Medical Affairs
At WEP, our Medical Affairs team provides scientific, regulatory, and strategic expertise to ensure the success of clinical trials from study design to post-market support. We collaborate closely with sponsors, regulatory agencies, and investigators to ensure trials are scientifically rigorous, compliant, and aligned with market needs.
Key Medical Affairs Services at WEP include the following:
Scientific & Strategic Guidance for Study Design
- Support clinical development planning across all trial phases (I-IV).
- Provide disease-specific expertise to optimize protocol development.
- Ensure clinical trial design is aligned with regulatory and commercial objectives.
- Assist with endpoint selection, inclusion/exclusion criteria, and risk mitigation strategies.
Regulatory & Compliance Support
- Engage with regulatory agencies (FDA, EMA, MHRA, Health Canada) for scientific advice and study approvals.
- Ensure adherence to ICH-GCP, FDA 21 CFR Part 11, EMA, and local regulatory guidelines.
- Support the development of Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and regulatory submission documents.
Safety & Pharmacovigilance Collaboration
- Work with safety teams to develop Risk Management Plans (RMPs).
- Support adverse event (AE) and serious adverse event (SAE) reporting.
- Provide safety signal detection and benefit-risk assessment strategies.
Medical Writing & Scientific Communications
- Develop Clinical Study Protocols (CSPs), Investigator Brochures (IBs), and Informed Consent Forms (ICFs).
- Prepare peer-reviewed publications, abstracts, and conference presentations.
- Provide medical writing support for Clinical Study Reports (CSRs) and regulatory filings.
Key Opinion Leader (KOL) & Investigator Engagement
- Identify and collaborates with global Key Opinion Leaders (KOLs) and therapeutic area experts.
- Build strong relationships with investigators and research sites to enhance trial credibility.
- Organize advisory boards, investigator meetings, and expert panels.
Medical Education & Training for Sites and Investigators
- Provide protocol-specific medical training for study teams and investigators.
- Conduct educational workshops and training sessions on disease pathology, investigational product mechanisms, and trial best practices.
- Ensure investigator teams are well-equipped to enhance patient recruitment, compliance, and retention.
Market Access & Post-Approval Support
- Support sponsors in developing health economics and outcomes research (HEOR) strategies.
- Provide medical insights for market access, reimbursement, and commercialization strategies.
- Assist with Phase IV and post-marketing surveillance studies to generate real-world evidence (RWE).
Why Choose WEP’s Medical Affairs Team?
- Multidisciplinary Expertise: Our team includes board-certified physicians, regulatory experts, biostatisticians, and scientific writers.
- Therapeutic Area Knowledge: Extensive experience across oncology, cardiology, CNS, rare diseases, immunology, and more.
- Regulatory Excellence: Deep understanding of FDA, EMA, MHRA, and global regulatory landscapes.
- Seamless CRO Integration: Works in collaboration with WEP’s Clinical Operations, Data Management, Medical Monitoring, and Biostatistics teams.
- KOL & Investigator Network: Established relationships with key global opinion leaders and top research sites.