by SOCRA | Apr 15, 2020 | Clinical Research, Investigational Drugs and Devices (IDE/IND)
Tim Reeves, CHFP Founder and Managing Director Human Factors MD Abstract: Human factors simulated-use studies provide a valuable tool for evaluating the usability and safety of medical devices, including combination products such as inhalers, injection devices, and...
by SOCRA | Mar 29, 2020 | Clinical Research, clinical research regulations, FDA, FDA Drug Approval
U.S. Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA). As our society becomes more global, it has become increasingly clear that the U.S. Food and Drug Administration needs to take a more...
by SOCRA | Feb 13, 2020 | Study start-up
Jennifer Goldfarb, CCRPSenior Director, Clinical Research Support OfficeChildren’s Hospital of Philadelphia Grace Wentzel, CCRPDirector, Clinical Research ServicesThe Research Institute at...
by SOCRA | Jan 24, 2020 | Institutional Review Board (IRB)
Click here to read part 1 IRB Audits and Inspections IRB audits can be conducted by federal agencies overseeing research such as the FDA or the Office for Human Research Protections, research bases, study sponsors, and IRBs. Pharmaceutical sponsors do routine...
by SOCRA | Jan 24, 2020 | Institutional Review Board (IRB)
Pamela Shoup, CCRPPast Executive Director, Toledo Community Oncology Program Current Research Manager and IRB Coordinator for the Toledo Clinic, Inc. Abstract: A well-organized institutional review board (IRB) ensures excellent quality assurance in the regulatory area...
