SOURCE: Fast Track Systems

September 26, 2007 15:03 ET

Fast Track Systems Announces ODM Certification and Name Change for TrialSpace Designer XCP™ Application

Extensible Protocol Design Tool to Be Featured at CDISC 2007 4th International Interchange in Bethesda, Oct. 1-5

CONSHOHOCKEN, PA--(Marketwire - September 26, 2007) - Fast Track Systems, Inc., a pioneer developer of tools for clinical trial design collaboration and communication, announces successful ODM 1.0 compliance certification by CDISC of its core clinical trial design and protocol authoring tool, TrialSpace Designer XCP. The official certification means users of Designer XCP can be assured that the application is fully compliant with CDISC standards, allowing vendor-neutral, seamless data interchange among various clinical information systems. Such certification is hard-earned -- Designer XCP is just the third application to be ODM-certified and is the only commercial tool that can simultaneously create both the critical study documents and the related ODM output to populate EDC databases, trial registries, and other downstream systems.

"The great hurdle to CDISC adoption has always been the need to actually create standards-based information as part of the natural workflow; Designer XCP overcomes that hurdle," commented Ed Seguine, chief executive officer of Fast Track. "Achieving ODM certification is an unambiguous statement of our commitment to the open-source standards CDISC has developed. This technical accomplishment is also a further validation of the moves by several Top 10 pharmaceutical firms to implement comprehensive, standards-based eClinical strategies."

"The ODM 1.x compliance certification is certainly an important milestone in the development of Designer XCP," noted Peter Abramowitsch, chief technology officer of Fast Track. "Equally important is the confidence that our clients should have that, as standards evolve, Designer XCP will continue to be ODM-compliant. To that end, the current release of Designer XCP is also capable of capturing and exporting the even more sophisticated trial design information related to the upcoming ODM 2.0 release, as well."

Previously known as TrialSpace Designer, the core application has been renamed as TrialSpace Designer XCP (eXtensible Clinical Protocol) to better reflect the chief benefit of the tool, which is to create an extensible clinical protocol. The extensible clinical protocol is the set of information used to create the document known as the clinical research protocol, but it is also the information source used to create related regulatory and operational documents (e.g. the statistical plan, informed consent, etc.) and to populate execution systems without the need for continuous rework, multiple interpretations, and manual data entry. The TrialSpace designation reflects the broad information platform that underlies all of Fast Track's products and services and has proven reliable in implementations with over 100 clients over the last five years.

Fast Track Systems will be demonstrating the data-interchange capabilities of Designer XCP at the CDISC 2007 International Interchange in Bethesda, Maryland on October 1st during the End-to-End Workshop. Fast Track Systems will also be discussing extensible protocols during the conference sessions on October 2nd and will be available in the Exhibition Booth area as well.

ABOUT FAST TRACK SYSTEMS, INC. -- Fast Track's products reduce cost, increase quality, and improve productivity by addressing inefficiencies and information asymmetries in traditional clinical trial-design and execution processes. TrialSpace Designer XCP™ is the first comprehensive, standards-based clinical protocol design, collaboration, and communication solution capable of capturing study design information as reusable data that can be seamlessly integrated into other information systems and disseminated to regulators. Grants Manager and CROCAS draw from over 25,000 finalized protocols, 250,000 negotiated grants, and 4,500 CRO contracts to ensure that subscribers understand the true cost and compliance consequences when negotiating clinical agreements. Visit www.fast-track.com for more information about our products and services.