Nikki Christison, CCRA, TIACT, President, Clinical Resolutions, Inc.

Why are Soft Skills So Hard? Part III

Soft skills continue to challenge us in our “hurry up and do more, with less” environment. Often, we don’t take the time to carefully explain why we are asking for something. In Part I and Part II of this series, we touched on the importance of utilizing more thoughtful communication skills at the sponsor/contract research organization […]

John Boland, Vice President, Atlantic Research Group

New Coalition Works to Advance Rare Disease Trials

A new coalition featuring a wide swath of professionals in the clinical trial space hopes to serve as a platform to spark and share best practices and innovative ideas to accelerate the rare disease trial timeline. It won’t be easy, admits John Boland, vice president with Atlantic Research Group, a contract research organization helping to […]

Glenda Guest, CCRA, RQAP-GCP, TIACR, vice president of Norwich Clinical Research Associates Ltd.

Should Physicians be Solely Responsible for Informed Consent? One State Thinks So

Editor’s Note: A recent Pennsylvania Supreme Court decision has ruled that physicians, not their delegates, should obtain consent for “…administering an experimental medication or device” (40 P.S. § 1303.504). It is unclear how this will impact obtaining consent in a research setting. ACRP reached out to Glenda Guest, vice president of Norwich Clinical Research Associates […]

European Medicines Agency

European Medicines Agency Releases First-in-Human Trial Guidelines

The European Medicines Agency (EMA) just unveiled a guidance for first-in-human clinical trials designed to help stakeholders identify and address risks for trial participants. “Participants in these trials, often healthy volunteers, face an element of risk as the ability of researchers to predict the effects of a new medicine on people is limited before it […]

FDA Logo

FDA Gives Industry Green Light on IRB Waivers for Minimal Risk Studies

A new guidance from the U.S. Food and Drug Administration (FDA) assures sponsors, investigators, and institutional review boards (IRBs) the agency “does not intend” to object to an IRB waiving informed consent requirements for certain minimal risk clinical investigations. To remove this obstacle, however, the IRB must be in the position to demonstrate: The clinical […]