Delivering Best-of-Class Solutions
Phase Forward’s portfolio of products and services consists of industry-leading data collection and data management solutions for clinical development and drug safety.
Our clinical data solutions include:
InForm™ ITM (Integrated Trial Management) – Electronic Data Capture
Our InForm ITM software is an award-winning Internet-based electronic data capture (EDC) solution that is used for collecting and managing patient information in clinical trials. Through the InForm platform, sponsors can gain near real-time access to operational and clinical trial data, anytime, anywhere. Users and sponsors have come to appreciate the data accessibility and quality enabled through InForm electronic case report forms, automated data checking and comprehensive reporting and analysis.
Market Acceptance: Since its introduction in 1998, the InForm solution has been used in over 1,300 clinical trials across multiple continents, involving tens of thousands of patients. The InForm ITM product is in use at 12 of the Top 20 global pharmaceutical companies, and it earned the 2005 Bio-IT World Best-of-Show Award.
Clintrial™ – Clinical Data Management
Our Clintrial software is a comprehensive clinical data management system that unifies all clinical data management information – regardless of its source (EDC or paper) – into one system for facilitated collection, management and review of clinical data. The Clintrial product provides comprehensive tools for automated data entry control and tracking, error checking, industry-standard clinical coding, quality assurance and data import/export. The product’s flexible architecture provides the level of scalability needed to manage complex studies with little performance degradation.
Market Acceptance: Our Clintrial product is in use at 8 of the Top 10 pharmaceutical companies. The Clintrial product’s largest trial, to date, involved the management of over 17 million data points.
WebSDM™ – Applied Data Standards
Our data submission management product, WebSDM, provides a user-friendly environment for browsing and reviewing standards-compliant (CDISC SDTM format) clinical trial data. The WebSDM product allows users to load, correct and browse SDTM data, using a variety of graphical formats. Using WebSDM, companies can feel comfortable with their FDA submissions.
Market Acceptance: The WebSDM product was built under a cooperative research and development agreement with the FDA, and has been in use at the FDA since 2004. As an FDA-standard review tool, the WebSDM product has been used by many leading pharmaceutical companies to review and prepare their data for submission.
CTSD™ – Clinical Trials Signal Detection
Our CTSD product allows clinicians, medical monitors and clinical safety scientists to assess drug safety and to detect potential problems early-on by providing a set of powerful graphical and analytical tools. The product’s unique screening feature is designed to identify the situations in which subjects on study treatment experience adverse events (including clinically significant lab results, ECG anomalies, etc.) at a rate higher than the comparator treatment. Tracking tools integrated into the system help to assure that signals can be monitored through to resolution, providing a basis for a more comprehensive statistical, medical and management review.
Market Acceptance: Available since early 2006, CTSD is currently in use at the FDA and several top pharmaceutical companies. The CTSD application earned the Bio-IT World Best-of-Show Award at the Bio-IT World Conference in June 2006.
Empirica™ Signal – Quantitative Signal Detection and Management
Life sciences companies and regulatory agencies use our Empirica Signal data mining solution to detect safety signals in databases of adverse event reports. The product applies classical and Bayesian data mining techniques against in-house or public databases (e.g. FDA AERS and VARES and WHO Vigibase) to produce statistical scores that demonstrate potential safety signals for further analysis. The product’s Signal Management module provides a structured environment for making online assessments of potential signals, for prioritizing their work, and for tracking and documenting signal evaluations as part of ongoing pharmacovigilance activities.
Market Acceptance: The Empirica Signal technology is currently used by 7 of the top 10 pharmaceutical companies, as well as safety groups and regulatory agencies including the U.S. FDA and the U.K. MHRA to identify unexpectedly frequent combinations of drugs and events, and to organize and analyze patterns in safety data. This product earned a 2005 Bio-IT World Best Practices Award.
Empirica™ Trace– Adverse Event Reporting
Our Empirica Trace application provides near real-time visibility of product safety data, facilitating compliance with regulatory reporting deadlines and more timely identification of therapeutics that may pose risks to patients. Empirica Trace is designed to be used for drug, biologic, vaccine and medical device product safety monitoring. The product enables users to produce standard reports and create custom reports via Empirica Trace reporting capabilities which are tightly integrated with the Cognos ReportNet product. The Empirica Trace platform is highly scalable and can be used to manage hundreds of thousands of adverse event reports annually.
Market Acceptance: The Empirica Trace solution has been used by pharmacovigilance professionals to manage adverse event data, and to monitor and report on product safety since 1993. The Clintrace solution meets regulatory requirements for reporting throughout the world, including the U.S., Europe and Japan.