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