Adverse Event Processing: PatniADEPT Services |
Life Sciences companies are facing increased pressure from regulatory agencies to adhere to stringent timelines in reporting adverse events that may occur due to drug usage. The potential cost of failure in this area is huge: billions of dollars in terms of lost revenue, increased legal liabilities, and a damaged company image.
Backed by over 25 years of experience, Patni provides an integrated technology and services solution to help clients reduce the cost of processing adverse event reports, improve the efficiency of Pharmacovigilance operations and ensure timely reporting of adverse events as per applicable laws and regulations. We provide cost effective, reliable, and compliant drug safety services for pro-active Pharmacovigilance by utilizing a fully validated, hosted drug safety database from one of the leading vendors.
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Leveraging the Software as a Service (SaaS) model, our solution eliminates the need for heavy capital expenditure and empowers clients with the flexibility to respond to changing market dynamics. |
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| How Patni Can Help |
| Patni is an integrated BPO-IT services provider with a recognized understanding of pharmacovigilance operations and compliance. Patni takes a unified approach to adverse event collection, processing, reporting and risk management. Utilizing a global delivery model, we provide services spanning the entire case processing lifecycle from intake and case triage to regulatory reporting and trend analysis. Our service portfolio includes data entry and coding, medical assessment, quality control review and correction, regulatory reporting, follow-up case management and signal detection. In addition, Patni’s case processing model offers integrated signaling and data mining. Patni and the client get joint access to the safety database which is configured to the client’s products and reporting requirements. Our team collects, assesses, and enters all AEs and SAEs, governed by our SOPs and client-specific work-instructions. Clients can access the system at any time to view the status of cases and approve for electronic submission. |
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