Data Management Featured Articles
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Survey: Do Spreadsheets Still Hamper Clinical Trial Speed & Quality?
8/8/2016
Clinical trial operations is fraught with many hurdles, including quality, cost, and timeliness. To successfully bring new medicines to market, operations managers have to successfully overcome these challenges. Application software provider Comprehend recently produced a “Clinical Operations Benchmark Report,” in which it surveyed executives at leading life science companies. The goal was to determine how companies can speed up trials and more quickly get to quality results across a portfolio of products.
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Clinical News Roundup: Is ClinicalTrials.gov Failing Patients?
7/29/2016
Clinical news roundup for the week of July 25, 2016 with information on ClinicalTrials.gov, patient empowerment, wearable technologies in clinical trials, clinical trial information, and India lagging in hepatitis research.
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3 Patient-Centric Steps to Increase Retention
7/26/2016
Patient centricity is a growing trend in our industry. From the creation of Chief Patient Officer positions to culture-change initiatives, one of the strategies to improve the quality of clinical trials is to treat patients as “consumers” rather than “subjects” in a study.
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Are Your Clinical Trials Prepared For The Coming mHealth Tsunami?
7/18/2016
Excitement around mHealth technologies has been building for years. While initial apprehension kept many companies from jumping into the space, sensors are finally starting to make it onto patients. In this Q&A, Glen de Vries, president of Medidata Solutions, discusses progress the industry has made, concerns that remain, and what the future holds for mobile and wearable technologies.
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Study Rescue: How To Get Your Clinical Trial Back On Track
7/13/2016
Beth Harper has devoted more than 28 years of her life to the world of clinical research, including time at a sponsor, CRO, service provider, and start-up company while also serving as an adjunct associate professor at George Washington University. She is currently president of Clinical Performance Partners, where she works with companies to optimize study feasibility and site selection and helps to improve site relationship management practices. Although her passion is to work on proactive protocol and site performance optimization strategies, she will tell you that most of her time is spent rescuing studies. In this Q&A, Harper shares her insights on the factors that will lead to a study rescue and what companies can do to prevent that situation from arising.
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Duke & PCORI Use EHRs To Transform Clinical Trials
7/11/2016
PCORI (Patient-Centered Outcomes Research Institute) and the Duke Clinical Research Institute have launched the ADAPTABLE study, a patient-centric trial designed to assess the benefits and long-term effectiveness of aspirin dosing. With a budget of over $14 million, the trial will randomize and dose 20,000 patients while leveraging health systems, EHRs (electronic health records), and patients in an attempt to fundamentally transform clinical research.
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IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For June 2016
7/8/2016
Below are my top three articles downloaded on Clinical Leader for the month of June 2016. In case you missed them, please take this opportunity to see what everyone else was learning about the clinical tragedy in France, using source data verification as a quality control measure in trials, and where the industry stands on eSource implementation.
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GSK’s Bold Move Into Uncharted mHealth Waters
7/6/2016
While some sponsor companies continue to fret over the challenges of incorporating mobile and wearable technologies into clinical trials, GSK is one sponsor that has been boldly moving forward. GSK’s thinking and efforts in this area are certainly attributes that others should emulate.
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TMF Survey: Major Changes To Clinical Operations
7/5/2016
Every year Veeva’s Paperless TMF (trial master file) Survey provides insights into the state of electronic TMF (eTMF) adoption in clinical trials. This year marks the third year for the survey, which explores the life science industry’s progress in streamlining clinical trials and efforts to unify clinical operations.
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3 Steps For More Effective Sponsor-CRO Partnerships
5/31/2016
Clinical Operations (ClinOps) leaders increasingly outsource critical components of their trials. By one estimate, 75% of pharmaceutical and biotechnology companies are now outsourcing data management and over 70% are outsourcing site operations. As a consequence of the growth of this practice, effective collaboration between Sponsors and their CROs has never been more critical for achieving clinical trial milestones on-time and within budget.