Creating a comprehensive and accurate database of efficacy and safety information

Abstract

The investigational licence for a new medicine granted to a pharmaceutical company requires all clinical experience to be fully documented. The company has a legal responsibility to provide complete and accurate evidence of the new medicine’s efficacy and safety to the regulatory authority granting the licence. Impeccable records of the clinical and laboratory observations from clinical trials must be held by the company. The process of collecting and of checking the information requires regular visits to investigators. A major task begins once these records are received inside the pharmaceutical company.