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 Republic.
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 issues.
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 coming years.
"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.
"Our solution delivers real-time management and status reporting of received clinical documents to researchers, prompting fewer errors and faster drug discovery and development.
"The 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.
With 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 effectively.
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 lifecycle.
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.
The five 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).
