Clinical Research Solutions
Human Subject Protection Regulations: Differences Between HHS’ & FDA’s Clinical Trial Rules
On Friday, October 12th, FDA issued a guidance document entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The document aims to help...
Clinical Research Solutions
Pros and Cons of Working with a CRO
Sponsors may transfer any or all of their many tasks and obligations relating to clinical trials to Contract Research Organizations (CROs). This ability to delegate through a Transfer of Regulatory...