Maryna Kolochavina | Project Director, Real World & Late Phase
INC Research/inVentiv Health

Maryna Kolochavina, Project Director, Real World & Late Phase, INC Research/inVentiv Health

Maryna Kolochavina, PharmD, PMP, Project Director, RWLP Operations, Europe and Asia Pacific, has over 12 years’ experience in worldwide clinical research and observational studies in various roles within the CRO and Pharma Industry. Broad experience in post-marketing research, project management, studies remediation, market launch, quality assurance, feasibility and clinical operations. Oversight for clinical projects and observational studies varying in size and locations (from global clinical studies ranging from 20 to 14,000 patients and observational studies from 150 to 100,000 patients to single country projects in rare diseases), as well as study phases (I, IIA/IIB, IIIA/IIIB, IV) and study designs, such as disease and product observational registries with prospective and retrospective data collection, pregnancy registry, observational FUP, retro chart review studies; early access to orphan drugs; compassionate use programs (CUP) / expanded access programs (EAP) (including named patient program (NPP), ATU, Special Access, IND); safety surveillance studies (including active and passive surveillance, descriptive drug utilization , post-authorization safety studies (PASS), post-authorization efficacy studies (PAES); non-interventional studies (NIS) with ePRO, HEOR and EPI modules; device studies.

back to speakers