Tracker aims to reinvent study startup process.
By DEBORAH BORFITZ
March 29, 2011 | Online portal goBalto.com is about to formally launch Tracker, the industry’s first web-based platform devoted to clinical study startup, inspired by the user-friendly “look and feel” of consumer-facing outfits like Amazon.com, Salesforce, and Facebook. Through Tracker, goBalto CEO Jae Chung explains, study managers will be able to painlessly initiate a study in three easy steps: create a study, invite investigators, and then start tracking tasks and documents through a single portal. Authorized site owners will also be able to log onto goBalto.com to fetch all relevant documents, from financial disclosure and 1572 Statement of Investigator forms to budgets and contracts. “Think of it as the consumerization of enterprise software,” he says. The do-it-yourself nature of the solution, which requires no complex installation or training, is credited in part to a crackerjack team of visual designers and engineers proficient in the cutting edge Ruby on Rails programming language.
The new interface is remarkably simple, displaying startup progress via pie charts and bar graphs as well as icons representing tasks and documents completed, in progress, and yet to start. Calendar pages display the days-to-start and days-to-end of the enrollment period. Study startup tasks are broken down into nine steps tracked per site and as a gauge of overall study progress. When one task is completed, users are alerted about what to do next.
“There’s a lot of integration between Tracker and our directory [of life science service providers],” says Chung. “Sponsors still want to find high-performing investigative sites.” The intelligence-gathering feature of the portal earned goBalto Bio•IT World’s Best Practices Judges’ Prize last year (see, “goBalto Grows Matchmaking Portal,” Bio•IT World, July 2010).
The newly redesigned platform will be streamed live via Ustream.com at the Partnership in Clinical Trials event in Phoenix on March 31, by which time Tracker is expected to have ten customers, says Chung. Thereafter, the application will be available to a subset of “early adopters and innovators” cherry-picked from a waiting list of 120 companies. By this summer, the product hits the open market with a 30-day free trial offer. Pricing thereafter will be on a per-study, per-month plan, with no up front fees and discounts for prepayment.
The beta version gets the thumbs up from Allan Valmonte, director of clinical operations at KAI Pharmaceuticals, a 20-employee organization giving Tracker a test drive on a phase IIa end-stage renal disease study utilizing 12 U.S.-based investigative sites. He notes that Tracker allows sites to download only the most recent version of a document, a key advantage over file exchange via email. It also expedites reporting on study progress to senior management. Rather than manually entering data into an Excel spreadsheet, metrics are automatically generated whenever he makes an entry on Tracker. “I just log into goBalto from my iPad while I’m sitting at a meeting and...the metrics appear, graphically indicating where sites are at for each startup phase. On a weekly basis, I can send a screen shot to upper management.” goBalto is currently developing a downloadable reporting feature for Tracker, he adds.
“I’m pleasantly surprised at the progress made [on Tracker] and wouldn’t hesitate to use it again,” says Valmonte. His chief concern is pricing, which goBalto has yet to disclose. Per his feedback to goBalto, Tracker now features automation tools so that the completion and approval of one document triggers the exchange of another without human intervention—a must, Valmonte notes, for studies involving more than 25 sites.
C3 Research Associates co-founder Margaret Warner-Lubin also deems Tracker “promising,” based on her first few weeks of experience with the platform on a 60-site phase II test of a diagnostic tool. She’s especially pleased it doesn’t require a “programming mindset,” as does another commercially available study management system being used in parallel. “I really like [Tracker’s] simplicity. I don’t have to drill down four or five levels to find information… [and] that makes me want to use it more.” Being a visual learner, she’s also grateful the “help” section includes videos.
Tracker could displace Excel within two years by virtue of its ability to capture real-time study startup metrics useful for study planning and budgeting purposes as well as holding sites accountable for their performance, says Chung. Currently available software solutions aren’t much help, he adds. Nearly all 150 recently interviewed sponsors, CROs, and sites consider currently-available software solutions “clunky, overpriced, and inaccessible.”
At the end of this year, goBalto will start taking on space currently occupied by Oracle, SharePoint, and Intralinks, says Chung, noting that Tracker will quickly evolve into a full-fledged study management tool. Staff size is expected to roughly double from 12 to 25 by this time next year, when Tracker subscribers are predicted to number 150.
This article also appeared in the March-April 2011 issue of Bio-IT World Magazine. Subscriptions are free for qualifying individuals. Apply today.