Fares Alahdab, MD, Assistant Professor of Medicine at Mayo Clinic

Mayo Clinic Researchers Caution Against ‘Exaggerated’ Early Trial Results

In Greek mythology, Proteus has been called the god of “elusive sea change,” which suggests the constantly changing nature of the sea or the liquid quality of water in general. In clinical trials, the Proteus effect is a name given to a phenomenon of early exaggeration followed by moderation over time. A new study by […]

FDA Logo

FDA Calls on Sponsors to Improve Clinical Trial BIMO Documentation

A new U.S. Food and Drug Administration (FDA) draft guidance gently reminds sponsors to list all clinical sites and entities handling clinical study–related activities when submitting New Drug Application (NDA) and Biologic License Application (BLA) data to the agency. The guidance, “Standardization Format for Electronic Submission of NDA and BLA Content for the Planning of […]

Jack Corman, Principal Consultant to JHC Consultations

Robust Ethics Program Key to Successful Trials

“While the majority of people are well-intentioned, honest people, there are [those] who will bend the rules, break the rules, potentially hurt subjects, [and] hurt science,” says Jack Corman, principal consultant to JHC Consultations and the 2018 chair of ACRP’s Professional Ethics Committee. “ACRP's primary function is to improve the professionalization of clinical research,” he […]

Singapore

As Asia Expects Rapid Growth, ACRP and Singapore Institute Team to Train CRC Workforce

The Singapore Ministry of Health recently set aside $35m to help train and develop CRCs in the region. The investment will fund CRC salaries and national training and certification programs via the new SCRI Academy. Following ACRP’s announcement of a new partnership with Singapore Clinical Research Institute to raise CRC professionalism in Singapore, ACRP Executive […]

Jim Kremidas, ACRP Executive Director

ACRP, Singapore Clinical Research Institute (SCRI) Partner to Raise CRC Professionalism in Singapore

The Association of Clinical Research Professionals (ACRP) and Singapore Clinical Research Institute (SCRI) today announce a new partnership to raise clinical research coordinator (CRC) professionalism in Singapore. Under the partnership, SCRI will leverage components of ACRP’s Clinical Research Coordinator Boot Camp program to train CRCs employed within the local public healthcare system. Those components will […]