Pharmaceutical Technologist - May 2008 - (Page 17)

Integrated safety ● ● ● data, and to identify and track usage. The potential for misuse of the data exists and must be closely monitored. There is a necessity for regulatory acceptance to allow pharmaceutical companies and regulators to share adverse event data. Making patient data anonymous addresses some concerns regarding patient privacy. However, there needs to be a process for seeking explicit, informed consent from patients (similar to clinical trials) to have their health records included in the patient health information. Existing standards (CDSIC and HL7) should be converged to facilitate interchange of information between systems. Currently, different source systems store data using different standards. Unless these various source systems support consistent terminology, the feasibility of truly integrating the data is remote. PT Dinesh Kasthuril is a Lead in the Clinical and Drug Safety, Solutions and Consulting Group of the Life Sciences Practice of Cognizant. Dinesh has more than 10 years of experience working with leading pharmaceutical companies across Europe, Asia and the US. He has extensive experience in driving and delivering R&D strategy and business capability initiatives across the pharmaceutical product development value chain. of the Cognizant team with more than 10 years’ specialized experience in information management. www.cognizant.com On the go • Several high-profile drug withdrawals and a number of ADRs have led to increased scrutiny and raised safety standards. • The next step in the integration of internal clinical systems with external data will involve the expansion of the existing infrastructure to include patient health information. • Data integration increases patient safety in multiple ways: from increasing the quality of signal detection to enabling faster capture of adverse event data. • The biggest challenge is in defining policies to prevent misuse of patient data and consistent standards to allow interoperability. Partha Chakraborty is Head of Life Sciences Solutions and innovation champion of Cognizant Life Sciences Practice. He has worked with multiple global pharmaceutical companies in the US, and led IT transformation in clinical and safety, as well as the implementation of critical engagements. He also architected ASPIRE — Cognizant’s Drug Safety Framework. Rick Kite is Cognizant’s Practice Manager for Life Sciences in the UK. He is a senior member Stay more alert with PTE weekly Pharmaceutical Technology Europe (PTE) magazine is now publishing a weekly e-Alert providing a variety of editorial from the Pharmaceutical, Specialty Chemical, Biopharmaceutical and Contract Service/Outsourcing industries. E-Alerts will include Industry news Trends/forecasts Regulatory Affairs Key industry movers Financial results/Mergers & Acquisitions Industry events Opinion polls and surveys Recruitment opportunities Corporate news Join the 24,394 users who already receive the e-Alert by subscribing FREE now at www.ptemag.com and click on sign up: weekly e-Alerts now! www.ptemagazine.com 17 http://www.cognizant.com http://www.ptemag.com http://www.ptemag.com http://www.ptemagazine.com

Table of Contents Feed for the Digital Edition of Pharmaceutical Technologist - May 2008

Pharmaceutical Technologist - May 2008 Contents Industry Highlights Morpheus Market Watch Pharma’s Need for Integrated Safety Is Pharma’s Future Mobile? Facing the CRO Behemoths Q&A

Pharmaceutical Technologist - May 2008

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