The Expanding eClinical Universe: Streamlining Progress by Changing Current Work Processes and Moving Away from Paper Alan S. Louie, Ph.D., Research Director, IDC Health Insights
The document discusses how clinical trials are moving from paper-based processes to electronic systems to improve efficiency. It highlights trends like increased adoption of electronic data capture systems and clinical trial management systems. The clinical trials IT ecosystem is becoming more interconnected through technologies that provide better data access, analytics, and responsiveness to potential drug safety issues. Vendors are offering more comprehensive eClinical solutions through hosted systems and software-as-a-service models. This transformation aims to streamline work processes and address challenges like rising costs in global clinical trials.
1. Bio-Modeling Systems (BMS) is a biotech company that creates CADI models to accelerate life sciences research and discoveries for clients.
2. CADI models are detailed maps of inter-cellular and intra-cellular mechanisms associated with biological states that can describe disease processes without using mathematics.
3. BMS generates revenue by applying CADI models to research programs for pharmaceutical, biotech, chemical and other industries, helping to identify new targets, biomarkers, and therapeutic strategies more quickly and at lower cost.
TAKE provides business solutions and services for the life sciences industry to help companies address challenges from increasing regulations and competition. They offer deep domain expertise, technology solutions, and business services across clinical development, regulatory, safety, and enterprise IT functions. This includes strategy consulting, data services, analytics, and application management. TAKE aims to help life sciences companies comply with regulations while remaining competitive through a unified approach combining strategic advice with efficient operations.
The Phase Forward advantage provides access to clinical trial data in real-time and allows data analysis to begin almost immediately after the last patient visit. The modular functionality of Clintrial addresses both specific user requirements and broader organizational needs through an easy-to-use system that improves data quality, reduces drug development timelines and costs.
This document discusses model-based engineering approaches used by Siemens Healthcare in developing medical device software. It identifies challenges such as ambiguous specifications, complex architectures, and lack of verification and validation efficiency. Siemens addresses these issues through solutions like a requirements engineering meta-model to provide structure and traceability between business needs and technical specifications. They also use feature models and graphical clinical workflow models to improve understanding, scoping, and impact analysis for large projects. The aim is to increase efficiency, quality and productivity in medical device development.
Software-intensive medizinische Systeme stehen in einem immensen Marktdruck. Während sie technologisch und hinsichtlich ihrer Sicherheit kompromisslos innovativ sein müssen, fordern die Krankenhäuser und auch Gesundheitskostenreformen eine immer kürzere Zykluszeit bei gleichzeitig angespannten Budgets. Traditionelle Entwicklungsprozesse, die Innovation und Qualität über einen schwerfälligen Prozess erreichten, sind nicht mehr zeitgemäß. Unsere Studien zeigen, dass in der Medizintechnik die Kosten für Nacharbeiten über den Produktlebenszyklus hinweg durch eine Verbesserung des Requirements Engineering um 30-50% gesenkt werden können. Requirements Engineering hat daher eine Schlüsselstelle als Erfolgsfaktor im Gesundheitswesen. Modellbasierte Vorgehensweisen unterstützt die durchgängige Entwicklung von Anforderungen bis zur Validierung. Durch den erhöhten Abstraktionsgrad zu Beginn bei der anforderungsentwicklung und Analyse sind Problembeschreibungen wesentlich klarer, einfacher und weniger redundant. Das erhöht nicht nur die Entwicklungsgeschwindigkeit, sondern sorgt innerhalb des Projektes für klar verstandende Domänenkonzepte. Modelle helfen bei der Durchgängigkeit von den systemanforderungen zu den Softwareanforderungen und dann zu Design und Validierung. Unser Beitrag zeigt Industrieerfahrungen bei Siemens Healthcare und bietet Orientierung bei der Umsetzung modellbasierter Entwicklung mit Fokus auf Requirements Engineering in medizinischen Systemen. Wir zeigen, wie Anforderungen so formalisiert werden, dass einerseits informell formulierte Anforderungen schrittweise in eine formalere Form kommen und während die Verständlichkeit der Anforderungen erhalten bleibt. Damit sind die Anforderungen präzise formuliert und werden zur Konsistenzsicherung und Vervollständigung genutzt, und sie können weiterhin von Stakeholder verschiedenem Hintergrund verstanden und validiert werden.
This document discusses the importance of data quality in clinical trials and the use of MedDRA for coding clinical trial data. It provides an overview of MedDRA and outlines best practices for coding clinical data to ensure accurate analysis and safety signal detection. High quality input data is emphasized as it directly impacts the quality of outputs and analysis. Challenges in coding ambiguous or vague data are also explored.
The Leading Edge Group has over 15 years of experience implementing Lean and supply chain optimization solutions globally. They provide customized training, education, and consulting services, including an online toolkit. Their integrated Lean solutions are delivered through white belt to black belt programs for both individuals and organizations. The Leading Edge Group partners with top academic and industry organizations and is led by Lean experts with a proven track record of success.
1. Bio-Modeling Systems (BMS) is a biotech company that creates CADI models to accelerate life sciences research and discoveries for clients.
2. CADI models are detailed maps of inter-cellular and intra-cellular mechanisms associated with biological states that can describe disease processes without using mathematics.
3. BMS generates revenue by applying CADI models to research programs for pharmaceutical, biotech, chemical and other industries, helping to identify new targets, biomarkers, and therapeutic strategies more quickly and at lower cost.
TAKE provides business solutions and services for the life sciences industry to help companies address challenges from increasing regulations and competition. They offer deep domain expertise, technology solutions, and business services across clinical development, regulatory, safety, and enterprise IT functions. This includes strategy consulting, data services, analytics, and application management. TAKE aims to help life sciences companies comply with regulations while remaining competitive through a unified approach combining strategic advice with efficient operations.
The Phase Forward advantage provides access to clinical trial data in real-time and allows data analysis to begin almost immediately after the last patient visit. The modular functionality of Clintrial addresses both specific user requirements and broader organizational needs through an easy-to-use system that improves data quality, reduces drug development timelines and costs.
This document discusses model-based engineering approaches used by Siemens Healthcare in developing medical device software. It identifies challenges such as ambiguous specifications, complex architectures, and lack of verification and validation efficiency. Siemens addresses these issues through solutions like a requirements engineering meta-model to provide structure and traceability between business needs and technical specifications. They also use feature models and graphical clinical workflow models to improve understanding, scoping, and impact analysis for large projects. The aim is to increase efficiency, quality and productivity in medical device development.
Software-intensive medizinische Systeme stehen in einem immensen Marktdruck. Während sie technologisch und hinsichtlich ihrer Sicherheit kompromisslos innovativ sein müssen, fordern die Krankenhäuser und auch Gesundheitskostenreformen eine immer kürzere Zykluszeit bei gleichzeitig angespannten Budgets. Traditionelle Entwicklungsprozesse, die Innovation und Qualität über einen schwerfälligen Prozess erreichten, sind nicht mehr zeitgemäß. Unsere Studien zeigen, dass in der Medizintechnik die Kosten für Nacharbeiten über den Produktlebenszyklus hinweg durch eine Verbesserung des Requirements Engineering um 30-50% gesenkt werden können. Requirements Engineering hat daher eine Schlüsselstelle als Erfolgsfaktor im Gesundheitswesen. Modellbasierte Vorgehensweisen unterstützt die durchgängige Entwicklung von Anforderungen bis zur Validierung. Durch den erhöhten Abstraktionsgrad zu Beginn bei der anforderungsentwicklung und Analyse sind Problembeschreibungen wesentlich klarer, einfacher und weniger redundant. Das erhöht nicht nur die Entwicklungsgeschwindigkeit, sondern sorgt innerhalb des Projektes für klar verstandende Domänenkonzepte. Modelle helfen bei der Durchgängigkeit von den systemanforderungen zu den Softwareanforderungen und dann zu Design und Validierung. Unser Beitrag zeigt Industrieerfahrungen bei Siemens Healthcare und bietet Orientierung bei der Umsetzung modellbasierter Entwicklung mit Fokus auf Requirements Engineering in medizinischen Systemen. Wir zeigen, wie Anforderungen so formalisiert werden, dass einerseits informell formulierte Anforderungen schrittweise in eine formalere Form kommen und während die Verständlichkeit der Anforderungen erhalten bleibt. Damit sind die Anforderungen präzise formuliert und werden zur Konsistenzsicherung und Vervollständigung genutzt, und sie können weiterhin von Stakeholder verschiedenem Hintergrund verstanden und validiert werden.
This document discusses the importance of data quality in clinical trials and the use of MedDRA for coding clinical trial data. It provides an overview of MedDRA and outlines best practices for coding clinical data to ensure accurate analysis and safety signal detection. High quality input data is emphasized as it directly impacts the quality of outputs and analysis. Challenges in coding ambiguous or vague data are also explored.
The Leading Edge Group has over 15 years of experience implementing Lean and supply chain optimization solutions globally. They provide customized training, education, and consulting services, including an online toolkit. Their integrated Lean solutions are delivered through white belt to black belt programs for both individuals and organizations. The Leading Edge Group partners with top academic and industry organizations and is led by Lean experts with a proven track record of success.
Bayesian reliability demonstration test in a design for reliability processASQ Reliability Division
This document discusses Bayesian reliability demonstration tests (BRDT) in the design for reliability (DFR) process. It presents challenges with traditional reliability demonstration tests, and how BRDT can help address these challenges by incorporating prior knowledge of a product's reliability from DFR activities. The document outlines how BRDT uses Bayesian statistics with a prior reliability distribution, typically Beta, to calculate posterior reliability and determine confidence levels. It proposes a simplified BRDT algorithm for DFR that constructs the prior reliability distribution based on DFR inputs then performs trade-off studies to determine test parameters like sample size. BRDT allows testing with smaller sample sizes by leveraging reliability information from the DFR process.
The marketing challenges of customized ablationSM2 Strategic
Customized ablation using wavefront technology presents new marketing challenges for refractive surgeons. While it offers improved outcomes, it also increases complexity and costs. Surgeons will need to shift their perspective from viewing other surgeons as competitors to focusing on meeting patient needs. Emphasizing increased safety perceptions and contextualizing customized ablation within the history of refractive developments can help maximize its potential to expand the surgical category and drive demand. Good customer service that enhances perceived value beyond the technology itself will also be important for success.
Benchmark METRICS THAT MATTER October 4 2012BenchmarkQA
Betty Schaar and Jeff Roth presented this at BenchmarkQA's fall 2012 Software Quality Forum, challenging attendees to rethink the metrics they're generating. Metrics without the context of the project mean nothing.
This document summarizes John Hammergren's presentation at the Bear Stearns Global Healthcare Conference on September 14, 2004. The presentation provides an overview of McKesson Corporation, including who they are, their view of the healthcare industry, and how their businesses are responding to current challenges. Key highlights discussed include McKesson's strong financial performance, their strategy to fundamentally change healthcare costs and quality through technology and partnerships, and growth in their pharmaceutical distribution business.
Six Sigma is a data-driven methodology for process improvement that can help address key challenges in hospital operations like quality, costs and efficiency. It aims for near perfect quality levels. The document discusses how Six Sigma was used in a case study to reduce catheter-related bloodstream infections in an ICU from 4 to 0 infections per month. It also outlines the typical Six Sigma infrastructure and roles, and how Six Sigma can be applied to different areas of hospital services and operations.
Creating Value Through Computable Clinical DataRobert Bond
Computable clinical data has numerous high value applications including comparative effectiveness research, personalized medicine, and claims adjudication. I discuss some of the technologies involved in making patient data computable
The document provides an overview of Agilent, a measurement company with $4.5 billion in annual revenue. It details Agilent's business segments, market focus in electronic measurement and bio-analytical measurement, key customers, strategies for growth, and commitment to quality, citizenship, and environmental stewardship.
The document summarizes Session III of a conference on pre-clinical proof-of-concept and development. It includes presentations on:
1. Edward Spack discussing the session overview and requirements for an Investigational New Drug (IND) application.
2. David Weiner presenting on what makes a clinical candidate, including factors like target selection, lead optimization, pre-clinical safety assessments, and estimating human starting doses.
3. Steve Perrin presenting on optimization and characterization of mouse models of neurodegeneration.
4. Barry Greenberg presenting on the value of biomarkers in preclinical development and translatable endpoints.
Medical Device Development - Automating Traceability and DocumentationSeapine Software
The document summarizes the key requirements and challenges for automating compliant product development in the medical device industry. It outlines core FDA regulations on design control, documentation, and reporting that companies must follow. It also discusses challenges like information overload, difficulty tracking changes, and disconnects between groups. The document proposes an ideal automated solution that provides traceability, workflow integration, and helps companies focus on innovation while meeting compliance. It concludes by discussing the need to document the ideal solution, gain management support, and select the right technology.
Agilent Technologies is an American company that focuses on measurement solutions across electronic measurement, chemical analysis, and life sciences. In fiscal year 2011, Agilent generated $6.6 billion in revenue, with over 70% coming from outside the US. The company operates across 100+ countries and has 18,700 employees. Agilent leads the industry in electronic measurement, chemical analysis of food and energy, and life sciences tools for research and manufacturing.
Healthcare and Life Sciences - Cloud ComputingMike Watson
Cloud computing offers healthcare and life sciences companies new opportunities for collaboration, innovation, and efficiency. It allows for vast amounts of data to be securely stored and shared, flexible infrastructure for research needs, and common business processes across organizations. This transforms industries by enabling new models like precision medicine through large-scale analytics and more agile product development through testing and trials in the cloud.
- Planet Metrics is a 10 person company founded in 2007 that provides sustainability analysis software to measure embodied energy and carbon across supply chains.
- The software helps companies assess risks like climate change and commodity prices, identify inefficiencies, and innovation opportunities to support corporate sustainability strategies and long-term financial performance.
- It provides a hybrid environmental database with tools for data management, simulation, and information visualization to analyze sustainability performance and collaborate on metrics.
Resorcetek Systems Pvt Ltd is an IT services company established in 2008 that provides quality and cost-effective solutions primarily to healthcare and related industries. It employs experienced professionals and focuses on application development, strategic outsourcing, and technology consulting. The company's goals include adhering to high international standards and primarily serving the healthcare sector and a few other related verticals.
There’s so much great science buried in your Research and Clinical data. Our Informatics solutions connect all your disparate islands of information. This is how unconnected data becomes smart data.
Game of documentation, Winter is coming Surviving ICD10Nick van Terheyden
The document provides an overview of ICD-10 implementation and the impact of clinical documentation on outcomes and reimbursement. It discusses how accurate documentation is important for determining severity of illness and risk adjustment, which drives hospital reimbursement and quality metrics. It emphasizes that physicians need to fully document their clinical decision making to avoid issues like payment denials, penalties, or inaccurate performance assessments that could arise from incomplete records.
This document discusses leveraging technology to advance clinical documentation improvement (CDI) programs. It notes that current CDI programs focus primarily on revenue cycle management and have resulted in physician cynicism. The document advocates for more physician-engaged CDI programs that integrate with quality initiatives and utilize technology like computer-assisted physician documentation (CAPD) to provide real-time guidance to physicians. This could help address challenges under ICD-10 by capturing accurate clinical impressions and ensuring compliant documentation. The document concludes that successful CDI programs require advanced, clinically integrated technologies that fit with physician workflows.
Social Media Round Table: How to Make Social Media Work for YouJenniferTen22
This document outlines tips for making social media work for your career and professional brand. It recommends building your online profiles, securing endorsements, joining conversations, and participating in groups on platforms like LinkedIn, Twitter and blogs. Doing so can help you improve your searchability, networking opportunities, learning and experiences at conferences. Specific actions highlighted include updating profiles, following others, participating in chats, and blogging regularly while keeping content professional. Balancing personal and professional use and finding time for social media are common challenges also addressed.
The document discusses a panel at the 2013 Annual Physician-Computer Connection Symposium on the future of clinical documentation. The panelists were from Accenture, Nuance, Precyse, and M*Modal. Key points from the published "American Medical Directors of Information Systems Consensus on Inpatient Electronic Health Record Documentation" included optimizing EHR note functionality, identifying coded diagnoses, keeping privacy in mind, focusing on note quality over excessive details, and limiting copy and pasting. The panel discussed how medical education needs to model best documentation practices and considered what might come after current paper, smarttext, voice typing, and dictation methods.
The document discusses the future of clinical documentation and the need to expand the current physician notes paradigm to support care coordination and the team care model. It notes that achieving care coordination is key to realizing the Triple Aim and that the current notes are not adequate. The notes need to include clinician colleagues, patients, and outcomes of the care plan. It also addresses principles of clinical documentation and the need to support care coordination through documentation during transitions of care.
Building Data Driven Workflows in HIM: More than just an EHRJenniferTen22
You'll gain a deeper understanding of EHR’s data demands and clinical intelligence limitations by understanding how NLP harmonizes clinical information, structured and unstructured.
Reid F. Conant, MD, FACEP, Senior Physician Advocate, on Physician Documentation & the results of driving data capture with Dragon Medical 360 | Network Edition. Want to know more? www.nuance.co.uk/for-healthcare
Shape your ICD-10 Technology Strategy: Be Ready for Change and Protect Revenueoptum
This document discusses strategies for hospitals to prepare for the transition to ICD-10 coding. It provides an overview of ICD-10, highlights key impact areas for hospitals, and risks around productivity and reimbursement. It then presents a three-phase model project plan for hospitals to investigate impacts, innovate processes, and implement changes. New technologies like computer-assisted coding are spotlighted as ways to support the transition by helping coders and improving documentation. The document concludes with a case study showing benefits some hospitals achieved through implementing computer-assisted coding, including increased coder productivity, accuracy, and cost savings.
Bayesian reliability demonstration test in a design for reliability processASQ Reliability Division
This document discusses Bayesian reliability demonstration tests (BRDT) in the design for reliability (DFR) process. It presents challenges with traditional reliability demonstration tests, and how BRDT can help address these challenges by incorporating prior knowledge of a product's reliability from DFR activities. The document outlines how BRDT uses Bayesian statistics with a prior reliability distribution, typically Beta, to calculate posterior reliability and determine confidence levels. It proposes a simplified BRDT algorithm for DFR that constructs the prior reliability distribution based on DFR inputs then performs trade-off studies to determine test parameters like sample size. BRDT allows testing with smaller sample sizes by leveraging reliability information from the DFR process.
The marketing challenges of customized ablationSM2 Strategic
Customized ablation using wavefront technology presents new marketing challenges for refractive surgeons. While it offers improved outcomes, it also increases complexity and costs. Surgeons will need to shift their perspective from viewing other surgeons as competitors to focusing on meeting patient needs. Emphasizing increased safety perceptions and contextualizing customized ablation within the history of refractive developments can help maximize its potential to expand the surgical category and drive demand. Good customer service that enhances perceived value beyond the technology itself will also be important for success.
Benchmark METRICS THAT MATTER October 4 2012BenchmarkQA
Betty Schaar and Jeff Roth presented this at BenchmarkQA's fall 2012 Software Quality Forum, challenging attendees to rethink the metrics they're generating. Metrics without the context of the project mean nothing.
This document summarizes John Hammergren's presentation at the Bear Stearns Global Healthcare Conference on September 14, 2004. The presentation provides an overview of McKesson Corporation, including who they are, their view of the healthcare industry, and how their businesses are responding to current challenges. Key highlights discussed include McKesson's strong financial performance, their strategy to fundamentally change healthcare costs and quality through technology and partnerships, and growth in their pharmaceutical distribution business.
Six Sigma is a data-driven methodology for process improvement that can help address key challenges in hospital operations like quality, costs and efficiency. It aims for near perfect quality levels. The document discusses how Six Sigma was used in a case study to reduce catheter-related bloodstream infections in an ICU from 4 to 0 infections per month. It also outlines the typical Six Sigma infrastructure and roles, and how Six Sigma can be applied to different areas of hospital services and operations.
Creating Value Through Computable Clinical DataRobert Bond
Computable clinical data has numerous high value applications including comparative effectiveness research, personalized medicine, and claims adjudication. I discuss some of the technologies involved in making patient data computable
The document provides an overview of Agilent, a measurement company with $4.5 billion in annual revenue. It details Agilent's business segments, market focus in electronic measurement and bio-analytical measurement, key customers, strategies for growth, and commitment to quality, citizenship, and environmental stewardship.
The document summarizes Session III of a conference on pre-clinical proof-of-concept and development. It includes presentations on:
1. Edward Spack discussing the session overview and requirements for an Investigational New Drug (IND) application.
2. David Weiner presenting on what makes a clinical candidate, including factors like target selection, lead optimization, pre-clinical safety assessments, and estimating human starting doses.
3. Steve Perrin presenting on optimization and characterization of mouse models of neurodegeneration.
4. Barry Greenberg presenting on the value of biomarkers in preclinical development and translatable endpoints.
Medical Device Development - Automating Traceability and DocumentationSeapine Software
The document summarizes the key requirements and challenges for automating compliant product development in the medical device industry. It outlines core FDA regulations on design control, documentation, and reporting that companies must follow. It also discusses challenges like information overload, difficulty tracking changes, and disconnects between groups. The document proposes an ideal automated solution that provides traceability, workflow integration, and helps companies focus on innovation while meeting compliance. It concludes by discussing the need to document the ideal solution, gain management support, and select the right technology.
Agilent Technologies is an American company that focuses on measurement solutions across electronic measurement, chemical analysis, and life sciences. In fiscal year 2011, Agilent generated $6.6 billion in revenue, with over 70% coming from outside the US. The company operates across 100+ countries and has 18,700 employees. Agilent leads the industry in electronic measurement, chemical analysis of food and energy, and life sciences tools for research and manufacturing.
Healthcare and Life Sciences - Cloud ComputingMike Watson
Cloud computing offers healthcare and life sciences companies new opportunities for collaboration, innovation, and efficiency. It allows for vast amounts of data to be securely stored and shared, flexible infrastructure for research needs, and common business processes across organizations. This transforms industries by enabling new models like precision medicine through large-scale analytics and more agile product development through testing and trials in the cloud.
- Planet Metrics is a 10 person company founded in 2007 that provides sustainability analysis software to measure embodied energy and carbon across supply chains.
- The software helps companies assess risks like climate change and commodity prices, identify inefficiencies, and innovation opportunities to support corporate sustainability strategies and long-term financial performance.
- It provides a hybrid environmental database with tools for data management, simulation, and information visualization to analyze sustainability performance and collaborate on metrics.
Resorcetek Systems Pvt Ltd is an IT services company established in 2008 that provides quality and cost-effective solutions primarily to healthcare and related industries. It employs experienced professionals and focuses on application development, strategic outsourcing, and technology consulting. The company's goals include adhering to high international standards and primarily serving the healthcare sector and a few other related verticals.
There’s so much great science buried in your Research and Clinical data. Our Informatics solutions connect all your disparate islands of information. This is how unconnected data becomes smart data.
Game of documentation, Winter is coming Surviving ICD10Nick van Terheyden
The document provides an overview of ICD-10 implementation and the impact of clinical documentation on outcomes and reimbursement. It discusses how accurate documentation is important for determining severity of illness and risk adjustment, which drives hospital reimbursement and quality metrics. It emphasizes that physicians need to fully document their clinical decision making to avoid issues like payment denials, penalties, or inaccurate performance assessments that could arise from incomplete records.
This document discusses leveraging technology to advance clinical documentation improvement (CDI) programs. It notes that current CDI programs focus primarily on revenue cycle management and have resulted in physician cynicism. The document advocates for more physician-engaged CDI programs that integrate with quality initiatives and utilize technology like computer-assisted physician documentation (CAPD) to provide real-time guidance to physicians. This could help address challenges under ICD-10 by capturing accurate clinical impressions and ensuring compliant documentation. The document concludes that successful CDI programs require advanced, clinically integrated technologies that fit with physician workflows.
Social Media Round Table: How to Make Social Media Work for YouJenniferTen22
This document outlines tips for making social media work for your career and professional brand. It recommends building your online profiles, securing endorsements, joining conversations, and participating in groups on platforms like LinkedIn, Twitter and blogs. Doing so can help you improve your searchability, networking opportunities, learning and experiences at conferences. Specific actions highlighted include updating profiles, following others, participating in chats, and blogging regularly while keeping content professional. Balancing personal and professional use and finding time for social media are common challenges also addressed.
The document discusses a panel at the 2013 Annual Physician-Computer Connection Symposium on the future of clinical documentation. The panelists were from Accenture, Nuance, Precyse, and M*Modal. Key points from the published "American Medical Directors of Information Systems Consensus on Inpatient Electronic Health Record Documentation" included optimizing EHR note functionality, identifying coded diagnoses, keeping privacy in mind, focusing on note quality over excessive details, and limiting copy and pasting. The panel discussed how medical education needs to model best documentation practices and considered what might come after current paper, smarttext, voice typing, and dictation methods.
The document discusses the future of clinical documentation and the need to expand the current physician notes paradigm to support care coordination and the team care model. It notes that achieving care coordination is key to realizing the Triple Aim and that the current notes are not adequate. The notes need to include clinician colleagues, patients, and outcomes of the care plan. It also addresses principles of clinical documentation and the need to support care coordination through documentation during transitions of care.
Building Data Driven Workflows in HIM: More than just an EHRJenniferTen22
You'll gain a deeper understanding of EHR’s data demands and clinical intelligence limitations by understanding how NLP harmonizes clinical information, structured and unstructured.
Reid F. Conant, MD, FACEP, Senior Physician Advocate, on Physician Documentation & the results of driving data capture with Dragon Medical 360 | Network Edition. Want to know more? www.nuance.co.uk/for-healthcare
Shape your ICD-10 Technology Strategy: Be Ready for Change and Protect Revenueoptum
This document discusses strategies for hospitals to prepare for the transition to ICD-10 coding. It provides an overview of ICD-10, highlights key impact areas for hospitals, and risks around productivity and reimbursement. It then presents a three-phase model project plan for hospitals to investigate impacts, innovate processes, and implement changes. New technologies like computer-assisted coding are spotlighted as ways to support the transition by helping coders and improving documentation. The document concludes with a case study showing benefits some hospitals achieved through implementing computer-assisted coding, including increased coder productivity, accuracy, and cost savings.
This document contains the resume of Fariba Fadaee. She has over 7 years of experience in clinical documentation and over 10 years practicing medicine. She has held various roles related to clinical documentation improvement and coding, including as a clinical documentation specialist, coding analyst, and CDS manager. She has extensive experience in physician education on topics like ICD-9, ICD-10, MS-DRGs, and quality reporting measures. She is proficient in various medical software programs and health records systems. Her education includes obtaining an MD in Iran and additional certifications in areas like coding, documentation, and health information technology.
Healthstory Enabling The Emr - Dictation To Clinical DataNick van Terheyden
EHRs are database centric while medical records are document centric. The conventional wisdom is that documents are bad and discrete data is good. Historically, clinicians have resisted efforts to establish structured data standards for dictated reports. This lack of an industry-wide standard for report content and format confounds interoperability efforts. For nearly two decades, information system specialists have attempted to impose new documentation methods that are more suited to database management but do not meet the needs of the practicing physician. Achieving physician buy-in for electronic record systems that do not accommodate narrative documentation methods such as dictation and transcription has proven to be quite difficult for many EHR vendors.
The Health Story Project (formerly the CDA4CDT initiative Clinical Document Architecture for Common Data Types) is an alliance of organizations that have been working together with HL7 for nearly two years to develop and publish data standards for electronic clinical documents. The initiative is based on Clinical Document Architecture (CDA) - a balloted HL7 document markup standard that specifies the structure and semantics of a clinical document for the purpose of exchange. Document templates for the most commonly dictated report types (H&P, Consult, Operative Note, etc) specify required and optional headings. Templates are developed based on prevailing practice and establish consensus on content and format
Healthstory Enabling The Emr - Dictation To Clinical Data
Similar to The Expanding eClinical Universe: Streamlining Progress by Changing Current Work Processes and Moving Away from Paper Alan S. Louie, Ph.D., Research Director, IDC Health Insights
Appalla Venkataprabhakar and I presented this at the Oracle\'s Annual Clinical Development and Safety Conference 2010 at Hyderabad, India on 6th October 2010.
Selecting Core Clinical It Solutions For Life Sciences Organizations – Key S...Vinoth Kumar T
This document summarizes a presentation on selecting core clinical IT solutions for life sciences organizations. It discusses the challenges life sciences companies face with drug development timelines and costs. Effective clinical data management can help address these challenges by streamlining processes, improving data quality and security, and enabling faster data review and regulatory submissions. When selecting clinical IT solutions, companies should evaluate vendors, ensure regulatory compliance, and consider costs, integration, usability, and ongoing support. A successful implementation requires understanding existing workflows, conducting pilots, addressing security risks, and having open communication channels to resolve problems.
Medical Imaging Seminar Company PresentationsSpace IDEAS Hub
Medical Imaging - Opportunities for Business Seminar
24/01/12
Short Company Presentations
14 companies took the opportunity to present a short sales pitch of their work and interests to the audience.
Event brochure for the upcoming Clinical Data Standardisation and Managment event in London, June.
The event will feature best practice case studies from CDISC
The document discusses the use of computers and technology in medicine. It covers topics like telemedicine, different medical imaging technologies like MRI, CT scans, mammography and ultrasound. It also discusses the importance of telemedicine in increasing access to healthcare and reducing costs, as well as some issues regarding telemedicine like the need for appropriate infrastructure and privacy concerns.
The document discusses Affinity Therapeutics' technology platform for developing microparticle formulations that provide extended local release of antibiotics to prevent surgical site infections. The company was founded in 2010 and is developing formulations to be used with hernia mesh repairs initially, with the goal of licensing the technology to medical device companies. The company has received an NIH Phase I SBIR grant and is working to negotiate licensing and facility agreements with universities.
Over the past few decades, medical science and its multiple domains have taken a quantum leap with the help of the latest technologies. The same applies for biometrics, that can be defined as a technology that helps in identification of individuals based on their physical and behavioral traits.
Pistoia presentation bio it-worldexpo 21april2010Nick Lynch
The document summarizes the origins and operations of the Pistoia Alliance, a non-profit organization formed to facilitate pre-competitive collaboration in the life sciences industry. The Pistoia Alliance was formed in Pistoia, Italy by GSK, AZ, Pfizer and Novartis to address common challenges with data interchange. Its mission is to standardize data exchange to reduce costs. Current projects include developing standards for semantic enrichment of literature, sequence data services, and electronic lab notebook queries. The organization has over 30 members and operates working groups to develop open standards through a governance process.
03 heemskerk eramind mobility mtg_trieste italy_fh_27_may10AREA Science Park
Frank Heemskerk presented on research mobility and commercialization. He discussed his background moving between academia and industry research. He emphasized the importance of networking and developing international partnerships between universities, research institutes, SMEs, and other organizations. Recommendations included improving communication between sectors, allowing flexibility in projects, and professionalizing research management to enable collaboration across borders.
In this presentation, you will learn how to transform a Big Data initiative into a realized, measurable ROI:
• Understand the complex mix of business expectation, hype, reality, and new information source opportunities in the Big Data space
• Use the Business Case process to help to you identify what you can achieve and what is not yet ready
• Build communities of interest around prototypes and plan for success for your company’s advantage
• Learn how to industrialize your Big Data innovations to achieve measurable, sustainable benefits
This document summarizes findings from a 2011 professional services study involving 450 participants. It shows that 56% of participants had engaged a professional services/consulting firm for clinical transformation, system implementation, or vendor selection between 2008-2010. The most commonly engaged firms were Deloitte at 18% and CSC at 9%. It also found that 34% of participants had engaged a firm for revenue cycle management projects, with Huron being engaged by 20% and Deloitte by 14%. The document provides breakdowns of firms used for both clinical and revenue cycle projects.
Multiplex Assays in Translational Medicine: Technologies, Applications, and F...ReportLinker.com
The development and growth of assay technologies has pushed translational medicine into a category unto itself. In a broad perspective on this field, this new report:Defines translational medicine by giving some historical background as well as providing personal definitions from experts in the field Discusses the evolution of assay technologies Reviews currently available assay technologies that apply directly to translational medicine Describes and evaluates current applications of these technologies Provides case studies of clinicians currently using this technology in their research Discusses future directions of assay technologies for translational medicine Gives input from the FDA on translation medicine and assay technologies Provides interviews from experts in the field of both translational medicine and specific assay technologies Profiles premier companies active in the field Assay technologies have been evolving since scientists first discovered they could measure glucose, insulin, and several hormones in the blood to help them diagnose disease. Early instruments such as the Ames Reflectance Meter, used for detecting glucose levels, have morphed into such sophisticated systems as flow cytometers. The Human Genome Project provided the basics for researchers to launch into the field of human genomics and they needed the tools to accomplish this. DNA microarrays allowed for massively parallel gene expression analyses. Scientists soon discovered that while the genomewide assays were extremely valuable, there were genes of interest that they had difficulty measuring when they got hundreds of data points from a microarray. Low- to mid-density assays have allowed scientists to pinpoint the genetic code for a variety of uses, from genetic heredity studies to drug metabolism and patient stratification.
The document discusses diabetes management and emerging wireless solutions. It describes how WellDoc uses wireless technologies and a virtual coach to help diabetes patients better manage their condition through medication reminders, blood glucose tracking, and behavioral modification tools. A case study shows how WellDoc helped a patient lower their A1c level and improve self-management over 3 months by analyzing their data, providing education, and facilitating collaboration between the patient and healthcare provider. The conclusion emphasizes how WellDoc aims to engage and empower patients while also supporting clinicians.
Sandor Szalma (Janssen) gives an overview of this potential Pistoia Alliance working group during the "Dragons' Den" session of the Pistoia Alliance Conference in Boston, MA, on April 24, 2012.
Healthcare institutions are aggressively moving towards meeting compliance with MU1 and MU2 with the implementation of full-featured Electronic Health Records. Concomitantly, there will be a massive increase in the amount of clinical data captured electronically. Business intelligence (BI) which traditionally has focused on financial data can be leveraged to use clinical data to support providers in delivering high quality, efficient care. In addition, BI coupled with population health analytics can help meet many Accountable Care Organization needs. This presentation will discuss the Denver Health journey in using BI in a variety of was to facilitate the attainment of high quality care.
This document summarizes the work of a team developing a company called CanScan to advance personalized cancer treatment. The team cultured circulating tumor cells (CTCs) from blood samples to characterize cancer cell aggressiveness and test drug responses. Key findings included that culturing CTCs could provide valuable data to guide treatment decisions. The team refined their business model to partner with diagnostic companies and provide CTC testing services to oncologists and pharmaceutical companies. Next steps involved further validating the technology and business through clinical trials and partnerships.
This document discusses chronic diseases as a major problem in New York state and Governor Cuomo's efforts to address it. It outlines New York's Medicaid Redesign Team plan, which focuses on patient-centered medical homes and health homes to improve population health and lower costs. It also discusses the role of integrated care management, telehealth, and technology companies in coordinating care delivery.
KurkMedical is a company that provides services to the medical industry in Europe and the Middle East. It offers services related to regulatory requirements, reimbursement policies, markets/payers, product launches, strategic decisions, implementation/control, health economic studies, and regulatory strategies. The company's strengths include being outcome-oriented, responsive and fast, and having extensive experience in the life science and healthcare industries. It employs experts in clinical research, regulations, marketing, and business development based in Belgium and Dubai to serve customers in research, healthcare, pharmaceutical, and diagnostic fields.
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Dual Role of TGF-b in Inflammatory Fibrotic Disease Melanie Ruzek Ph.D....crystalhuntergtcbio
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GTCbio organizes biomedical and biopharmaceutical conferences to facilitate information exchange between industry leaders, academics, and government organizations. Upcoming conferences in January 2010 will focus on cancer drugs in development, cytokines and inflammation, and challenges in global clinical trials. The document provides details on conference topics, speakers, and registration information. Sponsorship opportunities are also described to maximize return on investment through networking.
The Expanding eClinical Universe: Streamlining Progress by Changing Current Work Processes and Moving Away from Paper Alan S. Louie, Ph.D., Research Director, IDC Health Insights
1. The Expanding eClinical Universe:
Streamlining Progress by Changing Current
Work Processes and Moving away from Paper
Alan S. Louie, Ph.D., Research Director
IDC Health Insights
Challenges in Global Clinical Trials Conference
January 28, 2010