Pharmacovigilance is the study of the safety of trial & marketed drugs under the practical conditions of clinical usage. It is done to assure the quality of pharmaceutical product or drug is preserved and to escort public welfare & wellbeing to prevent patients from any harm or damage. Hazards or damages can be minimized by competent pharmacovigilance setup will recognize the perils and disclose the peril causes in very short period of time.
IICRM offer services in pharmacovigilance to pharmaceutical, biotechnology and medical device organizations. We Offer this services for all the stages of clinical trial development, risk management and assuring safety during the complete clinical development and post-approval.
Pharmacovigilance includes the following services :
- Annual safety reports
- Contribution to risk signal detection
- Risk management strategy
- Receiving, processing, archiving adverse events/reaction information
- Medical assessment of individual cases
- Set up and maintenance of a global safety database
- MedDRA coding and coding convention strategies
- Medical support for SAE reconciliation
- Ensure compliance with local and international requirements
- Safety reporting to Health Authorities and other parties
- Periodic Safety Update Reports (PSUR)
- Preparation of SAE case narratives
- Preparation of written pharmacovigilance procedures (SOPs)
- Interim safety reports