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FDA Warns Against Well-Intentioned Backdating

You may have the best motive and intent in the world when you backdate a clinical trial document. You may also still have a problem with the U.S. Food and Drug Administration (FDA). Example: A subject signs the wrong informed consent form (ICF) during a screening visit. The study coordinator later realizes that a signed […]

CTTI Seeks Investigator Input on Leveraging Mobile Technology in Trials

The Clinical Trials Transformation Initiative (CTTI) is asking investigators to share their perspectives on the use of mobile technology in research. The findings will inform the development of recommendations for the research enterprise on incorporating mobile technology in clinical trials research. CTTI is a public-private partnership co-founded by the U.S. Food and Drug Administration and […]

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 […]