Posted by: @ak977 As Dr. S listed for us, the roles of a clinical project team are as follows: Clinical Project Manager, Clinical Research Associates (CRA’s), Monitors, Regulatory, Statisticians, Investigators, Site Coordinators, SROs, CROs, Centers, Labs, IRB’s, and Recruitment Organizations….   Read more»

Posted by: @ak977 Design Verification entails that the product you put out is what was actually requested and what the FDA has said is acceptable.Let’s say that the customer wants a product that addresses issues A, B, C, and D….   Read more»