Ms. EKta Shah, Regulatory Affairs Manager
Ms. Ekta Shah, our Regulatory Affairs Manager, is a seasoned professional in the realm of clinical research, bringing a wealth of experience and a sharp focus on regulatory compliance to our dynamic team. Holding a Bachelor’s degree in Pharmacy, Ekta’s educational background has been a tremendous asset in her role at AMCT. She has been instrumental in developing essential standard operating procedures (SOPs) in alignment with stringent regulatory requirements, ensuring that every facet of our clinical trials adheres to the highest standards. Ekta is meticulous in her role, overseeing technical study staff, verifying protocol adherence, documenting and reporting adverse events, and maintaining the integrity of data in case report forms (CRF/eCRF). Her expertise extends to monitoring and auditing clinical studies, participation in the consent process, study visits, and regulatory binder reviews, along with precise management of investigational product accountability records and training records.
Ekta’s commitment to regulatory compliance, meticulous approach to clinical research, and dedication to the highest standards make her an invaluable asset to our clinical trials team, significantly contributing to the advancement of medical science and patient well-being.