Global Clinical Research, Quality and Regulatory Consulting Services

"Tina came very highly recommended to us at a time when we were looking for someone to help us navigate the regulatory requirements on investigational devices, support us in the preparation of a GCP compliant documentation system as a Sponsor and Investigational Site and submit our own clinical study protocol with an independent IRB. No one in the company had prior experience in navigating any of this!

 

Tina was fantastic – she was very practical in establishing the regulatory requirements that our company was obligated to. She was also very flexible in helping us adapt a process for the preparation and review of our documentation while staying within our budget. She has tremendous attention to detail, a very high work ethic, and incredible dedication to assisting you achieve your goals. She also has a very talented staff augmenting her expertise to provide a well-rounded team for your clinical project."