Pharmacovigilance
Explore our pharmacovigilance services, where cutting-edge technology and expert insights converge to ensure the safety of investigational therapeutics, empowering you to make informed decisions throughout the drug development journey.
Ensuring investigational therapeutic Safety Through Expert Pharmacovigilance
Comprehensive Drug Safety Solutions Through Pharmacovigilance
We understand that robust pharmacovigilance is the backbone of successful clinical trials, ensuring that the safety of new therapeutics is never compromised. Our comprehensive suite of services encompasses everything from meticulous serious adverse event reporting and dedicated medical monitoring to advanced safety system design and global safety report submissions. Trust us to safeguard the journey of your product from development to market, empowering informed decisions that enhance patient safety and drive innovation in product development.
Comprehensive Drug Safety Strategies
Our Approach
Pharmacovigilance is vital when conducting clinical trials. Our approach includes:
- Serious Adverse Event (SAE) reporting and follow-up
- Automated coding (MeDRA, WHO-ART, WHO-DRUG) of adverse events and associated information
- Preparation and submission of global safety reports
- Preparation of IND safety reports and alert letters (SUSARs)
- Medical monitoring
- Post-marketing safety surveilance
What we Provide
Rigorous safety investigation has helped many new products enter the marketplace. We provide:
- Safety data management, processing, and reporting
- Data Safety Monitoring Board establishment and management
- Regulatory affairs expertise
- Real-time reporting of safety alerts for public-private partnerships