Safety & Pharmacovigilance Systems


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Regulatory-Information-Management

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Key stakeholders of the Life Sciences industry such as patients, physicians, providers and payers are demanding safer drugs and faster responses from the industry to address their safety concerns. With global regulatory authorities giving drug safety more and more importance, the need to have a robust Pharmacovigilance system in place is crucial to an organization. There are quite a few PV applications developed on different technology platforms. Compliance to regulatory norms and adoption of key stakeholders from user community is critical for the success of these systems. Hence it is most important to have a blend of domain and technical skill to implement these systems.

Why PV Systems?

  • Increased scrutiny of drug safety due to high visibility drug withdrawals
  • Ensuring regulatory compliance as per the requirement of different agencies
  • Need to have surveillance programs through the product’s life cycle
  • Comprehensive case management and automated reporting
  • Integration of safety data collected through partners/affiliates

How Can TAKE Solutions Help?

TAKE has helped organizations strategize and build safety data marts, planning and execution of system migration as well as providing robust support for PV systems.

TAKE is a Gold Partner to Oracle in the Life Sciences space. We have developed our ‘OneClinical’ service offering based on Oracle HS suite. As a part of this offering, we have set up a customer experience center by implementing Argus Safety and integrating with other Life Sciences applications such as Oracle Clinical for SAE Reconciliation and Oracle LSH for Safety Data Marts.

TAKE has SafetyReady™, an accelerated solution for implementation, upgrade and migration for Oracle’s Argus Safety Suite. TAKE also offers Argus in a hosted environment through its SafetyReady™ Cloud solution.

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