Post-Marketing Surveillance
Regulatory submission marks the end of the clinical trial phase and the start of post-marketing surveillance – Phase IV studies. At WEP, we specialize in managing Phase 4 clinical studies that generate real-world evidence, assess long-term safety, and support post-marketing commitments. Our expertise ensures that your therapy achieves sustained success beyond regulatory approval, helping you maximize its value in the marketplace.
As Part of our Phase 4 Offering, WEP Provides the Following:
Post-Marketing Surveillance & Safety Monitoring
We design and execute pharmacovigilance programs, post-authorization safety studies (PASS), and risk management strategies to ensure continued patient safety and regulatory compliance.
Real-World Evidence (RWE) Generation
Our team collects and analyzes real-world data from diverse patient populations, supporting label expansions, health economics studies, and payer negotiations.
Observational & Longitudinal Studies
We conduct registry studies, retrospective analyses, and prospective cohort studies to evaluate long-term treatment outcomes in real-world clinical settings.
Health Economics & Outcomes Research (HEOR)
We generate compelling evidence on a product’s cost-effectiveness, patient-reported outcomes (PROs), and quality of life improvements, aiding in reimbursement and market access.
Medical Affairs & KOL Engagement
We collaborate with key opinion leaders (KOLs), investigators, and medical experts to enhance study credibility, support peer-reviewed publications, and drive scientific discourse.
Regulatory & Compliance Excellence
Our team ensures seamless compliance with global health authorities (FDA, EMA, MHRA, PMDA) and industry best practices (ICH E6(R2), GVP, GDPR) for post-market studies.