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Pharmacovigilance Operations – Clinical trials

Case processing (SAEs)

The data generated from clinical trials tends to be more complete than that received through typical channels of spontaneous reporting. Likewise the steps for follow-up are often far easier to take. Nonetheless, you will need to demonstrate consistently that your reporting process is adequately specified and resourced to the task.

Expedited reports

Electronic Reporting of Suspected Unexpected Serious Adverse Events (SUSARS) is now mandatory in many global territories. As part of the service PrimeVigilance offers the facility to delegate the onerous task of registration and set up of the electronic reporting routes for the pharmacovigilance system. Experienced and EMA trained personnel ensure that expedited reporting meets the regulatory requirements in each trial territory. Whether electronic or hard copy PrimeVigilance offers consolidated expedited reporting services.

Periodic reporting (DSURs)

Additionally to the need for SUSARs, Development Safety Update Reports (DSURs) should be submitted to regulatory authorities and Ethics Committees throughout the clinical trial or on request. The DSUR takes into account all new available safety information received during the reporting period.

Clinical trial safety

Maintaining safety within clinical trials is of paramount importance to any pharmaceutical company wishing to bring new products to the market place or diversify your existing products. Compliant pharmacovigilance procedures during your pre- and post- marketing clinical trials are key to the eventual success of those trials and the granting of any Marketing Authorisation. Demonstrating this compliance requires a very specific set of skills to be constantly updated in line with regulatory changes.