Pharmacovigilance

Clinigene offers comprehensive Pharmacovigilance 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 management experience. The complete range of high-quality services offered by the Pharmacovigilance team encompasses:

• Set up and maintenance of global safety database
• Collection, evaluation, analysis and reporting of safety information from all sources including spontaneous reports of adverse events of the marketed drugs
• Literature search in compliance with regulatory requirements
• Medical review of case reports
• Online coding (MedDRA, WHO DDE)  of Adverse Events-
• 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

We also provide dedicated 24/7 phone and fax lines to receive information on adverse events from clinical trial sites and post-marketing sources.