Our Pharmacovigilance experts help the sponsors identify early signals on the safety of their molecules. The Pharmacovigilance team is available 24/7/365 to ensure highest level of safety of the clinical research participants.
The Pharmacovigilance team comprises of safety physicians and specialists who are M.D., M. Pharm. and Oracle® AERS experts who work closely with sponsor to support drug safety monitoring.
We provide the following services across all phases of clinical trials:
- Serious adverse event (SAE) management and reporting during clinical trials.
- Adverse Drug Reaction (ADR) management and reporting for post-marketed drugs.
- Case Processing in pharmacovigilance database system & generation of CIOMS/ MedWatch
- Preparation or Review of Periodic Safety Update Reports (PSURs), Addendum PSURs
- Summary Bridging Reports
- Annual Safety Reports
- Preparation and management of Pharmacovigilance Inspections
- Preparation of Summary of Pharmacovigilance Systems
- Literature Searches and Literature Reviews
- Risk Management Plans
- Writing and/or managing safety data exchange agreements
- Harmonization of CCDS/SmPC
- Clinical Expert Statements
- Case Narratives
- Signal detection
- Workshops and Training (in-house company tailored courses; modular courses)
Software Platform for Pharmacovigilance
Our database is an Oracle® based tool that is MedDRA and WHO Drug coding supported and is compliant with 21 CFR Part 11. CliniRx uses Oracle® Adverse Event Reporting System (AERS) which offers an efficient and accurate processing of adverse events. Oracle Adverse Event Reporting System (AERS) is a comprehensive solution for product safety monitoring and compliance. It can be integrated with Oracle® Clinical and Oracle® Thesaurus Management System. It can produce regulatory reports from standard templates for regulations like MedWatch 3500a, CIOMS I, NDA Periodic, PSUR, IND Safety Update, Yellow Card, BfArM, MedWatch for Device, VAERS, etc.
