Dr. Olga Blokhina

Support for the immunology and hematology rare diseases programs including establishing biomarker diagnostic/disease management profile. Clinical documentation review (clinical trial protocol, IVD study protocol, safety management plan, medical monitoring plan, data monitoring committee set-up, study guidelines etc.); risks assessment and management. Regulatory intelligence/consultancy. Regulatory Inspections preparation and management.

Assigned partner for IMP and IMD clinical research programs (including review of protocol deviations, quality issues, emerging safety issues etc.). GCP and PV audits, regulatory inspections preparation and management. Due diligence projects (in-licensing).

Clinical documentation review: clinical trial protocol, informed consent form, case report form, safety management plan, medical monitoring plan, trial guidelines etc. Medical monitoring: data review, guidance to investigational sites and clinical operations personnel on patients eligibility and protocol related medical questions, medical input to site feasibility and initiation, SAE medical review. Development of QMS and audit program for clinical trials and PV Trainings for investigational sites and CROs.

Quality oversight of clinical research operations in the region. Subject matter expert for safety and inspection readiness in Janssen clinical operations European quality council. Trainings for investigational sites and clinical operations personnel. Emergency unblinding (process set-up and actual unblinding 24/7). Regulatory inspections preparation and management.