By Allison Proffitt 

 

April 23, 2014 | Things have changed in the clinical trial landscape since GoBalto won the Judges’ Prize at the 2010 Bio-IT World Best Practices Awards for Tracker. 

 

“The original solution was a directory that was all about connecting the CROs and the sites and sponsors and about providing improved transparency information,” founder Jae Chung said. Then, Chung described the platform as “Yelp for the drug development industry,” giving clinical trial sponsors unprecedented intelligence about their would-be partners around the world. 

 

Today, though, GoBalto’s focus is on processes. 

 

“I think the idea of providing visibility and transparency of information in terms of partners is still part of the value proposition. Where we’ve re-directed our efforts is more about providing visibility around processes… We felt that there was a much more interesting problem around providing visibility around actually how folks are doing study start up. It’s increasingly one of the bottlenecks in study conduct.” 

 

Since 2010, the company has taken on new funding and new leadership as well. In late 2012, the company raised a $12 million round of venture financing, led by EDBI, the global investment arm of Singapore's Economic Development Board, with participation from new investor Qualcomm Life Fund. In December 2013, committed entrepreneur Sujay Jadhav took the reins as CEO, and Chung took more focused responsibility for corporate strategy, sales, and business development as President. 

 

The new focus is evident in products as well. GoBalto’s Tracker product, for which the company won the award in 2010, is not highlighted on the company website. 

 

Study Activated

 

With its eye on processes, the GoBalto team just released a whitepaper outlining its Study Startup Maturity Model—a framework for categorizing how mature are a company’s study startup processes, people, data, and integration. The company interviewed 200 clinical operations professionals across 100 organizations and found that the vast majority of executives placed themselves on the “fundamental” or “laggard” end of the maturity scale, Chung said. 

 

Even if companies know they don’t have the maturity they need, they’re not sure what to do next, Chung said. GoBalto’s newest methodology and product combination hopes to tackle that hole. FAST is a set of proprietary methodologies to achieve maturity in study startup; Activate is a purpose-built cloud platform that helps implement the FAST method. 

 

The FAST methodology focuses on Finding and eliminating bottlenecks; Aligning study teams so everyone has the same information; Streamlining data accessibility; and global milestone and critical path Tracking. They are all good goals, but tricky ones to implement. 

 

The Activate platform includes more than 60 customizable country workflow templates and tracks progress in real time, so all members of the study team can pro-actively identify bottlenecks. The platform supports the DIA TMF reference model. 

 

The real time progress reports set Activate apart. Chung described CTMS (clinical trial management systems) and eTMFs (electronic trial master files) as good archiving tools, but not tools that drive the process. The Activate platform is intended to compliment and fill gaps left by existing CTMS and eTMF systems.