Medidata Solutions, a global provider of electronic clinical data
capture, management and reporting solutions, today announced its
partnership with Fast Track Systems, Inc., a provider of clinical
trial design software and professional services. The companies have
entered into a multi-year agreement to integrate Fast Track's
TrialSpace Designer(R) (TSD) study design software with Medidata
Rave(R), the industry leading EDC platform.
Traditionally, study design and EDC study build have been thought
of as separate activities. Sponsors have prepared protocols and
statistical plans using simple desktop applications that lack the
intelligence to identify potential inconsistencies throughout these
lengthy documents. In addition, EDC roll outs have required
significant implementation and validation activities for each study.
The combination of TrialSpace Designer and Medidata Rave integrates
these two previously separate activities and creates a seamless flow
of information from initial study design through electronic case
report form (eCRF) build and beyond.
Customers leveraging the combined solution can optimize their
clinical development practices through Fast Track's easy-to-use design
tool to seamlessly create both study documents and standards-based
study data models. Expanding on Rave's existing capabilities around
rapid study build and deployment, this partnership allows automatic
implementations of CRFs and workflow for studies based on electronic
study design standards.
"As the industry struggles to contain rising development costs,
the combined solution of TrialSpace Designer and Rave will reduce
costly inefficiencies and expand execution capacity by automating many
complicated study start-up processes," said Ed Seguine, CEO of Fast
Track Systems, Inc. "The capability of TSD to initially capture and
model complex trial design information perfectly complements Rave's
ability to efficiently configure and manage this data throughout the
execution lifecycle. The vision of a truly integrated study design and
execution suite is indeed a reality."
With this partnership, sponsors will be able to use TSD to define
a clinical trial protocol, statistical plan and operational details,
then export the information according to the CDISC operational data
model standard. From there, the exported data can be used to set up an
EDC-based trial using Medidata Rave's Architect Loader, an XML-based
study build tool.
"Fast Track's break-through protocol authoring and study design
technology integrated with Rave will allow us to deliver our customers
an optimal solution for executing clinical trial operations from study
design through data capture and clinical data management," said Glen
de Vries, CTO of Medidata Solutions. "We've already achieved a 50
percent reduction in study configuration requirements, and with our
continued work together combined with rapid reusability offered by
Rave's Global Library, we expect to reduce the workload for study
deployment even further."
About Fast Track Systems, Inc.
Fast Track's products reduce cost, increase compliance, and
improve productivity by solving problems associated with the
operational aspects of clinical trial design and execution. TrialSpace
Designer ensures greater consistency and transparency in trial design
by capturing study design information as reusable data that can be
utilized by other clinical systems and leveraged for related purposes.
Grants Manager and CROCAS draw from over 25,000 finalized protocols,
240,000 negotiated grants, and 4,000 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.
About Medidata Solutions Worldwide
Medidata Solutions helps the world's leading pharmaceutical,
biotechnology, medical device and research organizations maximize the
value of their clinical research investments. Innovative process
design, technology and services streamline clinical trials by
providing early visibility to reliable clinical data - the lifeblood
of every research organization. Working with companies and
institutions both large and small, Medidata Solutions helps clinical
researchers safely accelerate the process of bringing life-enhancing
treatments to market - on six continents and in more than 80
countries. Medidata Solutions brings significant value to its broad
client base with deep clinical experience and expertise in more than
20 therapeutic areas, projects in Phase I, II, III, IV, registries and
surveillance, and studies with thousands of investigators and
tens-of-thousands of subjects. For more information, please visit
www.mdsol.com.
