Phase Forward Becomes CDISC Registered Solution Provider
Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced that it has obtained Registered CDISC Solution Provider (RCSP) status from the Clinical Data Interchange Standards Consortium (CDISC) for supporting the organization’s standards throughout its product suite and service offerings. CDISC is widely embraced by regulatory agencies, technology providers, and drug companies as critical to developing software tools and services around standards which provide for the flexible exchange of clinical information necessary for drug development and approval. As one of a select number of electronic data capture (EDC) vendors acknowledged as an RCSP, and a long-time member of CDISC, Phase Forward offers the widest range of CDISC registered products to customers who are seeking improved efficiency in their clinical data management process. By obtaining certification for three unique clinical data standards, Phase Forward has affirmed its industry leadership by providing independently reviewed solutions designed to meet the highest standards in the clinical data management industry.
The mission of CDISC is to develop and support global, platform-independent data standards that facilitate system interoperability to improve medical research and related areas of healthcare. CDISC promotes standards consisting of data-model components designed to support data flow in clinical trials, the goal of which is greater process efficiency across clinical applications. Clinical data standards also drive interoperability so that clinical research data files and support information can be transported and shared among multiple groups independent of the platform on which it resides.
Phase Forward’s product suite is now certified as supporting three separate CDISC data models, including:
— Study Data Tabulations Model (SDTM), as supported by its Clintrial(TM) clinical data management and Clinical Integration Solution products;
— Laboratory Standards Team model (LAB), as supported through its Clintrial Lab Loader product; and,
— Operational Data Modeling (ODM), as supported by the company’s client consulting services.
A long-term member of the CDISC consortium, Phase Forward was recognized for adhering to the CDISC Code of Ethics, having a positive overall reputation for the clinical research services it provides, and delivery of a commercial product based substantially on CDISC standards which was reviewed by at least two CDISC Board members. The company also received special mention from CDISC for achievement in five separate areas including:
— Incorporation of the CDISC Study Data Tabulation Model (SDTM) and Laboratory Standards Team (LAB) with its Clintrial clinical data management solution including a tool within Lab Loader for mapping LAB files into SDTM;
— Conducting CDISC workshops for users of Clintrial;
— Providing support for CDISC in Japan, for in-country users of its products;
— Serving as the first company to attempt an E2B – SDTM mapping (Serious Adverse Event capture in EDC and transfer to safety database); and,
— Liaison with the NHS, the UK health service, regarding Health Level 7 (HL7) standard in medical records, and planning for future data transfer.
“Phase Forward’s mission is to provide solutions that help our customers bring their drugs and therapies to market with greater efficiency and safety,” remarked Bob Weiler, president and chief executive officer of Phase Forward. “CDISC certification recognizes that we are building our products on a foundation based on industry standards. I believe this underscores our ability to provide market-ready solutions that offer flexibility for clinical data management and safety, with well-designed interoperability so that our clients can meet their current and future needs.”
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 in electronic data capture (EDC), clinical data management (CDM), and adverse event reporting (AER) to help pharmaceutical, biotechnology, and medical device companies bring needed drugs and therapies to market faster and more safely. Lincoln Technologies, acquired by Phase Forward in August of 2005, delivers solutions for pharmacovigilance, data standardization, and safety signal detection. The combined companies’ products and services have been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial study participants at over 220 organizations and regulatory agencies worldwide including: AstraZeneca, Biogen Idec, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, FDA, GlaxoSmithKline, Guidant, MHRA, NIH, Procter & Gamble, Quintiles, Sanofi-Aventis, Schering-Plough Research Institute, and Serono. Additional information about Phase Forward is available at www.phaseforward.com .
