Ensuring patient safety with optimized drug safety processes

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.

Positioning for Today and Tomorrow

Efficiency and compliance require a single source of truth, which is only possible with tightly integrated systems and processes that ensure the quality of the data as early as possible.

Requirements for transforming safety data operations:

• data governance
• integration governance
• functional robotic process automation (RPA)
• meaningful artificial intelligence (AI)
• cloud-enabled tools and systems

Whether your goal is to get the most from your current system and processes or to build new cutting-edge capabilities, NNIT can help.

NNIT Drug Safety Solutions

NNIT is the trusted safety partner for numerous Life Sciences organizations. We have been working in the drug safety arena for over twenty years. The NNIT Safety Advisory team works with Life Sciences organizations to understand their current situation and goals. Our initial analysis addresses essential aspects such as data governance, integration governance, system landscape, vendor evaluation, and selection. Once the initial analysis is completed, we provide implementation and configuration services, migration strategy and execution, integration, SOP/OCM/WI development, and ongoing application services.