Life sciences generate large volumes of clinical trial data and other documentation, which may be managed more effectively with this software module
First Consulting Group has launched FirstDoc Clinical Trials, the
fifth module in the company's enterprise content management
(ECM) solution suite, at the DIA EuroMeeting in Prague, Czech
FirstDoc offers life sciences enterprises a flexible
single foundation from which to manage clinical information,
documentation and workflow.
FCG developed its most recent ECM
module to respond to a functional need that, it says, has yet to
be addressed by the IT vendor marketplace.
R and D remains the
area of major IT spend within the pharmaceutical industry -
estimated at US$13.2 billion in 2002 - yet very little of the
investment has addressed companies' clinical documentation
and data challenges.
FirstDoc Clinical Trials is one of the few
solutions tailored to manage clinical documentation throughout
the trial process and help companies overcome some of these
FCG's most recent ECM contracts have included
FirstDoc Clinical Trials.
The company anticipates that many of
its 40+ global pharmaceutical clients will adopt the Clinical
Trials module as they roll out an enterprise-wide solution in the
"FirstDoc Clinical Trials is the cornerstone
of FCG's eClinical roadmap, which aims to reduce clinical
trials time by as much as two-thirds - consistent with estimates
the analysts have projected for those companies that leverage
clinical automation tools," said Mark Vermette, director of
clinical solutions for FCG's life sciences practice.
"Currently, 95% of clinical trial information is
paper-based, which results in clinical trial managers making slow
and sometimes inaccurate decisions based on old data.
solution delivers real-time management and status reporting of
received clinical documents to researchers, prompting fewer
errors and faster drug discovery and development.
release of our FirstDoc Clinical Trials solution sets the
foundation for clinical documentation and data set storage and
management for that vision".
FirstDoc Clinical Trials allows
clinical managers to make real-time decisions about trials,
thereby enabling clinical departments to contribute to regulatory
submissions in a fraction of the time previously required.
FirstDoc's foundational information infrastructure,
companies can now gain competitive advantage through the
knowledge collected and shared throughout the trial, improving
the client's ability to launch products faster and more cost
Both web and client/server enabled, FirstDoc
Clinical Trials streamlines trials by managing and organizing all
documentation, trial master file (TMF) documents and case report
forms (CRF), created and collected during the planning and
execution of clinical trials.
The company's ECM solution
suite anchors FCG's array of consulting, technology, and
outsourcing services that help life sciences leaders improve
return on investment at all phases in the drug development
FirstDoc is said to be the only solution suite in the
life sciences industry that offers full enterprise functionality
in an out-of-the-box, regulatory compliant solution.
modules in the FirstDoc solution suite cover all stages of the
drug development lifecycle.
In addition to FirstDoc Clinical
Trials, they include FirstDoc R and D, FirstDoc GMP
(manufacturing), FirstDoc M and S (marketing and sales) and
FirstDoc MedInfo (medical information).