Iman is a strong clinical and regulatory expert with 15+ years’ experience in managing pharmaceutical and device studies, including domestic US trials, and larger multinational global studies. She works closely with the Regulatory department in the development and submission of IDE, IND, 510(k), and PMA applications for orthopedic devices.
As Sr. Clinical Director, Iman leverages her expert knowledge of FDA regulations and ICH/GCP guidelines to design pre- and post-market clinical studies in a manner that helps drive clinical and regulatory compliance and ensures superior data quality. She assists clients with the identification and qualification of orthopedic sites that help ensure their trial’s success. She has assisted with the development of clinical protocols that incorporate strategic regulatory, statistical and reimbursement objectives so that our clients can use each clinical trial to collect data required by all stakeholders. She also advises clients on the use of innovative statistical analyses that can help reduce a study’s sample size and/or allow for an early success/failure determination. Iman also provides strategic guidance to clients on how to maintain inspection readiness at research sites, and how to prepare for a BIMO inspection.
Prior to joining MCRA, Iman worked under the functional service provider arm of a large CRO (Syneos, previously known as Inventiv), where she conducted risk based monitoring, and was responsible for overseeing all aspects of Phase I/II study implementation for a major pharmaceutical company. Prior to working at Inventiv, she led several DoD funded trials at a medical device start up and served as a safety reporting consultant at NIAID (NIH). She also spent 5+ years managing Phase I-III HIV prevention trials funded by the Gates Foundation in the US, UK, Europe and Africa.
Iman graduated from Stanford University with a Bachelor of Science in Human Biology before gaining her Master of Science in Biotechnology from Georgetown University.