Safety Reporting & Pharmacovigilance Service
The stringent regulations on safety monitoring and their periodical revision have led to increased safety data collection, analysis and regulatory surveillance, and increased costs. Thus, Pharmacovigilance has become a critical phase in clinical development programs.
Our Pharmacovigilance Services help you ensure regulatory compliance, enhance efficiency and reduce costs significantly. We are offering the service of CRO in India that operate within a partnership model, where you benefit from our domain knowledge, quality systems approach, multi-disciplinary safety expertise and adherence to reporting timelines of the EMEA, FDA, MHRA and other competent authorities.
We, at ICBio, offer complete Pharmacovigilance Services, which include data collection, processing, medical review, safety writing, report writing, reporting, signal detection and analysis.
ICBio is one of the Pharmacovigilance companies in India offering comprehensive solutions across all phases of clinical development and post-marketing to pharmaceutical, biotechnology and medical device companies. The dedicated Pharmacovigilance team comprises of Clinical Pharmacologists with in-depth knowledge in diverse therapeutic areas and several years of Pharmacovigilance and safety project management services experience. The complete range of high-quality services offered by the Pharmacovigilance team encompasses:
Drug safety and Pharmacovigilance Services:
- Set up and maintenance of global safety database.
- Literature search in compliance with regulatory requirements.
- Collection, evaluation, analysis and reporting of safety information from all sources including spontaneous reports of adverse events of the marketed drugs.
- Online coding (MedDRA, WHO DDE) of Adverse Events.
- Medical review of case reports.
- Preparation of safety narratives.
- Preparation and submission of Periodic Safety Update Reports (PSURs) to regulatory authorities.
- Preparation and submission of expedited reports to regulatory authorities.
ICBio is one of the prominent Pharmacovigilance companies in India that deliver services within time and budget, further assist in lowering the overall cost base for drug safety activities that is ensured through focus on.
Short lead-in times, clear and concise processes tailor made to meet client expectations ultimately leading to effective client management and their satisfaction.
We are also providing dedicated service in clinical trials in India with 24/7 phone and fax lines to receive information on adverse events from clinical trial sites and post-marketing sources.