The Biomedical Research Alliance of New York (BRANY) today will launch a new software application to help investigators build their own study protocols for IRB approval.

Protocol Builder, a software tool with an iPad app version, is designed for investigator-initiated trials, often conducted at aca­demic research centers and hospitals, to help Principal Investigators simplify and speed the creation of better written protocols and dramatically reduce the time needed for IRB review.

“We talked to research leaders, IRBs, inves­tigators and users and kept hearing the same thing: there’s an unmet need for a better tool to create all kinds of protocols that could be used by both inexperienced and experienced writers of investigator-initiated protocols,” said Kimberly Irvine, executive vice president and chief operating officer of BRANY, a national organization providing clinical trial support services to academic medical centers, hos­pitals and investigators involved in industry-sponsored and investigator-initiated research.

“In some ways, this software tool is a paral­lel to TurboTax, which walks you through all the incoming tax filing processes and takes a lot of the guess work out,” she said. “We are providing all the information needed by a researcher on protocol development in a tool that also is intuitive and research-centered, with built-in links to many resources, includ­ing FDA information and FDA forms.”

The goal, Irvine said, was to create a solu­tion to protocol development that decon­structs a complicated process and makes it simple and robust.

Protocol Builder is a secure desktop application in the cloud that provides a step-by-step approach to building a protocol, starting with a series of 14 different protocol templates. The software also can help users determine which type of research template to select by asking the user, “Are you propos­ing research that involves a repository or a sample bank?” or “Is this an observational or interventional study?” Highlighted tool tips explain the different types of protocols, such as Investigational New Drugs (IND).

The software features a dashboard that allows users to easily open and close sections with capabilities that can automatically cap­ture summaries and synopses, plus a simple way of getting input from colleagues as part of the collaboration process.

“The ability to add content and save it also reduces errors of omission and provides greater accuracy with editing tools,” said Brian Flint, partner and managing director at Truth NYC, the software strategy and design firm that designed Protocol Builder for BRANY. “We allow multiple people to comment without changing the content—an important way for a supervisor and an advisor to collaborate.”

The software also includes time-saving editing features with sections for appendices, tables, abbreviations and symbols, and a check list to ensure all sections—including glossary, definitions and adverse events—are properly populated with data.

The iPad version allows protocol develop­ers to read and enter information but does not allow them to attach external information.

Flint said when the concept was in its early brainstorming stages, the three most sought-after features were:

• Writing investigator-initiated protocols in less time with less hassle and frustration
• Enabling investigators and institutions to write protocols that meet IRB require­ments, eliminating time-consuming revi­sions that can delay IRB review and study start-up
• Giving researchers more time to conduct the research as opposed to writing and re-writing the protocol.

Irvine said Protocol Builder’s desktop version will have an initial license fee ranging from $5,000 to $10,000 and a $750 user fee which, based on the quantity of users, will drop to $500-$600 per seat.

She said, “We really see a mixture of first-time researchers and more experienced investigators using it.”

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This article was reprinted from Volume 19, Issue 02, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »