Drug Safety & Pharmacovigilance
We are dedicated to safeguarding patient well-being and ensuring compliance with global regulatory standards through our comprehensive Drug Safety and Pharmacovigilance (PV) services. With a team of experienced pharmacovigilance professionals, we provide end-to-end solutions that help Sponsors monitor, assess, and mitigate risks throughout the clinical trial. We continue to stay ahead of evolving global regulations, ensuring your safety data is managed with precision and efficiency.
Key Drug Safety and Pharmacovigilance Services at WEP Include the Following:
Regulatory Compliance & Expertise
- Compliance with ICH-GCP, FDA, EMA, MHRA, PMDA, and other global regulations.
- Experience in handling clinical trial safety reporting (SAE, SUSAR, DSUR, etc.).
- Knowledge of EudraVigilance, MedWatch, and other regulatory reporting systems.
- Support for Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
Comprehensive Safety Services
- Case Processing & Safety Reporting:
- Timely and accurate processing of Adverse Events (AEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reactions (SUSARs).
- Medical Review & Signal Detection:
- Qualified MDs and pharmacovigilance professionals to assess safety data.
- Signal detection and risk-benefit analysis.
- Aggregate Reports:
- Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Clinical Study Reports (CSRs).
- Literature Surveillance:
- Monitoring published studies for potential safety signals.
Technology & Database Capabilities
- Validated Safety Database (e.g., ARISg, Argus, Veeva Vault Safety).
- Automation & AI-driven case processing for efficiency.
- Integration with EDC (Electronic Data Capture) and clinical trial management systems.
Risk Management & Signal Detection
- Signal detection, evaluation, and risk-benefit assessment.
- Implementation of Risk Management Plans (RMPs).
- Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs).
- Post-marketing surveillance and real-world data analysis.
End-to-End Pharmacovigilance Solutions
- QPPV (Qualified Person for Pharmacovigilance) services.
- Pharmacovigilance database setup and management.
- Signal management and benefit-risk assessment.
- Compliance monitoring and safety data reconciliation.
- Pharmacovigilance system audits and inspection readiness.
At WEP, we are committed to enhancing patient safety, optimizing compliance, and delivering high-quality pharmacovigilance solutions that support your product’s success. Whether you need full-service PV outsourcing or specialized safety consulting, we are here to help.
Why Choose WEP’s Drug Safety and Pharmacovigilance Team?
- A Dedicated Safety Team: Highly qualified PV professionals, physicians, and medical writers, with deep understanding of international safety regulations and compliance requirements.
- Cutting-Edge Technology: AI-driven analytics and automation to enhance drug safety surveillance.
- Flexible and Scalable Solutions: Ability to flex and scale services based on trial size and complexity Flexible pharmacovigilance support tailored to meet your project needs.
- 24/7 Support & Medical Monitoring: Ensure real-time response to adverse events and efficient case processing.
- Global Coverage & Local Expertise: Capability to handle multi-regional trials with local QPPVs (Qualified Persons for Pharmacovigilance).