A medical doctor who pairs clinical expertise with an ethics-first view of research, leading international teams to a reputation for reliability and operational excellence.
We run trials and medical device studies across the UK, Central & Eastern Europe and Asia — pairing medical insight with operational rigour to accelerate enrolment without loosening a single control.
Paspigioni was founded by a medical doctor with one conviction: trial decisions should be guided by evidence and clinical judgement together. That shapes how we scope feasibility, recruit patients and defend data — competence first, documentation that stands up to inspection, timelines that hold.
Physicians, operations leads and regulatory specialists — one named owner per workstream, no handoff to an anonymous pool.
A medical doctor who pairs clinical expertise with an ethics-first view of research, leading international teams to a reputation for reliability and operational excellence.
Physician with 20+ years leading global clinical operations across CEE and the Middle East — vendor governance and inspection readiness.
A decade of oncological practice plus ten years of research leadership — CRA, project manager and sub-investigator, so every phase from start-up to close-out is familiar ground.
Drives global brand growth and go-to-market strategy, with a background at EY and Ciklum across clinical research and health technology.
Manages international submissions and compliance across oncology, pulmonology and cardiology — the direct line to ethics committees and authorities.
Feasibility and site selection, CA/EC submissions, contracts, eCRF design and validation, monitoring, EDC and data management through database lock.
Phases I–IV · device studiesComplete BE support from protocol and study planning to final analysis and regulatory submission, with audit-ready documentation at every step.
Protocol → submissionSafety reporting, aggregate assessments, PSURs, Risk Management Plans and ongoing benefit–risk evaluation with prompt signal detection.
Medical monitoringInvestigational product delivery, import/export coordination, temperature-controlled storage and distribution, inventory and central lab services.
Supply chainInformed consent, patient materials, protocols and regulatory documents translated with linguistic and cultural accuracy, on tight deadlines.
In-house teamContent and language tailored to your objectives and regulatory targets — technically accurate, compliant and genuinely persuasive documentation.
Regulatory-readyA decade of phase I–IV work in pharmaceuticals and medical devices built an unusually broad base — and one clear specialism at its core.
Deep knowledge and long experience in cancer studies — often in the most challenging indications. For sponsors in oncology drug development that depth is the difference between a plan and an enrolled trial.
Discuss an oncology study →“The entire Clinical Operations team has proven to be highly responsive and compliant, providing effective and timely support throughout the project — smooth, professional and solution-oriented.”
“Regulatory support and monitoring were always performed with great attention to detail, within agreed timelines. What stands out is responsiveness, proactive communication and a strong sense of ownership.”
“Enrolment goals were met at the assigned sites and documentation quality remained strong. Paspigioni would very likely be our partner of choice for future opportunities in Georgia.”
Five-plus BLA submissions are expected in 2026. The bottleneck is not the science — it is sites. The case for Armenia, Georgia, Ukraine and Uzbekistan: 75M people, 1,400+ modelled DMD patients, largely treatment-naïve.
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The shifting regulatory landscape, the operational complexity of cellular trials, and why emerging research hubs such as Georgia are becoming vital to this therapeutic shift.
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22–25 June, San Diego. The world's largest biotechnology event brings together 20,000+ industry leaders from 70+ countries — find us there.
Read more →Send a synopsis and we will come back with a feasibility view, indicative timelines and a costed proposal.
A member of the clinical team will reply within one business day.