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Pharmacovigilance
Introducing Mudra Clinical Research Organization (CRO) – We offer comprehensive pharmacovigilance solutions for clinical safety, post-market surveillance, and risk management plans. Our experienced Medical Affairs team diligently analyzes the safety profile of products throughout all clinical development phases and post-marketing.
Our tailored pharmacovigilance management plan ensures unique safety processes for each client. We provide full database and hosting services, handling safety data collection, validation, and international reporting. Clients can conveniently access their safety data remotely, anytime, and in real time.
Our Pharmacovigilance Services include:
- Safety Management Planning
- Development of Clinical Protocol Safety Section
- Protocol and Case Record Form Review
- Investigator Brochure Review
- Serious Adverse Event (SAE) Collection, Evaluation, Classification, and Reporting
- Coding Review for Adverse Events
- Periodic Safety Update Reports (PSURs), Annual Reports, and End of Study Reports
- Medical Case Review
- Safety Database Development and Maintenance
- Adverse Event Narratives and Coding
- Regulatory Reporting
- Setting Up Global Pharmacovigilance Systems as per Regulatory Requirements
- Reconciliation Services for Safety/Clinical Databases
- Regulatory Dictionary Coding – MedDRA, Sponsor Specific
- Remote Access through a Secure Link
Rest assured, Mudra CRO is committed to ensuring the safety and well-being of patients and supporting our clients in meeting regulatory compliance.
