Inna Agapova, MD, PhD

More than 23 years in global clinical research, from monitoring trials at research sites to leading clinical operations teams and shaping start-up and monitoring strategy for multinational studies.

Experience

23+ years

Trials

Phase I–III, multinational

Areas

Oncology · CNS · Rare disease · Nephrology

Education

MD, PhD in Medical Sciences

Clinical background

Cardiologist, general practitioner

Languages

Russian, English, Finnish

What she does

• Leading clinical operations for Phase II–III multinational trials, from study start-up to close-out
• Site start-up and activation, including EU-CTR submissions, ethics and regulatory dossiers, and patient information and consent documents
• Risk-based monitoring strategies, resource models and quality plans for global studies
• Proposal and budget work for new studies: RFP responses, start-up and monitoring budgets, forecasting and bid defence
• Oversight of monitoring teams, trial master file completeness and inspection readiness under ICH-GCP
• Line management and coaching of clinical research associates

As a physician trained in cardiology and general practice, she brings a clinician’s view to how studies are planned and run.

Career

• 2025 – now
  Site Activation ManagerSyneos HealthGlobal start-up for a Phase II lupus nephritis / IgA nephropathy study (EU, US, UK, Canada, South Korea, Australia, Taiwan) and a Phase III rare disease study.
• 2020 – 2025
  Proposal Manager, start-up and monitoring strategy expertSyneos HealthStart-up, regulatory and monitoring strategies and budgets for hundreds of global study proposals in oncology, CNS, rare disease, nephrology and medical devices.
• 2017 – 2020
  Clinical Team Manager, EuropeSyneos HealthLed EU delivery of a Phase III Alzheimer’s disease trial (35 sites, 7 CRAs), a Phase II ophthalmology trial (~30 sites) and a Phase II acute pain trial (30 sites, 6 CRAs).
• 2012 – 2020
  CRA Line ManagerINC Research / Syneos HealthCoaching, performance reviews and workload planning for clinical research associates.
• 2007 – 2015
  Clinical Research Associate to Senior CRAINC Research, UKPhase II–IV studies in breast, bladder and gastric cancer, major depression and schizophrenia; CRA trainer, audits and CAPA.
• 2003 – 2006
  Clinical Research AssociatePSI Contract Drug DevelopmentMonitoring of Phase III oncology studies from initiation to completion.
• 1999 – 2002
  Cardiologist and general practitionerClinical practice, RussiaCardiology (coronary disease, hypertension, arrhythmia, myocardial infarction, stroke rehabilitation) and primary care.

Education and certification

• 2009
  PhD in Medical SciencesMechnikov Medical Academy, Saint PetersburgThesis on the role of chronic viral infections in the development of atherosclerosis.
• 2000 – 2007
  Cardiology residency and postgraduate studies in cardiology and epidemiologyMechnikov Medical Academy
• 1998
  MDMechnikov Medical Academy
• 2020
  Clinical Operations Lead certificate

Systems: Veeva Vault eTMF, CTMS, Medidata RAVE, Oracle Activate, Power BI.