Phase Forward Introduces Empirica™ Study, Major New Release of Clinical Trials Signal Detection Solution

Business Wire, June 23, 2009

Empirica Study, Formerly CTSD™, Extends Empirica Suite – Full End-to-End Safety Suite for Strategic Pharmacovigilance and Risk Management

SAN DIEGO -- Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced the availability of Empirica™ Study, formerly the Clinical Trials Signal Detection product (CTSD™). The Empirica Study solution helps clinical and safety teams improve their understanding of a product’s emerging safety profile during clinical development by facilitating the timely detection, review and analysis of safety issues in clinical trials data.

Empirica Study joins the Empirica™ Signal and Empirica™ Trace products to round out Phase Forward’s Empirica Suite, which supports safety review and risk management across the product development lifecycle, from clinical trials through post-marketing. These products are managed by the company’s Lincoln Safety Group, one of the most experienced and respected teams in the safety industry.

Empirica Study is an award-winning product that provides a dynamic visual data environment for reviewing safety data and detecting signals in trial data in CDISC Study Data Tabulation Model (SDTM) format. The new release streamlines study data updates for improved handling of in-stream data, and dramatically improves safety review and signal detection with new graphical displays and intuitive usability improvements for detailed drill-down and sophisticated graphical support. These capabilities complement the statistical algorithms and safety screening techniques which form the technical foundation for the product. This release includes the capability to apply its signal detection methods to a greater variety of more complex study designs, such as crossover studies.

“With the increased availability of standardized data in CDISC format, study sponsors have even greater opportunities to delve into clinical data, surfacing potential safety issues earlier in the process,” said Chan Russell, president of Phase Forward’s Lincoln Safety Group. “Using its statistical analysis algorithms, Empirica Study helps safety experts examine the most critical safety concerns and make informed decisions regarding the risk/benefit ratios of products in development.”

“Empirica Study includes both simple statistical tools that users with a clinical background will readily grasp and more sophisticated tools based on Bayesian statistics,” said William DuMouchel, chief statistical officer at Phase Forward. “Our work with early adopters in industry and at the FDA suggest that as standardized clinical data becomes more widely available, these tools will allow reviewers to explore relationships between adverse events and the rich set of covariates available only in clinical trial data.”

Phase Forward will be showcasing its products including Empirica Study at DIA’s 45th Annual Meeting in San Diego at booth #729.

The Empirica Suite of Products

The Empirica Suite is Phase Forward’s complete solution set for pharmacovigilance and risk management. In addition to Empirica Study, the suite includes the Empirica Trace product for adverse event data management and reporting and its companion Empirica Gateway which offers full support for E2B submission of case reports to regulators, affiliates and partners and receipt of data via E2B standard files. The suite also includes Empirica Signal, a state-of-the-art data mining and signal management tool. It provides detection and quantification of safety signals through the use of advanced data mining techniques that can be applied to any spontaneous reporting database.

Phase Forward’s safety products are used by regulatory authorities, biopharmas, medical device manufacturers and contract research organizations (CROs) of all sizes to implement proactive strategic pharmacovigilance programs. The product family name, Empirica, signifies the importance of empirical data in the decision-making process.

About Phase Forward

Phase Forward is a leading provider of integrated data management solutions for clinical trials and drug safety. Phase Forward’s products and services have been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial study participants at over 290 organizations and regulatory agencies worldwide including: AstraZeneca, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, the U.S. Food and Drug Administration, GlaxoSmithKline, Harvard Clinical Research Institute, Merck Serono, Novartis, Novo Nordisk, PAREXEL International, Procter & Gamble, Quintiles, sanofi-aventis, Schering-Plough Research Institute, Servier, Tibotec and the U.K. Medicines and Healthcare Products Regulatory Agency. Additional information about Phase Forward is available at www.phaseforward.com.