Study Conduct

Biosimulation takes center stage in determining pediatric dosing during clinical trial process

Saturday, August 15, 2015

Biosimulation is playing a growing role in drug development, espe­cially with candidate drugs intended to treat pediatric populations. Re­searchers want to minimize children’s exposure to experimental drugs. Therefore, they increasingly are turn­ing to physiologically-based phar­macokinetic (PBPK) modeling and biosimulation to provide insights into how a candidate drug might behave in younger subjects.

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Verified Clinical Trials inks two partner agreements

Thursday, August 13, 2015

AXIS Clinicals USA, a Dilworth, Minn.-based CRO, has partnered with the Verified Clinical Trials (VCT) national clinical trial database registry to stop attempts at dual enrollment in clinical trial research, thus preventing protocol deviations, improving data quality and promoting subject safety. Within the first seven days of use, the VCT system proved its worth by stopping a subject’s attempt at dual enrollment. VCT is the largest North American database registry in both early and late phase clinical trials.

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Lundbeck joins Global Alzheimer’s Platform

Monday, August 10, 2015

Lundbeck, a global pharmaceutical company specializing in brain disorders, has joined the Global Alzheimer’s Platform (GAP) to help accelerate the development of new treatments for Alzheimer’s disease. GAP is a research initiative that aims to reduce the time and costs of Alzheimer’s disease clinical trials, develop an infrastructure that promotes innovation, and assure international collaboration on Alzheimer’s disease treatments.

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Transparency Life Sciences assesses feasibility of decentralized patient data collection

Friday, August 7, 2015

Transparency Life Sciences, a clinical-stage drug development company based on open innovation, has enrolled its first patient in a new ulcerative colitis trial designed to assess the feasibility of replacing most conventional patient site visits with data collected using a combination of decentralized methods, including digital measurements, telemonitoring, remote video visits with clinical trial staff and blood collections by visiting nurses. In addition, the study is the first to allow key clinical endpoint assessments to be made by the subjects’ own gastroenterologists, rather than via designated sub-investigators affiliated with the trial.

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Is there really a shortage of study volunteers?

Saturday, August 1, 2015

Patient recruitment remains one of the biggest challenges facing the clinical research enterprise today. Forward-thinking industry leaders recognize the need for rethinking the common view that pa­tient recruitment is difficult primarily due to a shortage of study volunteers. Instead, these experts believe the industry needs to focus the discussion on practices that limit access to clinical trials and how to build support sys­tems needed to better engage patient commu­nities and the public in clinical research.

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Clincierge expands clinical concierge services for trial participants and families

Wednesday, July 29, 2015

Clincierge, a Philadelphia-based provider of specialized services and personalized support designed to overcome barriers to patient participation in clinical studies, expanded its patient concierge service into Cyprus. This is the 30th country where the company’s high-touch, one-on-one services for patients and families are available to aid companies conducting clinical trials increase trial enrollment and improve patient retention, thus helping to ensure that costly studies complete on time and on budget.

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AB Science warned about putting study volunteers in danger

Monday, July 27, 2015

The FDA’s Office of Scientific Investigations has issued a warning letter to Paris-based AB Science, a pharmaceutical company that targets cancer and other diseases with high unmet medical need, for compromising the safety of study participants by failing to properly monitor its clinical trials and ensure investigators follow protocol requirements.

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