Medanta’s Pharmacovigilance personnel can manage all of your clinical trial safety requirements, including the following:

Writing the safety section for the trial protocol;

Training the clinical trial staff and investigator site staff on pharmacovigilance requirements;

Design of Case Record Forms and SAE reporting forms;

Provision of a central contact point for reporting of SAEs;

Case receipt, data entry, triage, MedDRA coding, narrative writing, medical review, quality control and reporting of cases to agencies;

Automated production of line listings for signal detection, trend analysis and risk management;

Writing of FDA annual reports and EU annual safety reports;

Management of your companies registration with EudraVigilance;

Provision of the responsible person for EudraVigilance;

Safety review and sign off on final clinical study reports;

Set-up, management and participation in Data Safety Monitoring Boards;

Preparation of safety sections for the Investigator Brochure;

Electronic reporting to EudraVigilance clinical trial module using an established gateway;

Utilisation of our own or client-specific SOPs .