Phase Forward Introduces Empirica Trace — Significant New Release Of Adverse Event Management Product
Phase Forward, a leading provider of data management solutions for clinical trials and drug safety, recently announced the Empirica Trace product, a significant new release of the company's adverse event reporting software, formerly known as Clintrace. With this new branding convention, Phase Forward is unifying its safety products under a new product family name - Empirica - for its suite of pharmacovigilance and risk management products. These products are managed by the company's Lincoln Safety Group, one of the most experienced and respected teams in the safety industry.
The Empirica Trace software provides a single, powerful solution that helps organizations collect, code, analyze and report adverse events to meet global regulatory reporting requirements. The product's streamlined Web-based architecture enables rapid deployment to multiple browser-based clients and helps minimize operations and support costs.
Important new features include global report distribution, quick data entry and triage, case lists, Structured MedDRA Query (SMQ) support, and expanded search and ad hoc query capabilities. The new rules-based report distribution functionality provides automated generation and delivery of reports based on case characteristics, product identity and recipient requirements. These and other new features are designed to enhance regulatory compliance and improve efficiency, reliability and performance for drug safety users.
"As a beta site, Sentrx has worked closely with Phase Forward during the development of this release and we are looking forward to implementing this exciting new technology," said Joseph Albano, CEO of Sentrx, a provider of technology enabled solutions and services for global drug safety. "The Phase Forward team worked diligently to understand the requirements of the market and incorporate them into the product. We believe this release will optimize our ability to deliver comprehensive adverse event reporting solutions to our clients."
"For the biopharmaceutical industry and regulatory agencies, the spotlight is on product safety as never before," said Chan Russell, president of Phase Forward's Lincoln Safety Group. "With its modern architecture, ease of configuration and automated report distribution capabilities, we believe the Empirica Trace product will help sponsors, government agencies and CROs streamline adverse event management and regulatory compliance."
The Empirica Suite of Products
The Empirica Suite Phase Forward's complete solution for pharmacovigilance and risk management - uses Empirica Trace as its foundation. The system's companion electronic submission option, the Electronic Case Submissions Module (ECSM), offers full support for E2B submission of case reports to regulators and receipt of data via E2B standard files. The Web Visual Data Mining Environment (WebVDME) performs data mining using publicly available data for marketed products. The Signal Management module facilitates the ongoing monitoring and tracking of safety signals, such as those identified in WebVDME. The Clinical Trials Signal Detection (CTSD) system supports signal detection from clinical trial data.
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 new 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. The company offers proven solutions for electronic data capture (InForm), phase I clinic automation (LabPas), clinical data management (Clintrial), clinical trials signal detection (CTSD), strategic pharmacovigilance (WebVDME and Signal Management), adverse event reporting (Empirica Trace) and applied data standards (WebSDM). In addition, the company provides services in the areas of application implementation, hosting and validation, data integration, business process optimization, safety data management and industry standards. 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 260 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.
SOURCE: Phase Forward