Data Management Featured Articles
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Using Real-World Data For Clinical Research: Challenges And Opportunities
1/21/2016
Across the country, there is growing awareness of challenges facing the clinical research enterprise. Among these challenges are the expense and logistical complexities of performing clinical trials, much of which is created by the need for elaborate, stand-alone data collection systems that are distinct from the systems used for normal clinical care.
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MDR-TB Study Requires A New Approach To Trials
1/19/2016
Otsuka Pharmaceutical has been an industry leader in TB drug development for over 30 years. The company is currently focused on MDR (multidrug-resistant)-TB, which refers to a form of the disease that is resistant to at least the two main first-line drugs available on the market.
In a recent clinical trial, many of the sites lacked proper personnel, training, and equipment. Learn how the company overcame these challenges to make the trial a success.
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Mobile Devices In Clinical Trials: Tested, Effective, Proven!
1/11/2016
Patient recruitment and retention remains a challenge for most pharma companies. New mobile tools bring the promise of a better patient experience, which would serve to alleviate both problems. And yet the conservative nature of pharma, coupled with regulatory concerns, seem to be keeping these solutions from gaining adoption. It’s no surprise that some technology companies are attempting to prove the effectiveness of these mobile tools themselves.
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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.
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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.
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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
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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.
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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.
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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.
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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.