2017

EastHORN moves to Montrium’s eTMF platform

Tuesday, October 3, 2017

Montrium, an industry provider of Electronic Trial Master File solutions, announced that EastHORN Clinical Services has selected eTMF Connect to optimize its clinical programs and TMF management. EastHORN, a European CRO, will implement Montrium’s eTMF platform to increase transparency to enable greater collaboration with sponsors, improve compliance and provide greater value for its customers.

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Smart video conferencing a CNS diagnostic tool for CROs

Monday, October 2, 2017

For the past 20 years, we have watched cell phones morph into smart devices that do just about any function you can name. In this same converging trend, video conferencing systems now include “Smart” technologies enabling a multitude of functions to be performed beyond the legacy video conference function. Today, a CNS diagnostic tool has been created specifically for CRO usage using video conferencing.

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Cohen Veterans Bioscience to build wellness platform for brain disorders

Monday, October 2, 2017

Cohen Veterans Bioscience and Early Signal Foundation announce a partnership to advance the use of wearable and home sensors for real-time monitoring of patients with trauma-related and other brain disorders. Early Signal Foundation, a nonprofit organization focused on disruptive health solutions for rare disorders and underserved populations, will provide an affordable analytical system to record and integrate behavioral, cognitive, physiological and contextual data.

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New evidence extends validation for quality review

Monday, October 2, 2017

The Good ReseArch for Comparative Effectiveness (GRACE) checklist is a simple 11-item tool that considers the study purpose and provides questions to guide high-level evaluation of methods, data quality and analytics for use in health technology assessments of effectiveness and safety studies. It provides a scoring tool to help evaluate studies in the context of the study goal, and can be used by sophisticated and less experienced users.

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FDA Fast Track designations reach 20th year

Monday, October 2, 2017

Mixed experience but no changes in the forecast

Twenty years after its inception, the FDA’s Fast Track designation program is going strong, with many signs that it has achieved its goal of bringing novel drugs to the market faster. Now, even with a new FDA Commissioner at the helm, the Fast Track program is unlikely to change substantially, although it may adjust to more explicitly address current areas of high-unmet medical need such as antibiotic resistance and cardiovascular disease.

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Changes needed for EDC to show true efficiency

Monday, October 2, 2017

Three quarters of clinical trial managers report challenges loading data into their EDC systems, which in turn increases the time it takes to build study databases and then delays trials.
Eighty-three percent of life sciences organizations release a clinical database after the first patient, first visit. It takes an average of 68 days to build and release a clinical study database, which contributes to an increase of nearly a month downstream in the completion of a trial.

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