Clinical Operations Featured Articles
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Clinical News Roundup: Bioclinica To Be Acquired By Cinven
8/26/2016
Clinical news roundup for the week of August 22, 2016 with information on the Bioclinica acquisition by Cinven, SCRS Eagle Award finalists, supporting kids with brain tumors, reducing risk in adaptive trials, Zika testing in humans, and more.
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Overcome The Increasing Complexity Of Clinical Logistics
8/24/2016
Clinical trials have become more complex than ever. Although there is still some debate around exactly how complex they have become, trials today seem to have more endpoints, procedures, eligibility criteria, protocol amendments, and investigator sites than just 10 years ago. Add adaptive trials to the mix, and clinical supply executives have more to worry about than ever before. Perhaps it’s time to make your clinical supply chain as flexible as your trials.
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Clinical News Roundup: What To Expect From PDUFA VI
8/19/2016
Clinical news roundup for the week of August 15, 2016 with articles on the new PDUFA agreement, a super vaccine to guard against pneumococcal disease, the trends impacting clinical trials, the launch of VitalTrax, and new trial rules in India.
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With RE-VECTO, BI Investigates Clinical Use Of PRAXBIND
8/18/2016
Boehringer Ingelheim Pharmaceuticals has announced the launch of a global program designed to evaluate the use of its PRAXBIND medicine, which received FDA approval in October 2015. The program, titled RE-VECTO, will gather data to better understand the actual usage of PRAXBIND in clinical settings.
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Clinical News Roundup: Can Clinical Trials On Pets Help People?
8/12/2016
Clinical news roundup for the week of August 8, 2016 with articles on using pets in clinical trials, the Quintiles/DaVita alliance, the benefits and pitfalls of data sharing, and the Orphan Drug Act.
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How RBM Is Changing The Role Of Monitors
8/11/2016
Is risk-based monitoring (RBM) changing the role of monitors in clinical trials? In the latest issue of the Pharmaceutical Outsourcing Monitor, Michael Martorelli of Fairmount Partners takes a look at this issue, and features some interesting feedback from readers along with informative insights from Jim Kremidas of ACRP and Clara Heering of ICON. How is RBM changing the role of monitors and what do you need to know?
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J&J Takes The Lead In Clinical Data Transparency
8/10/2016
It’s a problem that clinical researchers have dealt with for years. A researcher has an idea for a study. They identify an existing data set, produced by other researchers, which would be ideal for that particular study. Although that data is not currently being used, the researcher is not able to access and use the clinical trial data because it is not being shared. This is a situation that Johnson & Johnson (J&J) is hoping to change.
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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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IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For July 2016
8/1/2016
Below are my top three articles downloaded on Clinical Leader for the month of July 2016. In case you missed them, please take this opportunity to see what everyone else was learning about GSK’s bold moves into mHealth, the efforts of Duke and PCORI to transform clinical trials, and the coming mHealth tsunami.
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Will Liquid Biopsies Transform Oncology Clinical Trials?
7/29/2016
Epic Sciences says it has developed a technology that CEO Murali Prahalad believes will transform oncology trials by identifying and characterizing circulating tumor cells. Those cells have been long recognized as a key part of cancer metastasis. Tumors shed these cells into the circulatory system where they then travel to different parts of the body and, under the right conditions, become the genesis of new tumors.