Data Management Featured Articles

  1. Julian Jenkins Joins Clinical Leader Editorial Advisory Board 1/6/2016

    Dr. Julian Jenkins, VP and Head of Innovation, Performance and Technology within the Projects, Clinical Platforms & Sciences (PCPS) group in GSK Pharma R&D, has agreed to join the Editorial Advisory Board for Clinical Leader. Dr. Jenkins is accountable for performance management, business strategy and operations, and change management for PCPS, while maintaining a state of the art clinical and project technology infrastructure for the Pharma clinical organization.

  2. Lilly Expects Patient Centricity, Adaptive Trials, And New Technologies To Deliver In 2016 12/17/2015

    As the VP of Portfolio Management at Eli Lilly and Company, Anne White spends a good deal of time staying close to clinical trials, patients, and the latest trends affecting them. In her 24 years in pharma, most of them at Lilly, she has served as VP of Oncology Development Operations and Senior Director of Global Strategic Planning and Patient Tailoring. In this Q&A article, White shares her thoughts on pharma becoming more patient-centric and the increasing move towards more adaptive trials.

  3. Quintiles Chairman Reflects On 33 Years In Drug Development 12/8/2015

    On December 31, 2015 Dennis Gillings will officially step down as the Executive Chairman of Quintiles. When Gillings began working with pharma companies in 1974, shortly after coming to the U.S. from England, he was a professor of biostatistics at the University of North Carolina at Chapel Hill. His career in pharma started when he received a call from Hoechst, which later became Aventis and, subsequently, Sanofi

  4. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For November 2015 12/2/2015

    Below are my top three articles downloaded on Clinical Leader for the month of November 2015. In case you missed them, please take this opportunity to see what everyone else was learning about electronic health records, patient centricity, and planning for clinical success. 

  5. Risk-Based Monitoring: Understand It Before You Implement It 12/1/2015

    Duncan Hall, CEO Triumph Research Intelligence (TRI) and Triumph Consultancy Services, is dedicated to helping CROs and pharma firms align their core business processes with the latest technologies. Obviously a lot of his time is currently spent helping clients navigate the difficulties of implementing a proper RBM (risk-based monitoring) plan. Installing the technology is not difficult, but making sure the solution you select properly aligns with your needs can be a challenge.  

  6. Why The Cloud Is Set To Ignite A Clinical Trial Revolution 11/25/2015

    Clinical research is transforming from a paper-driven model into one that is almost wholly electronic. This goes well beyond the electronic transcribing of data. Wearables and smart phone technology now make it possible to electronically collect data directly from clinical research trial participants, skipping many manual and middle steps.

  7. Are We Moving From Strategic Partnerships Back To FSP Relationships? 11/23/2015

    What changes can you expect to see in clinical trials going into 2016? George Betts, Senior Director of Medical and Regulatory Affairs for Ipsen Biopharmaceuticals, believes patient recruitment and technology will continue to be a focus for sponsors going forward. He also believes that the specialty CRO market place will continue to grow as many sponsors move away from strategic partnering and go back to FSP relationships with smaller, specialty CROs.

  8. Can Electronic Health Records Bring Down Drug Prices? 11/2/2015

    Protocol development is a difficult task, even with the experts we have in pharma companies and clinics. One way of measuring the quality of those protocols is looking at the number of protocol amendments pharma companies generate. These are generally due to a protocol being too complex, or the criteria being too strict. Generally, the end result is not enough patients enrolled in the study on time. One solution to that problem might be the reuse of electronic health records (EHRs).

  9. Does Pharma Really Want Transparency In Clinical Trials? 10/27/2015

    My recent article on transparency in clinical trials, featuring Dr. Brad Thompson, CEO of Oncolytics, solicited a good number of comments and emails from readers. While most readers agree that more transparency would be good for patients and the industry, there seems to be a lot of disagreement over how it can be achieved, and if it can actually be achieved at all. 

  10. Do You Know If Concomitant Medications Are Impacting Your Trial? 10/20/2015

    There are a lot of things that can sink your clinical trial. Low patient recruitment, poor data, or issues with safety or efficacy, for instance. But what shouldn’t be a problem are issues arising with concomitant medications (two or more drugs used or given at or almost at the same time.) Unfortunately, many sponsor companies currently do not see concomitant medication tracking as a topic that is particularly important.