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Special Issue 
· Best Practices Making Perfect
· Millennium's PARIS Illuminates Pathways
· The BRAIN Behind BCM's Clinical Trials
· Solutia Streamlines Route from Lab to Production
· Discovery And Development Participants
· Clinical Trials Participants
· Drug Manufacturing 
· The Technology Behind Best Practices
· Technology Providers
July 15, 2003 | At any given time, the Baylor College of Medicine has more than 2,000 active clinical trials under way among its seven Houston-area hospitals. All these studies are monitored by the Office of Research, which is responsible for enforcing regulations, coordinating communication between the investigators and the six Institutional Review Boards (IRBs), and educating research staff about compliance requirements.

When BCM's protocol review and approval processes were paper-based, they were subject to myriad snags — e.g., the wrong consent form submitted with a protocol; misfiled adverse event reports; stacks of paper carted from place to place for signatures; months of waiting before investigators receive approval to run a study.

In 1999, the administration decided to pursue a paperless solution, which the IT staff at Baylor's Office of Research (OOR) elected to develop themselves. The project was initially slated to take six months and was budgeted at $100,000. In fact, what ultimately came to be called the Biomedical Research and Information Network, or BRAIN, took two years to build and cost BCM $1.5 million. Yet no one doubts the value of the investment.

BRAIN supports the entire life cycle of a protocol, from all the tasks and communiqués associated with a protocol's initial creation and review, through the acknowledgment of adverse event reports, to the submission and review of amendments, renewals, and closure requests. In particular, developers sought to automate the most mundane and paper-intensive points in the life cycle, ultimately aiming to eliminate the need for paper entirely.

To manage the flow of documents manually at large clinical trial sites, research departments and institutional review boards (IRBs) must follow a process that can be slow, resource-intensive, and error-prone. Typically, process improvement focuses on areas where the output is more obvious: clinical data access, for instance, or maximized financial return. Control of regulatory documents rarely gets the limelight.

Baylor College of Medicine, however, developed a system that overhauled and automated the management of protocol administration and IRB oversight — procedures essential to getting clinical trials off the ground quickly and ensuring regulatory compliance. "BCM's system is comprehensive, innovative, and solves several major problems faced by academic centers and trial sponsors," says Stephen Fogelson, director of clinical research at Clinquest, and a judge for the Clinical Trials category of Bio·IT World's Best Practices Awards.

Further explaining why BCM's BRAIN system took top honors, Fogelson says: "While improving the ability to manage document flow, the system also improves quality and accuracy of document generation, and ultimately makes BCM a more attractive venue for study sponsors to place their clinical trials."

— Editors

With BRAIN, principal investigators complete protocols entirely online and obtain signatures electronically. When the last signature is obtained, BRAIN sends the protocol automatically to the OOR and assigns it to a committee. Review can commence immediately — again, online — without OOR staff having to make a single photocopy or route a single piece of paper.

BCM has seen at least fourfold decreases in turnaround time on key reporting and documentation tasks. BRAIN handles regulatory language and paperwork requirements automatically, reducing clerical errors and enabling board members to focus on the science behind the protocol rather than bureaucratic minutiae. BRAIN has even upgraded job descriptions, transforming BCM's Office of Research analysts from clerical workers to regulatory experts who play a critical role in protocol review.

Moreover, clearing out the paper has enabled BCM to adjust and refine its collaborative processes. There is more effective, electronic data sharing between the institution and pharmaceutical sponsors — not just to speed clinical trials, but also to ultimately help patients. Investigators and IRB members, for instance, can now assess adverse events across studies in real time.

Adapted from company entry 

For reprints and/or copyright permission, please contact  Jay Mulhern, (781) 972-1359,