our team

 

Aaron Gorall - President
Aaron Gorall, founder and president of Sierra Clinical Services, is a seasoned clinical research and clinical applications professional with over 16 years experience in the medical device industry. He has managed clinical studies, extensively monitored study sites, attended numerous FDA inspections, trained surgeons on the use of new medical devices, and managed/mentored CRAs and clinical application teams. Aaron’s clinical trial experience includes Phases I, II and III as well as post-market surveillance studies.

Aaron played a key role in the FDA inspections and site monitoring for three FDA approved PMAs and one approved 510(k) ophthalmic medical device.

Jen Gorall - Vice President, Clinical Operations
Jen Gorall, co-founder of Sierra Clinical Services, is a seasoned clinical research and clinical data management professional with over 18 years experience in the medical device industry. Throughout her career she has designed, developed and managed clinical databases, managed clinical trials, monitored study sites, and managed/mentored teams of CRAs and data specialists. She has extensive experience in collaborating with statisticians during data analysis. Jen has also validated newly developed systems to meet FDA's 21 CFR Part 11 requirements. Her clinical trial experience includes Phases I, II and III as well as post-market surveillance studies.

Jen played a key role in obtaining FDA approval of three PMAs for ophthalmic medical devices as well as obtaining FDA approval of an NDA for an intraocular drug delivery product.

Sierra Clinical Team
Sierra Clinical has a team of seasoned CRAs as well as Clinical Coordinators to assist with project management and study monitoring needs. Additionally, Sierra Clinical has a team of experienced Data Specialists and Data Coordinators to support data management projects.