Maintaining safety within clinical trials, Suspected Unexpected Serious Adverse Events
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…read more
PERIODIC REPORTING (ASRS)
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...read more
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…read more