Institutional Review Boards are charged with monitoring clinical trials that go through the institution to ensure patients safety and to ensure the principles for good clinical research are maintained. The FDA has decide to monitor the quality of the decisions being made by some IRB’s in commercial research institutes, in what appears to be a break from the normal methods of Audit, where they review past decisions, in the case of Coast, a for profit Independent review board, the FDA submitted a bogus clinical trial protocol, for a fictitious product and fictitious company, when the board approved the study the FDA sprang its trap. Now Coast are facing some very difficult questions, shedding staff and shedding business.
Mystery shopper is a different path but this author asks where will they take it next, fake safety reports, fake adverse event reports, its the natural evolution of the Audit.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical
or biotechnology) and regulatory consultant, we work with our clients
to define a drug development target, define a drug development
strategy, define a regulatory strategy or define a commercial strategy.
Our clients are generally raising funds or looking to license out their
technology and we help them achieve it. If you want to know more don’t
hesitate to get in touch.
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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