Taratec Announces Intelligent Solutions-PV(TM)

BRIDGEWATER, N.J., Nov. 2 /PRNewswire/ — Taratec, a leading life science solutions company that provides integrated business, information technology, and regulatory compliance products and services, today announced Intelligent Solutions-PV(TM), a family of enhanced products and services designed to help pharmaceutical companies better address pharmacovigilance and drug safety.

Taratec, a leader in the pharmaceutical industry for 20 years, specializes in regulatory compliance solutions that have been delivered to over 200 industry clients, including eight of the top 10 pharmaceutical companies. This new suite of products and services focuses specifically on the unique issues associated with patient safety and pharmacovigilance, for which the company has been delivering supportive services over the past three years.

The Intelligent Solutions-PV suite includes Signal Intelligence-PV(TM), Workflow Intelligence-PV(TM), and Operations Intelligence-PV(TM), each designed to address specific issues in diverse, but related, pharmacovigilance areas. These offerings enable companies to better embrace proactive monitoring and industry best practices in order to demonstrate adequate processes, procedures, signaling capabilities, and documentation. They facilitate compliance with Good Pharmacovigilance Practices (GPvP), essential for a company to demonstrate that it has followed the appropriate procedures during development and post-marketing to protect patient safety.

Signal Intelligence-PV can dramatically reduce the time and burden of analyzing drug safety data. It is configurable to easily integrate with existing safety databases, and its easy-to-use, interactive, visual analytics speed time to insights and eliminate the need for static reports. Signal Intelligence-PV provides interactive analysis results based on FDA’s Good Pharmacovigilance Practices that enable confident, collaborative decision- making to gain a complete understanding of the company’s entire product safety mosaic.

Workflow Intelligence-PV enables companies to optimize Adverse Event (AE) case processing through the application of modeling and simulation to better align limited resources to high risk areas, identify opportunities to reduce costs, rapidly respond to fluctuations in AE case load, and improve capacity and compliance. Our proprietary template-based AE process model development and simulation environment provides a safety analyst with the ability to examine alternative scenarios through simulations as well as implement business activity monitoring with customizable executive dashboards.

Operations Intelligence-PV provides a truly unique approach to drug safety assessments. Taratec’s proprietary methodology and technology focus on eight major domains and rate them against industry best practices. Clients are given results in the form of quantifiable metrics that identify areas of strength and areas that need further investment. Findings are documented and cross- referenced to the appropriate regulation (FDA, EMEA, ICH).

“The Intelligent Solutions-PV suite brings new pharmacovigilance capabilities to our marketplace that are based on Taratec core products, technologies and methodologies developed over the past several years”, explained Mark Kolb, Taratec CEO and Chairman. “We have been servicing the pharmaceutical industry since our inception, and our long term corporate commitment is to continue to broaden and extend our offerings with new products and services. Providing new ways for our customers to enhance patient safety is a logical result of that commitment.”

Intelligent Solutions-PV is available now and being delivered to selected customers. Pricing is based on the specific solutions being delivered and the services and products appropriate to customer needs. For further information, contact Taratec at 908.255.1600 and ask for Intelligent Solutions.

About Taratec
Taratec is a leading life science company that provides integrated business, information technology, regulatory compliance, pharmacovigilance, and drug safety solutions to innovative pharmaceutical, biotechnology, and medical device organizations around the world. With an extensive suite of services and solutions, Taratec enables life science companies to bring products to market sooner and improve manufacturing efficiency while achieving compliance with FDA regulations. Taratec is headquartered in Bridgewater, NJ, with a major operations center in San Juan, Puerto Rico. For more information, please visit www.taratec.com .