Software Update: Clinical trials software offered free of charge

Software company has philanthropic goals

(Editor’s note: In this issue, Clinical Trials Administrator begins with this issue a periodic series on clinical trials software, looking at its use, potential, and availability. The software featured in this issue is eCTM, created by CyberMedica Foundation of Kennebunkport, ME.)

The CyberMedica Foundation began in the late 1990s as a for-profit company created with venture capital money as a business that would create a framework for the drug discovery process from the beginning to end.

When that first effort fell victim to the dot com and technology stock market crash a few years ago, CyberMedica Foundation was formed by the original chief technology officer Robert Stewart, who purchased the intellectual property and assets of the for-profit entity to establish the nonprofit foundation, says Stewart, who now is executive director of CyberMedica Foundation.

"We’re entirely privately funded and have a membership structure based on the size of an organization and whether or not the organization is for profit or nonprofit/academic," he says.

Stewart’s motivation in starting the foundation was his experience of losing a younger brother to a rare disease, which has convinced him of the need for faster research to produce faster cures. His brother died at age 9 of rhabdomyosarcoma, an aggressive cancer.

"He spent a lot of time at the National Institutes of Health in Bethesda, MD, and was on experimental drugs for his chemotherapy," Stewart recalls. "He was pronounced in remission, and then the cancer came back and took his life."

After doing his own market research, he was convinced there was no unified industry standard for the drug discovery process, and that the current process was inefficient and complex.

"As I came up to speed with industry, I gained an appreciation for how complex the cycle was and what influences are in that cycle," Stewart says. "It became my mission to develop this software, and when it became obvious the for-profit entity wasn’t going to finish the job, that’s when I took on the project personally, pouring every penny I have into getting it to this point."

Since his and the foundation’s goal is to give the research industry a means for making the clinical trial process more efficient and faster, he decided to offer the software for free. This way, small institutions and clinical trials programs also may benefit from its technological assistance.

The software programs were made available to the public in July 2004, and there already are institutions using the system, which includes modules for funding and grants management, peer review publishing management, research and development collaboration, IRB management, as well as clinical trial management, is available for free use by any organization, whether it’s a member or not. Each module can be integrated with the others, so an institution could use all of them in a way that would create data management efficiencies, Stewart reports.

"You could use just one module and not the others," he says. "However, I don’t think you could get the same level of benefit as if you used all of the modules."

Another reason why Stewart decided to offer the software for free is because open-source technology permits each user to contribute toward improvements that will be built into modifications and revised versions of the software, he says.

"The application itself in five modules are going to change over the course of the next 20 years as technology changes," he explains. "This approach allows you to contribute your changes to the foundation’s efforts, so updated modules will contain modifications you’ve made and contain modifications that other people have made, improving everybody’s experience dramatically."

The best practices and approaches are integrated into the standards body, and each institution will not have to spend considerable time and resources in implementing and accommodating the software, Stewart adds. "The opportunities for efficiency here are astounding."

For example, it’s possible that the integrated software modules will help an IRB’s adverse event reporting taken into account the sensitivity of private data and the CFR Part 11 security requirements and propagate that information immediately, he notes.

"The integration of the modules will enable adverse event findings discovered during the clinical trial process to be reported directly into the IRB for immediate action," Stewart says. "This can have a tremendous acceleration benefit."

The system will require configuration, but a technology department could handle that, and if an office needed assistance, CyberMedica does have support staff available at a cost-recovery basis that includes a day rate for time and materials, Stewart says.

CyberMedica’s system was created with peer review input. "A broad consortium of industry people sat side-by-side with software developers," Stewart says.

The clinical trials management software, called eCTM, can be used in this way:

Make certain hardware and software are adequate. To use the software, an clinical trials office will need a server of Pentium class with 256 megabytes of RAM and enough hard drive space to hold data, Stewart explains.

The next step would be to go to the IBM link on the CyberMedica web site to download the latest version of Lotus Domino Server from IBM, he says.

Download eCTM. A clinical trials coordinator could download just eCTM or all of the modules at www.CyberMedica.org, and they will automatically install in the appropriate directories, Stewart says. "Then you need to go to your web browser and connect your box to the network and then log in," he explains.

Documentation and training manuals also could be downloaded for free.

Ask questions: Once everything is downloaded, the next step is to write down questions and to try to identify gaps in what the software offers and what is needed, Stewart suggests.

"Once you define what those gaps are, then you would either talk to your own IT department to figure out if there is a Lotus Domino administrator on staff, who could help you make modifications, or you could contact the CyberMedica Foundation to create a statement of work from the notes," he says.

Input data: Once the installation problems are resolved, it’s time to key in the research data, Stewart says. "All the data recorded into the system is sacrosanct and can’t be changed. You can create modifications to it, and these are only made by people who are appropriately authorized to do so."

As a clinical trials coordinator creates a protocol, the software system will create data collection forms for the trial, he adds. "If you go to the web site and click on demonstration’ for an IRB module in particular, there is a demonstration video you can download and watch. There’s a video demonstration of software being used for management of an IRB."