CONTEXT
A global healthcare client managing multi-country clinical trials needed an efficient system to monitor and report adverse drug reactions. The volume and variability of safety data from hospitals, research centers, and regulatory portals made it difficult to detect meaningful patterns and respond quickly to emerging safety concerns.
RESOLUTION
Our team of SAS experts developed a dynamic reporting framework tailored for global pharmacovigilance needs. Using PROC SQL, PROC REPORT, and advanced SAS Macros, we automated the detection of serious adverse events and streamlined the generation of standardized safety reports. The system supported real-time monitoring and ensured alignment with international regulatory requirements.
RESULT
The solution led to faster identification and resolution of safety issues, enhancing both patient safety and regulatory compliance. It improved transparency in safety communications and enabled more efficient interactions with global health authorities, reinforcing confidence in the drug’s safety profile.