Pharmacovigilance and Safety Management
As the pressure increases to ensure product safety, Pharmacovigilance is becoming vital to the business of pharmaceutical, biotechnology, medical device, and generic drug companies. While being focused on expediting approval for your product, we recognize the significance of identifying and mitigating risks during a clinical trial.
We at Vibgyor have devised a comprehensive spectrum of services to ensure patient safety. Vibgyor is committed to providing our sponsors with full support needed to meet their obligation for adverse event reporting. Through our dedicated, trained medical and safety staff with varied therapeutic backgrounds, we offer surveillance services through all phases of the clinical trial to assist in the development of your product.
Our Pharmacovigilance services include:
- Complete Serious Adverse Event (SAE) management & handling
- Creation & maintenance of a validated (21 CFR part 11) E2B compliant electronic database
- CIOMS line listings
- Risk-Benefit assessments
- Designing risk management plans
- Handling of adverse events and adverse drug reactions during clinical development and post-authorization
- Annual Reports or End of Study Reports
- Signal detection and ongoing safety evaluation
- Adverse event management for clinical trials.
- Post-marketing surveillance reports and Periodic Safety Update Reports (PSURs).
- Medical Monitoring Plan for clinical trials.