Patni launches drug safety reporting

BANGALORE, INDIA: Patni Computer Systems, a leading global IT services provider has announced the introduction of a new service that will perform adverse event case processing for pharmaceutical companies.  PatniADEPT, announced at the 44th annual Drug Information Association (DIA) conference in Boston, addresses the challenges life science companies face due to increased pressure from regulators to tighten reporting structures and from the marketplace to avoid costly missteps in the drug production cycle.

The solution, delivered by Patni Life Sciences, is one of the first to provide a cost-effective, unique service for drug makers and pharmaceutical customers of all sizes with an integrated ITO and BPO capability to improve and streamline case processing functions.  PatniADEPT leverages industry-leading software that provides hosted support for the global collection, coding, assessment and reporting of adverse event data. 

“Safety and on-time reporting are top-of-mind issues for the many drug companies we work with, and we developed PatniADEPT to both help companies properly address those challenges and streamline their product delivery,” said Mark Kolb, SVP, Patni Life Sciences.  “We have the experience in life sciences markets, a proven global delivery model and the partnerships with industry-leading technology platforms to deliver the services clients need to measure up to the highest standards in the adverse event case processing field.”   

Additionally, PatniADEPT incorporates Signal Intelligence-PV™, Patni’s advanced visualization tool for signal detection and data mining. This tool delivers intuitive analyses of the company’s safety data, plus a comparison to related safety information in the FDA’s Adverse Event Reporting System (AERS), a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products.  The integrated approach ensures compliance with FDA’s Good Pharmacovigilance Practices.

PatniADEPT provides outsourced AE case processing to clients using industry-leading technology platforms including ARISg™ from Aris Global (www.arisglobal.com), a leading provider of software solutions for life sciences.   Patni also provides services based on a client’s in-house technology platform.

“We are happy to be working with Patni, a recognized global leader in Life Sciences consulting, IT and BPO services,” said Richard Jenkins, Global VP of sales for Aris Global.  “The power of our Total Safety™ platform for facilitating regulatory compliance and managing risk coupled with Patni’s BPO expertise is the type of end-to-end solution that pharmaceutical and biotech corporations are looking for.”

Patni provides cost-effective business process outsourcing services including the following:

* Call center for the collection of AE reports

* Expert medical triaging of AE cases by experienced safety physicians

* Expedited and periodic reporting of AEs to regulatory authorities

* Overall analysis and trending of cases (signal detection), to provide a clear picture of any emerging safety issues and potential signals  

Patni Adverse Event Processing Technology encompasses a wide variety of functions relating to a patient experiencing an undesired effect from a pharmaceutical product or device. Facets include data entry, coding, medical assessment, quality control review and correction, regulatory reporting, follow-up case management and signal detection.

"In this state of heightened regulatory and safety compliance, life science companies must be proactive in their pharmacovigilance activities, but few have the resources to do so,” said Ruchi Mallya, pharmaceuticals and vertical markets technology analyst with Datamonitor, Inc. “PatniADEPT would allow companies to focus their energies on their core expertise - drug discovery and development, while leaving the adverse event processing to those with more experience."