Clinical, Regulatory and Market Access/HEOR
Extensive experience in clinical, regulatory, and market access/HEOR writing to support approval, market entry, and reimbursement across global markets.
Expertise includes:
- Development and review of clinical protocols and study reports, ensuring compliance with EMA, FDA, and MHRA regulatory requirements
- Clinical summaries, product monographs, SmPCs, and PIs
- Health Technology Assessment (HTA) submission documentation
- Global value dossiers (GVDs), AMCP dossiers, and reimbursement dossiers
- Payer Value Narratives (PVNs)
- Systematic and targeted literature reviews (SLRs)
- Objection handlers
- Interpretation and presentation of economic, real-world evidence (RWE), and patient-reported outcomes (PRO) data, in both text and graphical formats
- Economic modeling reports (e.g., cost-effectiveness, budget impact), indirect treatment comparison (ITC) reports, and comparative effectiveness analysis (CEA) reports
- HEOR manuscripts, posters, and abstracts
- Disease burden (clinical, humanistic, economic) reports
- Treatment guidelines and care pathways reports
- Evidence-based, data driven insights to support informed stakeholder decision-making
Deliverables are structured to meet the requirements of regulatory agencies, HTA bodies, and payers, ensuring scientific rigor, compliance, and clear communication of product value.
Examples of completed projects
| Deliverables | Therapy areas |
| Clinical study protocols and reports | Oncology (solid and haematologic malignancies), haematology, cardiology, gastroenterology, rheumatology, and rare diseases |
| Clinical summaries | Oncology (solid and haematologic malignancies), neurology, haematology, infectious diseases, rare diseases, |
| Product monographs/SmPCs/PIs | Oncology (solid and haematologic malignancies), haematology, respiratory, immunology |
| CEA reports |
Oncology (solid and hematologic malignancies) |
| HTA submission documentation | Oncology (solid and haematologic malignancies), haematology, respiratory, rare diseases |
| GVDs/AMCP dossiers | Oncology (solid and haematologic malignancies), immunology, haematology, neurology, nephrology, respiratory, cardiology, rare and ultra-rare diseases |
| HEOR publications, posters and abstracts |
Oncology (solid and haematologic malignancies), respiratory, neurology, dermatology, haematology, cardiovascular, rheumatology, nephrology, rare diseases
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Portfolio - HEOR publications
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