Lina Genovesi, PhD, JD

Lina Genovesi, PhD, JD


Sample Banking for Future Clinical Research

November 11, 2013

As the pharmaceutical industry continues to face increasing cost of drug development, sample banking for future clinical research provides the pharmaceutical industry with new opportunities to obtain biological sample collections that will allow it to investigate safety and efficacy in future clinical research and answer regulatory authority questions related to safety and efficacy at the time of registration.

The HIPAA/HITECH Omnibus Final Rule: Implications for Clinical Research Blog

July 26, 2013

On January 23, 2013, the Department of Health and Humans Services (HHS) published the Omnibus Final Rule (Final Rule) which modifies the "HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the HITECH Act and the Genetic Information Nondiscrimination Act of 2008."