Research Management

Clinical operations · Medical research

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 II–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

2020
CTM certificate
2009
PhD diploma
2002
Cardiologist certificate
1999
Therapist certificate
1998
MD diploma

Systems experience

Salesforce, Clinical Forecasting Systems, Resource Tools, Veeva Vault eTMF, CTMS, Medidata RAVE, Oracle Activate, Power BI.

Medical research

Ekaterina Agapova

Final-year Biomedical Science student at the University of Birmingham, UK, now writing her degree project in neuroscience.

University: University of Birmingham, UK, since 2022
Programme: Biomedical Science, final year
Degree project: Neuroscience
Languages: Russian, English, Chinese
Laboratory placement: University of Birmingham, 2026: cancer cell research
Internships: Two internships in the laboratory of Solopharm, a state-of-the-art pharmaceutical plant in Saint Petersburg
School: Gold medal, Gymnasium No. 652 with in-depth study of Chinese, Saint Petersburg

Ekaterina finished school with a gold medal at Gymnasium No. 652 with in-depth study of Chinese in Saint Petersburg. Her interest in biomedicine took her to the University of Birmingham in the UK, where she is in her final year and will defend her degree project in neuroscience. She has completed two internships in the laboratory of Solopharm, a state-of-the-art pharmaceutical plant in Saint Petersburg, and in 2026 a laboratory placement at the University of Birmingham, working on cancer cell research.