CRO
This document provides an overview of a CRO's full-service clinical data management capabilities. It has over 25 years of experience and a team of 70 staff across Europe and India. The CRO offers a full range of CDM services including project management, database design, data entry, validation, and IT infrastructure validated to industry standards. It has experience across therapeutic areas and geographies, using mature CDISC-compliant platforms. The CRO maintains data security, backup/recovery policies, and has qualified experienced staff to deliver high-quality CDM services.
YEARS
Track Record
Data integrity is assuming greater importance in current Good Manufacturing Practices in FDA regulated industry with increased emphasis by other regulatory agencies like the EMA. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations. As FDA increases its focus on data integrity and reliability, inspectors are examining data based on multiple regulations and standards including CGMP, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and the Application Integrity Policy (AIP) in addition to FDA-recognized consensus standards.
This presentation discusses data integrity regulations and enforcement trends that have led to increased scrutiny of pharmaceutical laboratories by inspectors.
Reconciliation and Literature Review and Signal Detection_Katalyst HLSKatalyst HLS
Introduction Reconciliation and Literature Review and Signal Detection in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
E2B(R2) and E2B(R3) are standards for electronic transmission of individual case safety reports (ICSRs). E2B(R3) was developed through a new collaborative approach between several international organizations, whereas E2B(R2) was developed by ICH alone. E2B(R3) uses a hierarchical data structure and is more standardized and interoperable compared to E2B(R2). The increased standardization of E2B(R3) allows for better exchange of safety information.
This document discusses regulatory requirements and previous observations related to data integrity issues. It outlines criteria for integrity of laboratory data according to regulations. It also provides examples of possible data integrity problems that have been observed by regulators, such as altering raw data, manipulating test procedures to obtain passing results, and recording lab activities before they occur. FDA warning letters from 2013 are referenced that identified specific failures to record quality activities at the time they were performed.
FDA Inspections ( How to Survive an FDA Inspection).pptshaik malangsha
This document provides guidance on how to prepare for and survive a FDA inspection of a clinical trial site. It discusses the different types of inspections, including routine inspections triggered by an application submission and for-cause inspections due to complaints. When receiving notice of an inspection, key steps are to obtain inspection details, notify relevant parties, and prepare documents and staff. During the inspection, FDA inspectors will verify protocol adherence and delegation of duties. Answering questions honestly and avoiding speculation are important.
Signal detection and management activities are at the core of ensuring drug safety. A complex process of signal detection; through their validation and confirmation; analysis and prioritisation; and signal assessment to recommending action.
Find out more at out training: http://bit.ly/1W31NCF
Data integrity is assuming greater importance in current Good Manufacturing Practices in FDA regulated industry with increased emphasis by other regulatory agencies like the EMA. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations. As FDA increases its focus on data integrity and reliability, inspectors are examining data based on multiple regulations and standards including CGMP, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and the Application Integrity Policy (AIP) in addition to FDA-recognized consensus standards.
This presentation discusses data integrity regulations and enforcement trends that have led to increased scrutiny of pharmaceutical laboratories by inspectors.
Reconciliation and Literature Review and Signal Detection_Katalyst HLSKatalyst HLS
Introduction Reconciliation and Literature Review and Signal Detection in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
E2B(R2) and E2B(R3) are standards for electronic transmission of individual case safety reports (ICSRs). E2B(R3) was developed through a new collaborative approach between several international organizations, whereas E2B(R2) was developed by ICH alone. E2B(R3) uses a hierarchical data structure and is more standardized and interoperable compared to E2B(R2). The increased standardization of E2B(R3) allows for better exchange of safety information.
This document discusses regulatory requirements and previous observations related to data integrity issues. It outlines criteria for integrity of laboratory data according to regulations. It also provides examples of possible data integrity problems that have been observed by regulators, such as altering raw data, manipulating test procedures to obtain passing results, and recording lab activities before they occur. FDA warning letters from 2013 are referenced that identified specific failures to record quality activities at the time they were performed.
FDA Inspections ( How to Survive an FDA Inspection).pptshaik malangsha
This document provides guidance on how to prepare for and survive a FDA inspection of a clinical trial site. It discusses the different types of inspections, including routine inspections triggered by an application submission and for-cause inspections due to complaints. When receiving notice of an inspection, key steps are to obtain inspection details, notify relevant parties, and prepare documents and staff. During the inspection, FDA inspectors will verify protocol adherence and delegation of duties. Answering questions honestly and avoiding speculation are important.
Signal detection and management activities are at the core of ensuring drug safety. A complex process of signal detection; through their validation and confirmation; analysis and prioritisation; and signal assessment to recommending action.
Find out more at out training: http://bit.ly/1W31NCF
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
Insights and Trends from 2021 FDA GCP Inspections.pptxMMS Holdings
The document summarizes insights and trends from the FDA's 2021 GCP inspections. It provides an overview of total inspections, top 483 observations for drugs and devices, and warning letters. Key findings include COVID-19 reducing inspections and alternative tools being used, top drug and device 483 observations relating to documentation and procedures, and most warning letters issued in March and October relating to drugs. It also discusses anticipated changes from the draft ICH E6(R3) guideline and trends for 2022, such as a potential increase in enforcement and focus on data security, quality controls, and corrective actions.
Clinical Data Management Training @ Gratisol LabsGratisol Labs
Clinical data management involves processing clinical trial data using computer applications and database systems. It supports the collection, cleaning, and management of subject data. Key aspects of clinical data management include CRF design, database setup, data entry, discrepancy management, medical coding, quality control, and database lock. The goal is to ensure the integrity and quality of clinical trial data.
Optimizing management of clinical trial supply chains through improved visibi...SPLY ApS
Introduction slides for the workshop on best practice for optimizing the clinical supply chain visibility held at the Clinical Trials Supply Forum 2018 conference in London.
ISO IDMP: Practical considerations from XEVMPD experienceQdossier B.V.
ISO IDMP (Identification of Medicinal Products) is coming! What lessons can we learn from our practical exprience with XEVMPD in preparation for IDMP? Topics include data cleaning, managing inconsistencies across product registrations and countries and controlled vocabularies
This presentation summarizes the key requirements of the EU Delegated Regulation on safety features for medicinal products. It describes the obligations to prevent falsified medicines, including applying a unique identifier and anti-tampering device. It outlines the core elements of the regulation, such as the composition of the unique identifier, end-to-end verification system, and establishment of repositories to store unique identifiers. The regulation aims to implement traceability systems to securely track medicinal products and help prevent entry of falsified medicines into the legal supply chain.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
A guide for how to survive a FDA Warning letter. So you got at FDA 483 and now you have a FDA Warning Letter, learn how to survive the storm. For more information go to http://compliance-insight.com/fda-483-warning-letters/
The document describes a regulatory software system that:
1. Manages regulatory activities and tracks progress for product registrations across countries.
2. Produces regulatory summaries and creates tasks for registration and lifecycle management activities.
3. Generates alerts when tasks are late and tracks agency correspondence.
This document discusses data integrity in pharmaceutical quality systems. It defines data and explains its importance in decision making and continual improvement. It notes that the FDA and EMA have issued warning letters and non-compliance reports for data integrity issues. Examples are provided of warning letters issued to two companies for violations like unauthorized data manipulation, lack of audit trails, and insufficient investigations. The causes of data integrity breaches are discussed. It emphasizes establishing a culture of integrity, security protocols, and complying with cGMP guidelines. It provides details on how to properly manage system access, data storage, backups, and recording data according to ALCOA principles. The importance of audit trail software is also covered.
This document provides a summary of guidelines for good clinical practice (GCP) according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It discusses the purpose and scope of GCP, which is to ensure proper design, conduct, and reporting of clinical trials involving human subjects. Key topics covered include ethics review, responsibilities of investigators and sponsors, informed consent of subjects, clinical trial documentation and record keeping. The document emphasizes protecting the rights, safety and well-being of clinical trial subjects.
Data integrity refers to the completeness, consistency, and accuracy of data. The data should follow the ALCOA principles: Attributable, Legible, Contemporaneous, Original, and Accurate. A lack of data integrity can lead to warning letters from regulators, import alerts, and no further product approvals. Typical contents of warning letters include failing to investigate complaints, falsifying documentation, and improperly recording batch information. Maintaining data integrity is important to avoid regulatory consequences.
FDA Data Integrity Issues - DMS hot fixesVidyasagar P
The document discusses data integrity, including popular causes of integrity issues, consequences, and fixes related to document management systems. It provides definitions of data integrity and discusses regulatory requirements around integrity from agencies like the FDA. Specifically, it summarizes the FDA's 21 CFR Part 11 regulation, which considers electronic records equivalent to paper if certain controls are in place. It also discusses application integrity policies and concludes that ensuring data integrity is important to rebuild regulatory trust if issues are found.
Feasibility Solutions to Clinical Trial Nightmaresjbarag
Slow patient recruitment and poor retention cause recurrent nightmares and perpetual problems often resulting in missing recruitment milestones. The cost of these delays represents hundreds of thousands of dollars for drug and device developers. By recognizing this issue, early detailed feasibility can provide planning and contingency solutions that are focused on reducing the impact of delayed recruitment. Furthermore understanding what motivates investigators and patients to actively participate in clinical studies and how patient recruitment strategies and materials can support all stakeholders to complete studies on time are critical aspects of clinical study delivery planning.
During this presentation, an experienced Premier Research feasibility and patient recruitment specialist, reviewed feasibility approaches to address protocol evaluation as well as addressed influences on country selection, site distribution and patient recruitment strategies to provide for more effective clinical trial planning and conduct.
For more information, go to http://www.premier-research.com.
The document defines FDA warning letters and describes the process of FDA inspections that can lead to warning letters. It explains that warning letters notify companies of violations found during inspections and investigations. Companies must promptly correct issues and FDA will check that corrections are adequate. The document also describes different types of warning letters for various regulated industries and how to browse existing warning letters on the FDA website.
Why is Regulatory Information Management (RIM) Important?Appian
How can you be you are compliant with all regulations when there are so many to manage? Learn how leading life sciences companies are using new processes, as well as new technologies to create tailor-made solutions, enabling global strategies in regulatory operations in this complimentary on-demand webinar: http://ap.pn/2eLrMAP
The document discusses the role of the EU Qualified Person for Pharmacovigilance (QPPV). The QPPV must be appropriately qualified, reside in the EEA, and act as a single point of contact for drug safety issues in Europe. The QPPV is responsible for establishing and maintaining the company's pharmacovigilance system, monitoring product safety, submitting regulatory documents, and ensuring compliance with European legislation on safety reporting and risk management. Both the marketing authorization holder and QPPV have overlapping obligations to support pharmacovigilance activities and ensure the safe use of medicinal products in the EU.
Planning for the New Individual Case Safety Report (ICSR) International Stand...Perficient
This document summarizes a presentation about upcoming changes to the standards for reporting individual case safety reports (ICSRs) and identifying medicinal products. Key points include: 1) New IDMP standards will be introduced to uniquely identify products, substances, and other attributes. 2) A new ICSR format called E2B(R3) will improve reporting quality and allow attachments. 3) Implementation guides for E2B(R3) are being finalized by international and European regulators. 4) Software vendors expect to support the new standards in upcoming versions beginning in 2013. Attendees are advised to upgrade safety reporting systems and plan for electronic reporting changes.
This document discusses audits and inspections in clinical trials. It defines an audit as a systematic examination of trial activities and documents to determine compliance, while an inspection involves a regulatory review of documents, facilities, and resources related to a trial. The key differences between audits and inspections are that audits are conducted internally by sponsors or CROs, while inspections are done by regulatory authorities. Routine audits ensure compliance, while for-cause audits investigate non-compliance issues. Audits and inspections evaluate areas like personnel, trial conduct, documentation, drug accountability, and computer systems. Proper preparation and responding to document requests within time limits are important for audits and inspections.
GAMP 5 provides a framework for validating computerized systems used in regulated industries. It recommends a life cycle approach involving quality risk management throughout planning, development, validation and operation. Key activities for regulated companies include governance, identifying systems' impact, and ensuring compliance. Suppliers play an important role by providing documentation, testing systems, and supporting changes and maintenance. The level of validation should be based on a system's risk, complexity and novelty.
An brief introduction to the clinical data management process is described in this slides. These slides provides you the information regarding the data evaluation in the clinical trials , edit checks and data review finally data locking,then the data is submitted to the concerned regulatory body.
The document provides an overview of clinical data management (CDM) responsibilities and processes. It discusses the CDM mission of ensuring high quality, consistent, accurate and valid data collection. Key CDM responsibilities include protocol review, database design, data entry, verification, coding, query resolution and ensuring data quality. The CDM process involves multiple stages from database design to data transformation and locking. Medical coding systems like MedDRA are used to standardize adverse event and medical condition terms. Case report forms and logging procedures are also outlined.
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
Insights and Trends from 2021 FDA GCP Inspections.pptxMMS Holdings
The document summarizes insights and trends from the FDA's 2021 GCP inspections. It provides an overview of total inspections, top 483 observations for drugs and devices, and warning letters. Key findings include COVID-19 reducing inspections and alternative tools being used, top drug and device 483 observations relating to documentation and procedures, and most warning letters issued in March and October relating to drugs. It also discusses anticipated changes from the draft ICH E6(R3) guideline and trends for 2022, such as a potential increase in enforcement and focus on data security, quality controls, and corrective actions.
Clinical Data Management Training @ Gratisol LabsGratisol Labs
Clinical data management involves processing clinical trial data using computer applications and database systems. It supports the collection, cleaning, and management of subject data. Key aspects of clinical data management include CRF design, database setup, data entry, discrepancy management, medical coding, quality control, and database lock. The goal is to ensure the integrity and quality of clinical trial data.
Optimizing management of clinical trial supply chains through improved visibi...SPLY ApS
Introduction slides for the workshop on best practice for optimizing the clinical supply chain visibility held at the Clinical Trials Supply Forum 2018 conference in London.
ISO IDMP: Practical considerations from XEVMPD experienceQdossier B.V.
ISO IDMP (Identification of Medicinal Products) is coming! What lessons can we learn from our practical exprience with XEVMPD in preparation for IDMP? Topics include data cleaning, managing inconsistencies across product registrations and countries and controlled vocabularies
This presentation summarizes the key requirements of the EU Delegated Regulation on safety features for medicinal products. It describes the obligations to prevent falsified medicines, including applying a unique identifier and anti-tampering device. It outlines the core elements of the regulation, such as the composition of the unique identifier, end-to-end verification system, and establishment of repositories to store unique identifiers. The regulation aims to implement traceability systems to securely track medicinal products and help prevent entry of falsified medicines into the legal supply chain.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
A guide for how to survive a FDA Warning letter. So you got at FDA 483 and now you have a FDA Warning Letter, learn how to survive the storm. For more information go to http://compliance-insight.com/fda-483-warning-letters/
The document describes a regulatory software system that:
1. Manages regulatory activities and tracks progress for product registrations across countries.
2. Produces regulatory summaries and creates tasks for registration and lifecycle management activities.
3. Generates alerts when tasks are late and tracks agency correspondence.
This document discusses data integrity in pharmaceutical quality systems. It defines data and explains its importance in decision making and continual improvement. It notes that the FDA and EMA have issued warning letters and non-compliance reports for data integrity issues. Examples are provided of warning letters issued to two companies for violations like unauthorized data manipulation, lack of audit trails, and insufficient investigations. The causes of data integrity breaches are discussed. It emphasizes establishing a culture of integrity, security protocols, and complying with cGMP guidelines. It provides details on how to properly manage system access, data storage, backups, and recording data according to ALCOA principles. The importance of audit trail software is also covered.
This document provides a summary of guidelines for good clinical practice (GCP) according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It discusses the purpose and scope of GCP, which is to ensure proper design, conduct, and reporting of clinical trials involving human subjects. Key topics covered include ethics review, responsibilities of investigators and sponsors, informed consent of subjects, clinical trial documentation and record keeping. The document emphasizes protecting the rights, safety and well-being of clinical trial subjects.
Data integrity refers to the completeness, consistency, and accuracy of data. The data should follow the ALCOA principles: Attributable, Legible, Contemporaneous, Original, and Accurate. A lack of data integrity can lead to warning letters from regulators, import alerts, and no further product approvals. Typical contents of warning letters include failing to investigate complaints, falsifying documentation, and improperly recording batch information. Maintaining data integrity is important to avoid regulatory consequences.
FDA Data Integrity Issues - DMS hot fixesVidyasagar P
The document discusses data integrity, including popular causes of integrity issues, consequences, and fixes related to document management systems. It provides definitions of data integrity and discusses regulatory requirements around integrity from agencies like the FDA. Specifically, it summarizes the FDA's 21 CFR Part 11 regulation, which considers electronic records equivalent to paper if certain controls are in place. It also discusses application integrity policies and concludes that ensuring data integrity is important to rebuild regulatory trust if issues are found.
Feasibility Solutions to Clinical Trial Nightmaresjbarag
Slow patient recruitment and poor retention cause recurrent nightmares and perpetual problems often resulting in missing recruitment milestones. The cost of these delays represents hundreds of thousands of dollars for drug and device developers. By recognizing this issue, early detailed feasibility can provide planning and contingency solutions that are focused on reducing the impact of delayed recruitment. Furthermore understanding what motivates investigators and patients to actively participate in clinical studies and how patient recruitment strategies and materials can support all stakeholders to complete studies on time are critical aspects of clinical study delivery planning.
During this presentation, an experienced Premier Research feasibility and patient recruitment specialist, reviewed feasibility approaches to address protocol evaluation as well as addressed influences on country selection, site distribution and patient recruitment strategies to provide for more effective clinical trial planning and conduct.
For more information, go to http://www.premier-research.com.
The document defines FDA warning letters and describes the process of FDA inspections that can lead to warning letters. It explains that warning letters notify companies of violations found during inspections and investigations. Companies must promptly correct issues and FDA will check that corrections are adequate. The document also describes different types of warning letters for various regulated industries and how to browse existing warning letters on the FDA website.
Why is Regulatory Information Management (RIM) Important?Appian
How can you be you are compliant with all regulations when there are so many to manage? Learn how leading life sciences companies are using new processes, as well as new technologies to create tailor-made solutions, enabling global strategies in regulatory operations in this complimentary on-demand webinar: http://ap.pn/2eLrMAP
The document discusses the role of the EU Qualified Person for Pharmacovigilance (QPPV). The QPPV must be appropriately qualified, reside in the EEA, and act as a single point of contact for drug safety issues in Europe. The QPPV is responsible for establishing and maintaining the company's pharmacovigilance system, monitoring product safety, submitting regulatory documents, and ensuring compliance with European legislation on safety reporting and risk management. Both the marketing authorization holder and QPPV have overlapping obligations to support pharmacovigilance activities and ensure the safe use of medicinal products in the EU.
Planning for the New Individual Case Safety Report (ICSR) International Stand...Perficient
This document summarizes a presentation about upcoming changes to the standards for reporting individual case safety reports (ICSRs) and identifying medicinal products. Key points include: 1) New IDMP standards will be introduced to uniquely identify products, substances, and other attributes. 2) A new ICSR format called E2B(R3) will improve reporting quality and allow attachments. 3) Implementation guides for E2B(R3) are being finalized by international and European regulators. 4) Software vendors expect to support the new standards in upcoming versions beginning in 2013. Attendees are advised to upgrade safety reporting systems and plan for electronic reporting changes.
This document discusses audits and inspections in clinical trials. It defines an audit as a systematic examination of trial activities and documents to determine compliance, while an inspection involves a regulatory review of documents, facilities, and resources related to a trial. The key differences between audits and inspections are that audits are conducted internally by sponsors or CROs, while inspections are done by regulatory authorities. Routine audits ensure compliance, while for-cause audits investigate non-compliance issues. Audits and inspections evaluate areas like personnel, trial conduct, documentation, drug accountability, and computer systems. Proper preparation and responding to document requests within time limits are important for audits and inspections.
GAMP 5 provides a framework for validating computerized systems used in regulated industries. It recommends a life cycle approach involving quality risk management throughout planning, development, validation and operation. Key activities for regulated companies include governance, identifying systems' impact, and ensuring compliance. Suppliers play an important role by providing documentation, testing systems, and supporting changes and maintenance. The level of validation should be based on a system's risk, complexity and novelty.
An brief introduction to the clinical data management process is described in this slides. These slides provides you the information regarding the data evaluation in the clinical trials , edit checks and data review finally data locking,then the data is submitted to the concerned regulatory body.
The document provides an overview of clinical data management (CDM) responsibilities and processes. It discusses the CDM mission of ensuring high quality, consistent, accurate and valid data collection. Key CDM responsibilities include protocol review, database design, data entry, verification, coding, query resolution and ensuring data quality. The CDM process involves multiple stages from database design to data transformation and locking. Medical coding systems like MedDRA are used to standardize adverse event and medical condition terms. Case report forms and logging procedures are also outlined.
Clinical Data Management (CDM) is a critical phase in clinical research that leads to generating high-quality, reliable data from clinical trials. CDM involves collecting, integrating, and ensuring the availability of appropriate quality and cost data. It encompasses entering, verifying, validating, and quality controlling the data gathered during clinical trials. The goal of CDM is to ensure the data supports conclusions drawn from the research.
Clinical data is the most valuable asset to pharmaceutical companies as it serves as the basis for approval and marketing of new drugs. Clinical data is collected from various sources like clinical trial sites, laboratories, and subjects. It is important to manage clinical data carefully to minimize errors and ensure data quality. Clinical data management systems are used to store clinical trial data gathered at sites and help researchers analyze the data while maintaining accuracy and security. These systems employ features like double data entry, coding standards, and metadata repositories to organize data for regulatory submissions and clinical research.
Appalla Venkataprabhakar and I presented this at the Oracle\'s Annual Clinical Development and Safety Conference 2010 at Hyderabad, India on 6th October 2010.
Sharing CTMS Data Between Sponsors and CROsPerficient
The document discusses different methods for sharing clinical trial management system (CTMS) data between sponsors and contract research organizations (CROs). It begins with an introduction of the speaker and an overview of the clinical trial outsourcing trend. It then covers three main data sharing methods - CRO export/sponsor import, CRO access to sponsor CTMS, and CRO-sponsor CTMS integration. For each method, it discusses the benefits, drawbacks, and provides an example scenario analysis recommending the integration method. The presentation aims to help sponsors choose the best data sharing approach between themselves and CRO partners.
This document outlines the process of clinical data management. It discusses the key steps and technologies involved in digitization, electronic data capture, data analytics, document management, data standardization, and infrastructure/security. The main stages described are feasibility analysis, system selection, design and implementation, data collection, quality control, and regulatory submission preparation. Technologies mentioned include EDC tools like Oracle Clinical, data standards like CDISC SDTM, and document management solutions from vendors such as Documentum.
This document discusses clinical trial management systems. It describes key application areas such as protocol development, data collection and analysis, safety reporting, and regulatory submission. It outlines stakeholders in the clinical trial process like sponsors, investigators, and sites. It also explains how clinical trial systems support management of studies, sites, data, adverse events, and integration with external systems. Clinical trial systems help standardize, automate and manage the complex clinical trial process.
New drug development is a highly complex, costly, and time-consuming process that can take over 10 years. It involves synthesis of new chemical entities, preclinical studies in animals and cells to evaluate safety and efficacy, followed by clinical trials in humans in 4 phases to further assess safety and efficacy. If clinical trials are successful, regulatory approval must be obtained before the drug can be marketed. The overall goal is to bring new treatments to patients while ensuring safety and effectiveness through a rigorous scientific process.
The document discusses drug discovery and the new drug development process. It describes how drugs are developed to treat diseases, which can be infections, genetic disorders, or results of environmental conditions. The development process is long and complex, involving many scientific and technical experts. The document also provides numerous examples of plant-based drugs and the plants and chemicals they are derived from to treat various medical conditions.
Drug discovery and development is and always has been the most exciting part of clinical pharmacology. It is my attempt to compile the basic concepts from various books, articles and online journals. Feel free to comment.
Introduction to pre clinical screening of drugsKanthlal SK
Various Techniques and Methods for screening of new chemical entities in preclinical aspects (both invitro & invivo) for effective and safe clinical usage.
A presentation outlining the various processes a chemical compound undergoes (thorough & rigorous screening procedures) before it is finally introduced into the drug market
This document provides guidance on the Investigator's Brochure (IB), which compiles clinical and nonclinical data on investigational products relevant for human subject studies. The IB aims to inform investigators and others about the product's dose, administration, and safety monitoring. It also helps clinicians independently assess the risks and benefits of a proposed trial. The IB includes a summary of nonclinical pharmacology, toxicology, and human effects studies. It provides guidance to investigators on understanding the potential risks, adverse reactions, and precautions needed for safe clinical trial conduct.
Clinical trials involve several phases:
- Phase I trials involve small groups of healthy volunteers or patients and aim to determine the safety and tolerability of a new drug.
- Phase II trials involve larger groups of patients and aim to determine efficacy and further evaluate safety. These trials provide preliminary data on effectiveness.
- Phase III trials involve even more patients and aim to confirm effectiveness, monitor side effects, and compare the new treatment to standard treatment. These trials provide the primary data to support effectiveness. Regulatory approval is based on positive Phase III results showing safety and effectiveness.
The document discusses the key stages in the drug discovery and development process including target selection, compound screening and hit optimization, selecting a drug candidate through further optimization of properties like absorption and metabolism, safety testing in animals and humans, proof of concept clinical trials in patients, large phase 3 clinical trials for registration and approval, and finally launch and life cycle management. It notes that the entire process from discovery to approval can take 12-16 years and cost over $1 billion.
Preclinical trials involve testing new drugs and medical devices on animals before human testing to assess safety and efficacy. They include various studies such as screening tests, isolated organ tests, and toxicity tests on rodents and larger animals. The goals are to determine dosing, identify adverse effects, and collect sufficient safety data to file for approval to begin clinical trials in humans under good laboratory practices. Preclinical studies help establish that initial human trials can reasonably proceed safely.
The document provides information on several clinical data management systems and software, including Oracle Clinical, SAS Clinical Software, TCS Clin-E2E Software, Cognos 8 Business Intelligence Software, Symetric Software, Akaza's OpenClinica Software, SigmaSoft's DMSys Software, and Progeny Clinical Software. It discusses their key features for managing clinical trials data such as electronic data capture, reporting, security, compliance with industry standards, and integration with other systems.
This document discusses various clinical trial designs including parallel, crossover, factorial, and adaptive designs. It describes key elements of clinical trial methodology such as randomization, blinding, placebos, and controls. The document also outlines how clinical trial designs are applied differently in each phase of drug development from Phase 0 microdosing to Phase III confirmatory trials. Key challenges in clinical trial design like controlling bias and complex statistical analysis of factorial designs are also summarized.
Managing a public cloud involves three main roles: end users, developers, and infrastructure/datacenter managers. It presents challenges including maintaining security and reliability across devices for users, resources for developers, and leveraging remote services like performance and availability for managers. Providers offer enterprises, mid-market businesses, and consumers core capabilities like shared infrastructure, billing, and monitoring. Managing the cloud requires provisioning, processing, storing, and securing data across servers, applications, and compliance frameworks. Developing an integrated service catalog and managing across technical and business domains with multiple partners is key.
Cloud Lock-in vs. Cloud Interoperability - Indicthreads cloud computing conf...IndicThreads
Session presented at the 2nd IndicThreads.com Conference on Cloud Computing held in Pune, India on 3-4 June 2011.
http://CloudComputing.IndicThreads.com
Abstract:As the cloud adoption increases, there is a growing concern about the lock-in of customers into the various cloud platforms. This session will discuss various major cloud platforms, the type of lock-in the customer will face in each of these platforms and what each customer can do to minimize their lock-in.
Key takeaways for audience are:
Understand what is cloud lock-in
Types of cloud vendor lock-ins
What is cloud interoperability
Major initiatives around cloud interoperability standards
Goals, differences and players/proponents of these major standards
Steps to minimize cloud lock-in for your customers
Speaker: Ashwin Waknis is a Sr. IT professional with 15 years in the industry. Ashwin is currently head of the Cloud Professional Services Business at Persistent Systems. Before that Ashwin was a Sr. Product Manager at Cisco Systems where he lead major initiatives around Knowledge Management, Enterprise Portal, Web 2.0/Social softwares and Enterprise Search. For the last 2 years, Ashwin has been involved in Cloud Computing initiatives first at Cisco and then at Persistent Systems.Ashwin has spoken at many customer workshops and events organized for educational institutes.
Prodapt is a leading provider of IT and engineering services to telecommunication clients worldwide. It has delivery centers in the US, India, and South Africa and over 1000 employees globally. Prodapt partners with major telecom operators and OEMs, providing services such as network management, order fulfillment, billing, and product development. It aims to help clients reduce costs, optimize investments, and outsource effectively through flexible engagement models.
The document describes Netax's service delivery center (SDC), which offers managed services to partners. The SDC enables partners to expand their technical capabilities across geographies. It allows deployment of multi-technology, multi-location projects and provides high quality support to customers. Key benefits of the SDC include low startup costs, reduced support costs, increased revenues, and operational scaling without adding resources. The SDC features include 24/7 monitoring, a customer self-service portal, and multiple service support levels.
Rcm qad life sciences validation scripts and servicesLaura DeLea
RCM offers three options for computer system validation of the QAD ERP system: 1) purchasing all validation documents and protocols, 2) a team approach utilizing both RCM and client staff, or 3) a turnkey approach using only RCM staff. RCM consultants have experience preparing validation documents, executing protocols to test requirements are met, and producing a final validation report. Services include validation project management, document preparation, installation and operation qualifications, and ensuring FDA and GMP compliance.
Netax's Service Delivery Center provides managed services such as infrastructure, security, monitoring and reporting through a unified platform. The SDC enables partners to expand their technical capabilities and offer services to customers across multiple locations. Key benefits include low costs, reduced support costs, increased revenues and profitability through new business opportunities. The SDC features a 24/7 infrastructure, proactive monitoring, and customer self-service portal.
Remote Infrastructure Management Capability provides managed services for clients' IT infrastructure globally. It offers server, network, security and application management as well as virtualization, desktop, cloud management and other services. It has expertise across various technologies including Microsoft, Linux, networking and security products. It aims to improve clients' ROI, reduce costs and risks through flexible scalable support delivered using mature processes.
This document discusses bridging the gap between agile delivery and IT operations. It identifies quality, automation, and portability as keys to achieving this. Quality is important for the developer and operations relationship. Automation allows for continuous testing, faster feedback, and more stable releases. Portability ensures consistent auto-deployment across environments like development, testing, staging and production both on-premise and in various cloud vendors.
Calibration Excellence: Intelligent Application of Smart Technology is Just t...Emerson Exchange
Presented by GSK's Don Brady and Emerson's Richard Barnes at the 2011 Emerson Exchange conference in Nashville, TN USA.
Abstract: The project for an innovative integrated PlantWeb asset and calibration management solution went live in Nov 2010 at GSK’s Cork facility, a primary API production plant. This workshop presents GSK’s Calibration Excellence program and the significant improvements in business operations and management of regulatory compliance that it is delivering in support of GSK’ s world class manufacturing program. This system forms part of the GSK global engineering strategy.
The author has received the GSK Excellence Recognition Award in acknowledgement of the importance and success of this project.
The document discusses success factors for cloud/SaaS product delivery including:
1) Using agile project management principles like short release cycles and test-driven development.
2) Ensuring high code quality through techniques like continuous integration, regression testing, and code quality analysis on nightly builds.
3) Adhering to stringent service level agreements by automating performance and scalability testing with each release build.
This document provides an overview of Oracle SOA Suite 11g and its key features and benefits. It discusses how SOA Suite 11g enables simplified and productive development with features like the SOA composite editor. It also describes how SOA Suite 11g provides a unified platform for integrating services, events, and processes. Additionally, it outlines how SOA Suite 11g offers unified management and monitoring capabilities as well as extreme performance and scalability through technologies like Oracle WebLogic Server, Oracle Coherence, and Oracle JRockit. The document provides examples of how specific 11g features address challenges in areas like end-to-end visibility, security, and infrastructure optimization.
This Presentation gives a snapshot of Gateway\'s Remote IT infrastructure Management Division and its capabilities around various Services of Network, Server, IT Security Infrastructure and desktop / help desk support services.
A medical device company implemented an electronic medical device reporting (eMDR) system within their existing TrackWise quality management system to streamline regulatory reporting and compliance. RCM helped identify gaps between the current complaints process and eMDR requirements, configured changes to the TrackWise system, and validated the new eMDR workflow. The project was completed on time and on budget, allowing the company to reduce costs associated with medical device reporting through an automated, rules-based system.
National Australia Bank is developing its internal cloud capability and has been a member of the Open Data Center Alliance (ODCA) steering committee since 2010. The ODCA aims to drive adoption of cloud computing through common standards that promote security, interoperability, and transparency. NAB participates in the ODCA to help build capability, provide industry experience, and engage its employees. The ODCA works to define requirements that encourage cloud providers to deliver solutions aligned with enterprises' needs as they progress along a Cloud Maturity Model from 2010 to 2016.
Core Network Optimization: The Control Plane, Data Plane & BeyondRadisys Corporation
This presentation takes you through the challenges network operators are facing as they bring in more and more bandwidth-intensive applications to their network. There are ways to optimize the network from the RAN to the Core -- and improve QoS.
This document provides an overview of the Content Management Interoperability Services (CMIS) and Java Content Repository (JCR) standards. It introduces CMIS as a specification for interoperability between document management systems, compares it to JCR which defines a content repository model and Java API, and outlines the history and status of both standards. CMIS 1.0 has been released as a baseline, while JCR 2.0 adds new features like improved querying and is finishing development. The two standards are described as complementary with CMIS focusing on document management interoperability and JCR providing a more general purpose content repository infrastructure.
IBM Smarter Business 2012 - Du behöver inte sikta mot stjärnorna för att komm...IBM Sverige
Många har startat sin resa mot att kunna leverera molntjänster internt. Mycket energi har gått åt till att konsolidera och virtualisera, men sedan då? Vad ska man sedan göra? Vi diskuterar vad som behöver göras för att kunna leverera och konsumera molntjänster med högsta möjliga kvalitet och effektivitet.
Talare: Monica Cleaeson, Executive Consultant, WW Cloud Tiger Team, IBM
Besök http://smarterbusiness.se för mer information.
LiveAction software provides complete capabilities for managing Cisco QoS implementations through the entire lifecycle. It offers:
1. Baselining and auditing of existing QoS policies before starting a project.
2. Monitoring of QoS performance and effectiveness in real-time and historically.
3. Troubleshooting to quickly find and fix problems when running real-time and mission-critical services.
It provides a graphical interface for creating, editing, deploying, and maintaining QoS policies based on Cisco best practices.
1. Full Service
25
CRO
YEARS
Accelerating Pharma time-to-market, cost effectively Track Record
Clinical data management
Asia Europe Americas
Clinical data management capability
1
2. Full Service
25
CRO
Overview of CDM services YEARS
Track Record
• Project management
• Protocol review
• CRF design
• Database design
• CRF tracking
• Data entry
• Data management plan
• Data validation specifications
• Discrepancy management
• Query generation
• Laboratory data management
• SAE reconciliation
• Electronic data transfer
2
3. Full Service
25
CRO
IT Infrastructure YEARS
Track Record
High quality Service High quality Service Compliance to SOP and
Delivery Support Delivery regulation
CDM Central Lab Medical Writing
Services
Pharmacovigilance BA/BE Statistical Analysis
Clinone/
OC OC RDC MedDRA WHO DD DMS SAS STARLIMS
Application ARK
Business Applications are in 3 tier architecture & deployed in test and production environment separately
Cisco Routers/ Scalable & High capacity Qualified &
Windows Oracle / SQL SAN
Infrastructure Switches/ Structured B/W internet & Trained
OS Database Storage
Firewall Network WAN links People
Quality &
Standards ISO 9001, ISO 27001, CSV, 21 CFR PART 11 Compliance, IT Policies & SOPs
3
4. Full Service
25
CRO
CDSM platform deployed by Infosys YEARS
Track Record
• Oracle 4.5.3 with RDC
• TMS 4.6 integrated with WHO-DDE and MedDRA dictionaries
• SAS 9.2
• Deployed in 3 environments, test, development and production with 3 tier architecture
• Database server is on UNIX OS for high availability
• Sized to take high volumes
• Validated as per CSV lifecycle with IQ, OQ and PQ
• System compliant to 21 CFR PART 11 and audited by Lachman Associates
• Annotations are done as per CDISC convention/sponsor specific
• SOPs in line with GCDMP and ICH GCP standards and recommendations
• Stability is time tested with 54 projects handled through current system
Mature CDM system with proven performance
4
5. Full Service
25
CRO
Data Security Policy & Disaster Recovery Plan
21 CFR Part 11 compliant, security controls follow ISO 27001 standards YEARS
Track Record
Data Security Policy Disaster Recovery Plan
• Secure data center with biometric access control & Enterprise wide disaster recovery plan (SOP) to
surveillance camera take care of business continuity in case of natural
• IT policies for password management, shared calamities and disasters
resources, end-point security BCPs to take care of any circumstance of non
• Antivirus, content /URL/spam filtering system, and availability of business critical applications
network monitoring systems
Replication of database archival logs to different
• Perimeter firewall prevents unauthorized access. location for restoring data up to latest transaction
High level encryption compatible
Backup & restore policies with written RPO and
• Data transfer of secure FTP, secure email thru site-
RTO
to-site VPN/Internet
• Role based access for all the applications Mock testing of backup restore procedures on
regular basis
Data Backup
Online backup system with tape library
Daily incremental backup and weekly full backup
Onsite storage of data tapes in fireproof data safe and offsite storage with archival agency
5
6. Full Service
25
CRO
Experience and resources YEARS
Track Record
FUNCTION EXPERIENCE STAFF IN STAFF IN Σ
EUROPE INDIA
Data management Up to 8 years 1 6 7
programmer
Data manager Up to 15 years 3 12 15
Clinical data associate Up to 3 years 5 6 11
Database administrator Up to 8 years 2 1 3
Biostatistician Up to 28 years 2 8 10
Statistical programmer Up to 15 years 4 5 9
Medical writer / coder Up to 20 years 2 13 15
Σ 19 51 70
Deep domain experience both in Europe and India
6
7. Full Service
25
CRO
CDM Team
YEARS
Track Record
Data managers Database administrator
Database
programmers
Clinical data associates
Medical coder
Biostatistician /
SAS programmer
This team is led by highly qualified leaders with deep domain experience
Qualified in medicine, pharmacy, biotech or IT & experience in CDM
8. Full Service
25
CRO
Project management –Communication channel YEARS
Can set up project management between Europe, Asia and USA Track Record
STAT
SITES
CRL
DM Programmer
PDM
PM Data Manager
Clin Data Assoc
Medical Coders
SPONSOR QA
8
9. Full Service
25
CRO
CDM workflow YEARS
Workflow & process built around globally accepted practice Track Record
Study setup CRF annotation
•CDISC compatible
• Resource allocation CRF Designing DB design & validation
•Sponsor specific
• Project plan
• Training
Data management plan Prg of validation checks
DATABASE LIVE
BV
CRF data Data entry Data validation
•Receipt and tracking
•Control and storage
Paper -CRF • Discrepancy management
Non- CRF data
Query generation &
Medical coding
Database lock resolution Quality control
Statistical analysis SAE reconciliation
9
10. Full Service
25
CRO
RDC Project Execution & Delivery Process (1/2)
YEARS
Track Record
EA Project Management Team
Escalation
Sponsor
EDC
Country Project Manager 1
System;
Country Project Manager 2
Other OC RDC
Services
---------
4.5.3
----------
Country Project Manager 9
Database Design
Discrepancy Management
Quality Control, Database
Lock
CDM Team
Countries
RDC Helpdesk
Sites
Patients
10
11. Full Service
25
CRO
RDC Project Execution & Delivery Process (2/2)
YEARS
Track Record
• End-to-end clinical data management activities will be performed by trained and an experienced
team. Each functional representative on a team brings a unique set of experiences, skills, and
knowledge
• Data management activities performed will be compliant to the SOPs. QC process is implemented
to verify that processes and procedures have been followed including documentation
• The data management system used is OC RDC tool which is stable, 21 CFR PART 11 Compliant
and web based application hosted in MAL data center on high capacity servers.
• The study database is validated prior to the start of live data entry.
• A well defined Data Management Plan is prepared which defines the scope of work,
responsibilities, communication plan, description of the various data management activities
performed, timelines, Quality and regulatory standards to be met and how they will be achieved,
Communication plan , Applicable processes and SOPs including project specific processes and
procedures
– Prior to database lock, the QC of all the critical data points is performed and a final inspection is
performed on all the data points of the sample size subjects. The database is audited for accuracy
and completeness
• Regular updates is provided to the sponsors at regular intervals in the form of status reports
• Communication channel between the sponsor and the CRO will be clearly defined at the
beginning of the study
11
12. Full Service
25
CRO
Electronic data capture system build workflow
(including but not limited to) YEARS
Track Record
12
13. Full Service
Data Entry and Discrepancy Management in in RDC 25
CRO
YEARS
Track Record
Data entered by site
staff
System-generated Discrepancy closed
Site staff correct
by system, CRA or
discrepancies eCRF
DM
Changes
rejected
Validation Site staff correct CRA reviews
eCRF or comment changes or CRA performs SDV
Checks on entered data comments
Investigator
approves eCRF CRA verifies eCRF
Casebook
13
14. Full Service
25
CRO
RDC Work Flow Diagram (for a complete study) YEARS
Track Record
FPI LPO
Protocol
Review
CRF DB Design Edit Checks RDC Training for DB Maintenance DB
Review & Validation programming Site Personnel Closure
External Data
Definition
Discrepancy
Management
Site Provisioning
14
15. Full Service
25
CRO
Performance - Quality measures YEARS
Track Record
DB lock checklist Clinical
DB lock study report
100% check
Quality control is applied to each stage of Statistical of numbers,
data handling driven by SOP to ensure that analysis: check of
all data are reliable and have been Double pro- statements
processed and reported correctly. gramming,
Blind
table check
data
QA- CRF to review
Programmed & database
manual checks, inspection
clean and
Double dirty dummies
Finalize DB CRF data entry
structure on tracking
System full dummy
validation extract
by CSV
team
GCDMP, ICH GCP & FDA 21CFR Part 11 followed in the process
15
16. Full Service
25
CRO
CDM experience- India since 2005
Wide therapeutic experience and consistent growth YEARS
Track Record
Oncology, 9, Respiratory, 13,
15% 21%
NSAID, 1, 2%
Neurology, 3, 4%
Musculoskeletal, Nutrition, 1, 2%
3, 5%
Gastroenterolog Ophthalmology,
y, 4, 7% 7, 11%
Endocrinology,
5, 8% N = 61
Dermatology, 3, Cardiology, 12,
5% 20%
Year 2005 2006 2007 2008 2009 2010 2011
No. of Studies 3 13 9 8 16 5 7
No. of CRF pages 107 6589 57642 65214 31230 73003 24346
handled
16
17. Full Service
25
CRO
Flexible service delivery models
YEARS
Track Record
India
EU Experience, India advantage
40
No. of trials
30
PM in PM in PM in
38 Frankfurt Bangalore Frankfurt
20
23 Conduct Conduct in Conduct in
10
in FFM BLR BLR & FFM
0
Standalone End to end
Europe
Deliver
quality data
speedily
at
competitive
cost
&
personalized
service
18. Full Service
25
CRO
Contact us www.ecronacunova.com YEARS
Track Record
We accelerate Pharma time-to-market cost effectively
ASIA EUROPE AMERICAS
SJR I Park, Mobius Hahnstrasse 70 502 Carnegie Center
EPIP, Whitefield D-60528 Suite # 100 Princeton
Bangalore – 560 066 Frankfurt NJ 08540,
India Germany USA
bdasia@ecronacunova.com bdeurope@ecronacunova.com bdamericas@ecronacunova.com
+91 80 6691 5787 +49 69 6680300 +1 973 396 2742
Thank You
18