Patient Safety in Clinical Trials

Management of serious adverse event is one of the crucial tasks for any successful clinical trial. Our highly experienced clinical research physicians provide medical expertise to evaluate the safety issues arises during clinical trial study and provide a safeguard to manage risk throughout study period.

PharmXL provide a comprehensive and flexible suite of drug safety services during the clinical trial:

Coordination of data safety monitoring committees

24/7- Serious Adverse Event (SAE) reporting and medical coverage

SAE handling, incl. assessment and narrative writing

Medical review of adverse events, labs, vital sign, ECG's, and any other study related datasets

Coding of adverse events, concomitant medications and other study related data in database

Medical review of all clinical trial related documents i.e. clinical study reports, etc.

Development Safety Update Report (DSUR) writing

Investigator and Ethic Committee safety notifications