Wayne Kubick, Chief Technology Officer for CDISC shares the latest initiatives from CDISC, implementing data standards for specific therapeutic areas; a toolset called share which is a metadata repository which will house all the CDISC standards to be used by applications within sponsor companies; and the continued expansion of capabilities and integration of data standards.
Trends in IRT
Bryan Clayton, Manager, R&D for Y-Prime, discusses trends in interactive response technology, including developing standards around IRT and addressing the pain points around IRT.
How to Choose a Tech Provider
Amy Black, MPA, PMP, Associate Director, eClinical Business Solutions at Onyx Pharmaceuticals describes the factors that go into deciding on a technology provider.
Big Data and Quality Data
Frederick A. Curro, DMD, PhD, Clinical Professor and Director PEARL, Practice Based Translational Network; Director, Regulatory Affairs, Bluestone Center for Clinical Research, New York University discusses the uses for quality assured data, along with data integrity to make better decisions for patients
Top Tech You Need to Know About
Wayne Kubick, Chief Technology Officer for CDISC shares his top technology advances clinical trials professionals should know about, including the impact of health wearables and how the data and insight will leverage advances in healthcare and clinical trials.
What Experts Look at in Technology
Amy Black, MPA, PMP, Associate Director, eClinical Business Solutions at Onyx Pharmaceuticals says clinical trials IT experts can see changes in the landscape to adjust decision-making.
Collaborations Require IT Safety Considerations
Jason Reynolds, VP Sales, Life Sciences for IntraLinks, discusses the increase of collaborations in the life sciences industry and how they can require IT protections to Intellectual Property.
How eConsent Improves Patient Understanding
Lindsay McNair, MD, MPH, MS, Chief Medical Officer, WIRB-Copernicus IRB discusses how eConsent positively impacts the informed consent process.
Quality Improvement in Clinical Development
Denise Calaprice-Whitty, Executive Director of Survey Research and Relationship Management Programs for The Avoca Group discusses how CROs and sponsors understand quality and quality by design.
Successful Strategic Partnerships
Johan Proeve, Global Strategy and Development Advisor, Global Data Sciences and Analytics, Bayer Healthcare, discusses the specific steps to make strategic partnerships work, and how CROs can work more effectively with sponsors.
Jennifer Goldsmith, VP of Veeva Vault for Veeva Systems, describes the current trends for electronic Trial Master Files in the life sciences industry.
Informed Consent in India
Lindsay McNair, MD, Chief Medical Officer, WIRB-Copernicus IRB, offers her views on the negative impact that videotaping informed consent had in India.
Differences Between Benchmarking, Metrics and Analytics
CEO of the Metrics Champion Consortium David Zuckerman explains the differences between benchmarking, metrics and analytics, and how they are used to positively impact performance in clinical trials.
Importance of Non-Interventional Studies
Nancy Dreyer, PhD, MPH, FISPe, Global Chief of Scientific Affairs, Real-World and Late Phase Research, Quintiles Outcome, outlines why non-interventional studies and comparative effectiveness studies are essential companions to randomized clinical trials.
Restoring "Lost" Trial Data
Peter Doshi, PhD, Associate Editor BMJ, discusses the proposal on Restoring Invisible and Abandoned Trials (RIAT) to ensure complete transparency in the clinical trials data area.
Pediatric Trials in the EU and US
Kathryn Elaine Bohannon, Principal Strategist with INC Research, explains how European and US pediatric policies be harmonized for more effective clinical trials in children?
New Analytics Tools Measure Quality and Performance
Peter Malamis, CEO or CRO Analytics and Michael J. Howley, PA-C, PhD, Associate Clinical Profession at the LeBow College of Business, Drexel University and Chief Science Officer, CRO Analytics describe the evolution of providing a seasoned analytics and scientifically validated and reliable instruments for measuring quality.
How the Role of the IRB is Changing
Lindsay McNair, MD, MPH, MS, Chief Medical Officer, WIRB-Copernicus IRB, describes how eConsent changes the consent process. While the regulatory role hasn't changed, but the different capabilities they need to address more complex clinical trials.
Clinical Data Transparency
In this video, Jamie Powers, Senior Industry Consultant, SAS Center for Health Analytics and Insights, describes how SAS has been on the forefront of data transparency for clinical trials.
Innovation in DrugDev
Hugo Stephenson, Executive Chairman, DrugDev discusses how innovation is helping improve clinical trials, and how the company is funding innovative companies and solutions.
Evolution of Outsourcing
Andrew Townshend, VP of Alliance Development for INC Research provides an overview of changes in the CRO industry and how the model and services have grown to address pharma's needs.
RBM Moves from Exploring to Execution
Duncan Hall, CEO, Triumph Consultancy Services, says sponsors and CROs are starting pilots in 2014 and fine-tuning their RBM approaches to get to the costs and quality benefits.
A "Person"-centric Change to Healthcare
Dennis A. Robbins, PhD, MPH, Director of Translational Policy & Ethics PEARL NYU, Chief Business Development Adviser CINA discusses how to get healthcare more person-centric and addressing behavior for a more improved health outlook.
Top Trends in eTMF
Brian Mundy, eClinical Product Manager at ePharmaSolutions, says that collaboration between sponsors, CROs and sites are going to be a bigger piece of the eTMF picture.
Choices in the ClinTech Ecosystem
In this segment, Amy Black, Associate Director, eClinical Business Solutions, Onyx Pharmaceuticals, discusses eClinical and how the acquisition of Onyx by Amgen is influencing tech purchases.
Safety In Pediatric Trials
In this segment, Kathryn Elaine Bohannon, Principal Strategist, Pediatrics, INC Research discusses how IRBs and Data Safety Monitoring Boards examine clinical trials in children.
Changing Role Of The Study Monitor
Penelope K. Manasco, CEO, MANA Consulting, discusses how RBM is changing the role of the study monitor and discusses the competencies site managers will need moving forward.
eConsent’s Impact on Patients
Lindsay McNair, MD, MPH, MS, Chief Clinical Research Officer, WIRB-Copernicus IRB, describes how eConsent changes the consent process.
The Importance of Clinical Research Sites
Christine K. Pierre, RN, President, Society for Clinical Research Sites, discusses how SCRS is growing and the initiatives it is offering for more meaningful site engagement for CROs and sponsors.
Social Media Listening
In this video, Melissa Mottolo, Patient Strategist Associate, Genentech, discusses how the sponsor uses social media as a way to improve the patient's experience in clinical trials.
Quality Metrics In Clinical Trials
Linda B. Sullivan, MBA, Chief Operating Officer, Metrics Champion Consortium, says FDA guidance on Quality by Design, as well as warning letters, have contributed to the demand for quality in clinical trials.
A Report On Paul Wicks, Head of Innovation, PatientsLikeMe
In this report, Editor Lisa Henderson discusses a recent interview with Paul Wicks and the new services for pharma that PatientsLikeMe introduced at DIA. Learn more about the learning healthcare system, which features patients at the center of the new paradigm.
Orphan Drug Development
In this segment, CEO of Prolong Pharmaceuticals, Abraham Abuchowski, discusses the challenges and opportunities in orphan drug development. Specifically, the outcomes, recruitment, and global reach necessary in drug development for smaller populations.
Rare Disease Pipeline
In this segment, CEO of Prolong Pharmaceuticals, Abraham Abuchowski, discusses its products in clinical development in the hematology/oncology space.
RBM Economics 101
High risk activities and high risk data are discussed by David Knepper, Head of Continuous Improvement, Forest Labs (now Actavis). Central to the focus is Risk-Based Monitoring, as well as Quality by Design built into clinical trials.
Patient Centricity Today
Anne Zielinski, Global Lead for the Patient Cloud at Medidata Solutions, discusses the key trends in patient-centric clinical trials, including social media and the opportunities of mHealth.
Keys to RBM Success
Moe Alsumidiae, President and Chief Scientific Officer, Annex Clinical, breaks down the Keys to RBM success, including the growth in IT infrastructure in this sector, the need to re-define risk in the qualitative and quantitative perspectives, and the need to close the gap in the skill sets.
Pharmacist: The Trust Factor in Patient Engagement
In this video, Moe Alsumidiae, President and Chief Scientific Officer, Annex Clinical, discusses the opportunities to leverage the trust patients have in their pharmacists, and the pros and cons of implementing clinical trials at the pharmacy level.
Industry Trends 2014
Moe Alsumidiae, President and Chief Scientific Officer, Annex Clinical, reviews what he sees as new trends, including eConsents, Risk-Based Monitoring advanced analytical systems, and customized database integration in IT, in addition to the progress TransCelerate has made with their initiatives.
Patient Reported Outcomes Today
Joseph Jackson, Associate Professior, Thomas Jefferson University, Program Director, Applied Health Economics and Outcomes Research Master's Degree, discusses his experiences with ePRO, the increase of the use of ePRO in clinical trials, and the use of social media and internet communications for amplifying patient voices.
In this video, Joe Selby, MD, MPH, the Executive Director, Patient Centered Outcomes Research Institute (PCORI) discusses the institute's involvement in the clinical trials industry, including interest in PRO and building a better infrastructure for trials, and the goals for PCORI's National Clinical Research Network (NCRN) .