The drug safety function is facing many challenges because they operate in such a dynamic environment. The number of individual case safety reports (ICSRs) is growing exponentially. Regulatory requirements are constantly evolving. The ability to quickly act upon accurate safety information is becoming increasingly important. The recent Covid-19 pandemic and the demand for vaccines to fight it are prime examples.
Most pharmacovigilance teams face the added challenges of fragmented processes, capabilities gaps, and numerous system integrations that require governance resulting in:
- Duplication of data
- Manual reconciliation of data across departments and systems
- Increased risk of noncompliance
- Limited views of data across products, therapeutics areas, or portfolios
These combined challenges beg the question:
Can your organization effectively find, use, and rely on your data today?
Life Sciences companies can benefit from drug safety data processes that supply meaningful, relevant, and reliable output to the organization. By viewing the drug safety operation as a valuable resource instead of a cost center, these teams can take a more strategic approach to developing and maintaining safety systems and processes.