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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A new U.S. Food and Drug Administration (FDA) draft guidance gently reminds sponsors to list all clinical sites and entities handling clinical study–related activities when submitting New Drug Application (NDA) and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 […]

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,” […]

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 […]