Clinical Research Solutions
FDA to Modify Informed Consent Rules, Seeks Feedback
On Tuesday, November 13th, FDA proposed to add an exception to its informed consent requirements for minimal risk FDA-regulated clinical investigations. Under the Agency’s current regulations,...
Clinical Research Solutions
FDA Seeks Feedback on Surrogate Endpoint Table
On December 13, 2016, the 21st Century Cures Act was signed into law with the intention of speeding FDA’s approval time for drugs and medical devices. When signed, the Cures Act increased FDA’s...
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...