved by
conducting a kick-off meeting following a
formalised handover from business
development to operations. The very first
step to initiate the project is requirement
gathering, where open-ended questions are
asked to determine the project
specifications. For example, to develop a
manuscript, the following particulars can
clarify project specifications: author docu-
mentation (debarment, legal agreements
with external authors, authorship invitat-
ion), availability of data sources (reports,
existing publications, study protocol,
statistical plan, or any other data source),
the need for a comprehensive literature
search (important for reviews and meta-
analyses), quality control (data and editorial
checks), and the number of review
cycles.14,15 In the case of a CRO project,
the scope should be discussed in great detail
with the client so that the expectations of
both parties are aligned. For example, if the
CRO is requested to use the client’s
standard operating procedures (SOPs),
they should be analysed to see if they will
affect the time management aspects of the
project. After the scope is defined and
understood, internal research and
discussion are conducted and a solution is
devised. Internal team meetings are
arranged where the project manager and
medical writers discuss how to proceed
with the project. The strategies and
processes to be followed for the timely
delivery of the project are defined, i.e. the
project is set up in a publication planning
tool where timelines and stakeholders for
each draft stage (initial draft, first draft,
second draft, and final draft) of the
deliverable (manuscript/poster/abstract)
are defined.16 After the requirement
gathering, internal research and preparatory
activities are carried out to determine the
deadline for each milestone. This includes
the sharing of a content outline and getting
its approval from the client. Cost estimates
for publication planning in pharmaceutical
companies are prepared by the publication
steering committee and the finance
department. In CROs, they are usually
prepared during the business development
phase while negotiating with the client.
Estimated project hours and billable hours
per resource are taken into consideration to
develop a cost estimate.11,12,13
Planning
The planning stage begins once all project
specifications are defined and a unique
solution has been proposed. The first step is
Figure 2: Implementation of project management based on PMBOK framework
4. Project management in medical publication writing – Auti / Pandey / Shah
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 39
the assignment of project roles, which can
be achieved based on the skills documented
in the work profile of the writer and the
writer’s position in the organisation. A
writer’s work profile should be well cate-
gorised with regard to their competencies,
prior experience, and their therapeutic area
expertise. Tasks such as complex manu-
scripts, manuscripts, or posters with limited
data sources, review articles, and primary
manuscripts can be handed over to a senior
publication writer who has ability to
interpret statistical data whereas the task of
drafting an encore abstract or poster can be
given to a junior publication writer.17 In the
case of CROs where there are no dedicated
project managers, the publication lead might
work as a writer-cum-project-manager and
manage internal and external communic-
ations. He/she also has to ascertain if the
contribution of assistant teams, such as
publication technical support (handling the
publication tracking tool and other tech-
nicalities) or the graphic design team, is
needed, and if yes, to what extent. The
availability of resources with the required
skills at a given time can be tracked using
online time management tools and a
common project tracker sheet.11,17 An
example of a project tracker sheet is
provided in Table 1.
The availability of full-time employees
should be assessed quarterly as to whether
there is a need to allocate work to free-
lancers,otheragencies,orvendors.17 Overall
availability is calculated based on the
number of project and non-project hours.
Non-project hours include employee leave
and activities such as skillset training, self-
learning, corporate activities, SOP training,
and the maintenance of the staff training
folders. While assigning project roles, the
project manager should always pay heed to
the requirement of a back-up writer as part
of the risk mitigation strategy. A back-up
writer can do “fire-fighting” in cases where
the primary writer is unavailable due to ill-
health or other emergent work. Meticulous
resource planning is important to the
successful implementation of the project,
since the definition of the project roles and
the formation of the project team are based
onthis.Aresponsibilityassignmentmatrix18
is one such tool to define project roles in
cross-functional/inter-departmental
business/project processes. An example of
responsibility assignment matrix in a PW
project for writing a manuscript is given
below (Table 2).19
Once the project roles have been
assigned, a work breakdown structure20 is
created where an activity is divided into
smaller tasks and these tasks are assigned to
team members. An example of a work break-
down structure for writing a manuscript is
given in Figure 3 overleaf.
Execution
The execution phase in medical writing
includes working in accordance with SOPs
to complete a particular task. For PW, it
basically involves the drafting of the docu-
ment, review cycles, performing quality
checks, and addressing comments provided
by internal and external stakeholders.
Sometimes project managers also have to
deal with external agencies, giving rise to
vendor management. In the case of CROs,
vendors could include translation agencies,
printing and publishing support vendors, or
freelance service providers.
Pharma Brand Study Deliverable Write Subject Quality Start End Actual
company Name ID matter reviewer date date project
(Generic expert hours
name) reviewer
A X 1A Manuscript P CD DE 1-Jun-15 12-Aug-15 105
B Y 1B Congress poster Q GH HI 7-Jun-15 28-Jun-15 64
C Z 1C Scientific R LM MN 2-Jun-15 11-Jun-15 18
abstract
Table 1: An example of a project tracker sheet
Tasks Technical Project Publication Review Authors Approvers Graphic
Assistant Manager Writer Team Designer
Requirement gathering and project set up R R, A C, I O C O O
Kick-off and author documentation R R, A R, I O R, C, I O O
Drafting and comment addressing O A R O C O O
Review of the first draft O A I R R O O
Design work; creating tables,
figures, layout, etc
O A R, C I C, I O R
Review of the final draft O A I R R O O
Final approval O A R O I R O
Submission R A A O I I O
Adapted from: Dubois B. Fostering collaboration. The Write Stuff. 2011;20(4):219-21.
Abbreviations: R, Responsible; A, Accountable; C, Consulted; I, Informed; O, Omitted from the loop.
Note: the lead statistician is generally listed as an author; this matrix may change as per organisation structure and its requirements
Table 2: An example of a responsibility assignment matrix for writing a manuscript
5. Auti / Pandey / Shah – Project management in medical publication writing
40 | March 2016 Medical Writing | Volume 25 Number 1
Offshore operations management is
important for CROs working in different
geographical locations all over the globe.
Offshore operations are carried out through
a global hybrid delivery model considering
geographical, cultural, and chronological
variations. The project manager drives
execution against the plan and has to
communicate regularly and openly with the
sponsor.14,17,21
We shall now review the important steps
in the drafting of a manuscript. Initially, a
shell draft is written that includes all
important subject matter points in the form
of bulleted text for the introduction and
discussion sections and text paragraphs for
the methods and results sections. Comm-
ents requesting input or suggestions to
researchers or authors are put in the shell
draft. Once the shell draft is approved, the
first draft of the manuscript is written with
input from researchers and authors. Once
the first draft is written, the scientific
content of the entire manuscript is reviewed
by the core publication planning team and
comments are provided in case of incon-
sistencies, which are then addressed by the
publication writers. Once the first draft is
approved, the writers prepare the second
draft in accordance with the journal
guidelines. The second draft is generally
considered to be the final draft; however
additional drafts can be made depending on
the number of review cycles and project
requirements. Stakeholders involved in final
approval are the researchers, medico-legal
team, intellectual property team, regulatory
team, statistics head, and the clinical team
head.14,17,21
The line of reviews includes an in-house
review by an internal subject matter expert
(SME) and an editor. SME review involves a
diligent check of the scientific content, the
correct interpretation of the data, important
discussionpoints,toneoftheoverallmessage
(language should not sound promotional),
and the proper citation of references. In the
case of CROs, points of contact (POCs)
from the sponsor (i.e. the client) will review
the content from their perspective. Editorial
review is done by the medical editors to
check grammar and language. The writer-
cum-project manager acts as a bridge during
such reviews as they communicate and
address comments, meticulously check
content, propose solutions, and involve the
statistician or main author regarding any
queries.
Submission of the manuscript to the
journal or conference involves a mock
Figure 3: Work breakdown structure for drafting a manuscript. Abbreviations: IPR, Intellectual property rights
Address
Journal comments
Galley proof
Shell draft (key
pointers of
manuscript)
First draft (content
development +
formatting)
Author’s
documentation,
debarment checks
Journals selection
and literature search
Final draft
(recreating figures,
review, and edits)
Journal submission
(preparing
submission
package)
Timeline setup and
resource allocation
in publication
planning tool
Approvals from all
stakeholders (authors,
medico-legal, clinical
team, IPR, etc)
Collection or
requirement
gathering document
and data sources
Pre-submission
quality check
Preparatory activities Draft phase Submission
Post-submission
activities
Preparatory activities Draft phase
Writing a manuscript
Post-submission
activities
6. Project management in medical publication writing – Auti / Pandey / Shah
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 41
submission with the help of the publication
technical expert, preparation of a sub-
mission package, and communicating with
the journal or conference secretariat.
Monitoring and Control
The monitoring and control phase of a
project consists of risk management meas-
ures and review by the stakeholders. As
Murphy’s Law says ‘Anything that can go
wrong will go wrong’ and risks are
associated with every project. Risk man-
agement is one of the most critical aspects
of project management. Hence the risk
identification and mitigation plan should
always be at the disposal of the project
manager. It is important to list all possible
risks that may be encountered in the project
and have an action plan ready so that the
risks do not become issues. An example of a
risk register is shown in Table 3.11,16,22
Corrective action and preventive action
(CAPA) is another approach for managing
risks.23 Corrective action aims at correcting
an existing non-conformity and to avoid
recurrence of the same non-conformity.
Corrective action comes into the picture
when issues have been logged or risks have
been identified during audit findings, major
client reviews, etc. Preventive action on the
other hand aims to avoid the initial
occurrenceofnon-conformitybyproactively
implementing improvements. In brief,
CAPA acts as a solution to the issues or risks
encounteredinthelightofintegratedquality
management. Gantt charts can be used to
note employee engagement and to track the
timelines of the project. One more way of
trackingdeviationintheprocessandkeeping
corrective measures ready is by employing a
fishbone analysis (Ishikawa diagram). A
fishbone analysis for deviations and their
proposed solutions for a PW project are
given in Figure 4.
Closure
Project closure involves close-out docu-
mentation and review meetings. Close-out
documentation is a final information dossier
and includes all the relevant project-related
logs, minutes-of-meeting reports, business
emails, etc. These documents contain all
important project specifications, decisions
made, and measures employed, as well as
information on the overall course of the
project. Important aspects captured in the
close-out dossier include risks and issues,
project quality, lessons learnt, and an overall
analysis underlining achievements made
and pitfalls encountered during the
execution. From the kick-off meeting to
project delivery, many lessons are learnt in
each phase of the process, which can be
discussed and shared as a group. The
mistakes made in the execution of the
project and solutions offered therein go into
a knowledge base to be used for future
reference. Special lessons learnt meetings are
arranged to broaden the knowledge and
troubleshooting experience of the resources
involved in the project.
Preparing a data sheet comprising all
Deliverable Risk Impact Action Plan
Conference abstract or Difficulties updating results Failure to disseminate • Publication team should plan
oral presentation or poster from ongoing clinical trials key results of trial pre-presentation meeting with clinical
or late-breaking clinical during conference lead to incorporate final data/results
trial results
Poster and oral presentation Failure to capture important Poster with no scientific • Prepare ancillary (back-up)slides in
for medical conference data due to limits on word impact, poster does not case of presentation
count, slide count, convey the intended • In case of poster, prepare handouts or
or poster size scientific message generate a QR code linked
with additional information
Manuscript writing Minimal data sources Manuscript may lack • Ask for credible sources, especially
provided by study sponsor impact the CSR of the study and arrange a kick-off
meeting with the authors to discuss
future directions and flow of manuscript
Manuscript writing Targeting high-tier journal Manuscript might be • Prepare a list of preferred journals with
with high rejection rate rejected or major revisions their specifications (impact
suggested by journal factor, rejection rate, circulation) from
leading to delayed publication planning tools and discuss
publication with authors
• Draft a pre-submission query to journals
regarding their interest to publish particular
research work
• Be ready with back-up journals and their
submission guidelinesAbbreviations: CSR,
clinical study report; QR, quick response.
Table 3: Example of a risk register for publication writing projects
7. Auti / Pandey / Shah – Project management in medical publication writing
42 | March 2016 Medical Writing | Volume 25 Number 1
detailed information about a project
compound (drug), such as the molecule ID,
history, generic term, drug class, and
pharmacology, safety, and efficacy studies of
that molecule, creates a knowledge base,
which can be utilised in the future. Closure
also involves keeping all documents in an
inventory, such as issue logs, logs of project
risks and mitigation strategies, and the
archiving of the published deliverable.
We have discussed how projects are
executed in medical writing organisations.
Let us now see the various issues faced in
project management. Barriers to effective
project management include communic-
ation hurdles, a lack of status-reporting
measures, a low accountability culture, and
conflicts in decision-making. Communic-
ation hurdles include language barriers or
different interpretations of the intended
message.Workingwithnon-Englishspeakers
can pose significant problems due to the
incomprehension of or misunderstandings
regarding requirements. Services of trans-
lation agencies and interpreters can help
overcome these issues. The project manager
should communicate clearly while interact-
ing with the POCs. The project manager
needs to be able to negotiate effectively with
vendors and should be endowed with good
interpersonal skills. Each resource working
on the project should be given ample
freedom as well as accountability for the
seamless execution of the project. There
should be an efficient risk reporting system
so that the risks do not become issues. In
addition, the project manager should be able
to manage resources and resolve conflicts.
The behavioural and communication
aspects of a manager are instrumental to the
progress of the project.24,25
Project Management in
Medical Publication Writing:
Future Directions
The success of the project lies in the several
process improvement methods and diligent
contribution of the assigned resources
promoting quick and smooth functioning.
Process improvement methods can further
help expedite project delivery timelines and
reduce costs. Capability maturity model
integration26 is a sophisticated process
improvement plan that can be implemented
by pharmaceutical companies as well as
CROs in medical affairs or medical writing
departments. In the case of CROs, capability
maturity model integration appraisal
additionally wins the confidence of the
client and can help attract new projects and
business for service industries. The global
hybrid delivery model, a relatively new
approach to carrying out project work in
Figure 4: Risk mitigation fishbone analysis. Abbreviations: POC, Point of contact
(Acts as a bridge between medical writer and authors and other stakeholders)
Fishbone analysis for publication projects (writers, authors, POCs, and project management)
• Prompt
communication/
regular follow ups/
problem solving
approach
• Weekly updates from
writer to respective
POC
• Back up writer for
each project
• Assessment of writers’
workload before
accomodatig any ad
hoc request
• Back up POCs
• Write should follow
same process with all
POCs regarding
timelines and
documentation
• Always send timelines
to authors/POCs
before starting any
project
• Write should start
communication
regarding their project
in advance
• Write should check
status of their submitted
manuscrips regularly
• Promptcommunication/
regular follow ups from
writer/POC (if required)
• To categorise the
projects on the basis of
timelines/difficulty level
for better project
allocation
• Monthly meeting of
POCs/writers to discuss
project details/support
required from POC
Timeline
slippages and
increased
ovesight
Lack of
communication
with author/POCs
Delayed response with no
scientific inputs
Project kept on
back burner
High priority/no priority
publications
Providing incomplete data sources,
setting high expectations of writers
Writer with multiple
projects is on leave
Ad hoc requests
Cannot decide
author’s timeline
Measures taken/proposed
solutions
Reasons for timeline slippage
Main outcomes
POC is on leave Project is on hold
Lack of support/
different work style
Journal response for
major revisions
Publication POCs Project Management
Publication writer Authors
P U BL I C AT I O N W R I T I N G
8. Project management in medical publication writing – Auti / Pandey / Shah
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 43
accordance with client specifications in
CROs, enables the seamless execution and
delivery of a project. It basically involves two
working teams, one offshore and the other
onsite, which coordinate with the client and
each other to give effective output. The lean
six sigma initiative is a business improve-
ment strategy that aims to improve team
performance by integrated efforts and
removing redundancy. This business strat-
egy improves cross-functional teamwork in
any process driven service industry and also
reduces the cost of poor quality resulting
from late delivery, customer complaints,
costs associated with misdirected problem
solving, etc.27 There have been attempts at
harmonising and implementing lean six
sigma and PMBOK principles in pharma-
ceutical organisations.28,29 The future of
any product, process, or service lies in
innovation.Novelandinnovativeapproaches
that minimise process hurdles and make
project execution smooth and error free are
the future ideals of project management.
Conflicts of Interest and
Disclaimers
The authors declare no conflict of interest.
The opinions expressed here are solely those
of the authors and not necessarily those of
SIRO Clinpharm Pvt Ltd.
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Correspondence to:
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6 Stoneycroft Rise
Chandlers Ford
Eastleigh, Hants
United Kingdom, SO53 3LD
Tel +44 (0)2380 688713
Alison.McIntosh@iconplc.com
Abstract
Alison McIntosh successfully operated as
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Auti / Pandey / Shah – Project management
in medical publication writing
44 | March 2016 Medical Writing | Volume 25 Number 1
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Author information
• Prashant Auti, MS (Pharm) has
experience of working in the medical
communications, HEOR, and
medical publication writing groups of
various organisations. He has
supported scientific writing activities
for several pharmaceutical giants.
Prashant is currently associated with
the scientific writing and
communications team of SIRO
Clinpharm Pvt Ltd, India.
• Rishabh Pandey, PhD is associated
with the scientific writing and
communications team at SIRO
Clinpharm Pvt Ltd, India. He has
more than 20 publications to his
credit in numerous peer reviewed
journals and experience as a journal
reviewer. As a publication writer he
has supported the publication groups
of various pharmaceutical companies.
• Vatsal Shah, MD has vast experience
in medical writing. He has been
involved in establishing and managing
medical writing departments across
different pharmaceutical companies
in India. He is currently working as
chief operating officer at SIRO
Clinpharm Pvt Ltd, India.
Never say never!
Returning to full-time
employment after
freelancing