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Better Communication Between Sites and Sponsors/CROs Can Speed Trials, Cut Costs

Better communication between sites, sponsors, and contract research organizations (CROs) can improve clinical trial quality “from start to finish,” says Jeff Kingsley, DO, MBA, CPI, FACRP, chief executive officer at IACT Health and immediate past chair of the Association Board of Trustees for ACRP. For example: Many potential protocol design problems can be nipped in […]

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Inspiration From a Breast Cancer Survivor

PAID MESSAGE In October 2012, Teresa Dunlap, a vice president and general manager at PRA, discovered a lump in her breast. That discovery led to a breast cancer diagnosis. But Teresa tackled the news with a rock-solid support network, and in March 2013, her doctor declared her cancer-free. Recently, to mark her five-year anniversary as […]

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HHS Gives Industry Six-Month Breather on Common Rule Revisions

The U.S. Department of Health and Human Services (HHS) just issued a notice of proposed rulemaking (NPRM) that would postpone the agency’s revision to the Common Rule on the use of human subjects in clinical trials for another six months. HHS also suggested it was open to discussing the addition of three so-called “burden-reducing provisions” […]

Cynthia Hahn, President, Integrated Research Strategy, LLC

Even Isolated Clinical Trial Fraud Damages Public Reputation

While clinical trials have an impeccable safety record, it doesn’t take much to give the industry a black eye in the public record. According to a recent article in Futurism, more than two dozen people received an experimental treatment to combat herpes between 2013 and 2016 from a researcher. The problem? The so-called “trial” was […]

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TransCelerate: A Not-For-Profit Entity Created to Drive Collaboration

PAID MESSAGE In 2012, key leaders from leading biopharmaceutical companies across the globe came together to create TransCelerate BioPharma Inc., a unique nonprofit focused on addressing inefficiencies, and advancing innovation in research & development. TransCelerate’s mission is to collaborate across the biopharmaceutical research and development community to identify, design and facilitate the implementation of solutions […]