David Silberman, MPH, Co-Founder, Chairman, Clinical Research Fastrack

TIP Toward Success: Three Quick Steps to Take Your Site from Good to Great

PAID MESSAGE Good research sites get the job done, but great sites are transcendent. What does it take to transform your facility from good to great? Imagine your site exuding competence, collecting impeccable data, winning more trials, and increasing your revenue (along with your salary) from higher enrollment, improved retention, and faster results. What lessons […]

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HHS Delays Common Rule for Another Six Months

Delays are becoming commonplace when it comes to the Common Rule. The U.S. Department of Health and Human Services (HHS) just announced it is delaying, again, rollout of the revised Common Rule on the protection of human subjects in clinical trials for six months—until January 21, 2019. HHS is also granting an exception from the […]

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FDA Issues First in Series of Guidances on Patient Experience Measurement

The U.S. Food and Drug Administration (FDA) wants sites and sponsors to feel emboldened when it comes to measuring patient experiences during drug development—and at the same time, FDA wants to see some common sense, too. The agency has just issued a guidance on “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input” that represents the […]

Innovative Clinical Trial Design Survey Report

Industry Warily Approaches Innovative Clinical Trial Design

While clinical trial industry leaders are intrigued by the prospects for leveraging innovative trial design as a vehicle to drive cost savings and improve patient-centricity, more than half of the respondents to a new survey said they do not have a dedicated team or department devoted to it. And they aren’t sure they’ll ever commit […]

Effective Training Programs Can Reverse High Turnover Rates

“There’s nothing more frustrating than being in a role that you know nothing about [and receive] no training for,” says Teri Crumb, MSN, RN, CCRC, a clinical research nurse with Spectrum Health. “You’re not invested in it,” she can attest as a former clinical research coordinator (CRC). Among many downsides, it factors into a very […]