Joe Mills, Senior Director - Global Recruitment Center, inVentiv Health Clinical

Can CROs Take the Sting Out of CRA Travel?

Remote monitoring tools and other technologies aside, travel will remain a basic requirement for clinical research associates (CRAs) for years to come, says Joe Mills, senior director for the Global Recruitment Center with inVentiv Health Clinical. “It’s a core necessity and you can’t get away from it,” he notes. The demands of travel are also […]

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FDA Mailbag: Agency Addresses Monitoring, Study Close Out Concerns

Clinical trial practitioners seeking direct U.S. Food and Drug Administration (FDA) input for specific questions can leverage an online service from the agency’s Office of Good Clinical Practice. While extensive, it is an often-overlooked and cumbersome data repository. In this occasional series, ACRP wades through the posted questions and answers and provides highlights from some of […]

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ClinicalTrials.gov Revamps Website

For the first time since 2012, the National Library of Medicine (NLM) is set to unveil major upgrades to its popular ClinicalTrials.gov website. The website provides patients, family members, healthcare professionals, researchers, and the general public easy access to information on current and pending trials. As of May 25, it listed 245,000 clinical studies covering […]

Laura LaRosa, RN, MS, President, Sheldon Clinical Trials Consulting, Inc.

Is CRA Fraud Undermining Clinical Trial Integrity?

Nearly 85% of clinical research associates (CRAs) were fraudulently documenting informed consent during a Phase III trial involving more than 100 sites, according to an observational study of several clinical trials conducted by Laura LaRosa, RN, MS, president of Sheldon Clinical Trials Consulting, Inc. “I think [some form of clinical operations documentation fraud] is happening […]

Schulman IRB

The completion of the human genome project and advances in genetic engineering have paved the way for clinical trials involving human gene transfer, colloquially known as gene therapy research, to enter the mainstream. Gene therapy research involves the deliberate transfer of engineered genetic material to humans, with the goal of compensating for genetic mutations, conferring […]