Sergey Nikitin

Background

About Sergey Nikitin

Pharmacologist with 20+ years of experience in clinical trials and with broad knowledge in a wide range of therapeutic areas, research disciplines, drug research and development processes. Extensive additional experience in project management and business education through MBA program at University of Alberta School of Business. Experience in clinical trials management and processes from site evaluation, budget development, regulatory submissions, initiation, recruitment, protocol procedures, close-out activities and study audits. Knowledgeable about regulatory requirements such as Health Canada’s guidelines (TPD), Good Clinical Practice (GCP), Health Information Act, and Food and Drug Administration (FDA) regulations. Research ethics board experience including presentation and submission of new clinical trials applications, study updates, safety reports, amendments and informed consents. Experience in managing site staff, developing site processes, negotiating contracts, managing financials and working on multiple projects simultaneously and efficiently with proven results.