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Applied Clinical Trials
A case study of the Duke Clinical Research Institute's implementation of Oracle's CTMS shows flexibility is vital.
Category: ARO (Academic Research Organization)
Executive: Kevin Jarrell, Project Leader
Headquarters: Durham, NC
Business Goal: To further integrate CTMS into the business process
Number of Employees: 950; 300 for CTMS
In late 2003, the Duke Clinical Research Institute (DCRI) purchased the Oracle (Siebel) Clinical Trial Management System (CTMS) because the organization’s previous CTMS solutions were no longer meeting the business need. “The first pilot project was in October 2005 and the second in March 2006. Both pilot projects were successful and the decision was made for all new projects to use CTMS, starting in January 2007.” Since then, the project has continued with major and minor releases occurring every three or four months.
“We identified the need for a common, standardized approach,” said Kevin Jarrell, Project Leader at the DCRI. “To meet this need, we wanted to move to an enterprise-class CTMS. An additional challenge for the DCRI was system access, as many of our users are located remotely or travel significantly. This again made our decision a little easier because the Oracle CTMS is Web-based and can be accessed from any computer over the Internet,” explained Jarrell. The DCRI’s user base consists of 300 employees. This includes 150 traveling or home-based CRAs and Project Leaders. The balance is comprised of in-house Clinical Trial Assistants (CTAs), Project Lead Assistants (PLAs), Safety, Regulatory, and Site Start Up specialists.
Now live for over two years, Jarrell indicates the biggest benefit of the system is its flexibility. Specifically, being able to implement a standard framework to track milestones, training, conversations, documents, etc. while giving the project team the flexibility to choose which one and how many of these to track. “We worked very hard to get the software to fit our business rather than the business fit the software,” explained Jarrell. “And the CTMS does give us a competitive edge.”
While the DCRI does not have all Oracle modules for Safety, RDC/EDC, and IVRS, Jarrell says that part of the CTMS’s attractiveness is its ability to integrate with other products.
A Different Mindset
The DCRI was created from its former Duke Databank for Cardiovascular Disease in 1996 and has become a recognizable name for its acumen in clinical trials. That is during a time when many academic medical centers (AMC) were losing dollars in industry-sponsored clinical trials, a reported drop of approximately 55% from 1991 to 2006.
As an academic research organization (ARO), the DCRI both competes against CROs, as well as works with them. As an example, the DCRI could be responsible for managing sites in North America, and collaborating with a CRO to manage sites in Europe on one project. On another project, the DCRI could be competing for the same business.
“The uniqueness of an ARO, is that we are competing against CROs, offering the same or more services; however, as an ARO we are doing it with a more academic mindset,” explains Jarrell. Having worked many years at a CRO, Jarrell says working at the DCRI is different. “It’s refreshing. There are many physicians that attend the meetings and it’s definitely more about medicine and science here,” Jarrell told
Applied Clinical Trials