SAN FRANCISCO—Preliminary findings from the goBalto Inc. 2015 Global Study Startup Survey uncovered significant gaps in the industry’s ability to efficiently manage document workflows and activities associated with starting clinical trials.
The survey found that industry leaders were continuing to adopt ‘best of breed’ cloud-based eClinical solutions, such as clinical trial management systems (CTMS), electronic data capture (EDC) and electronic trial master file (eTMF); however, even the latest releases of these applications fell short in addressing one of the most inefficient and costly bottlenecks of clinical trial conduct—study startup (SSU).
The process of initiating clinical trials continues to remain cumbersome, challenging and often behind schedule, making SSU one of the poorest-performing aspects of clinical trials.
“Excel is still the mainstay in managing clinical trials, and while a few have tried to use existing eClinical or document management systems for SSU, they have fallen short,” said Sujay Jadhav, goBalto’s CEO. “Only a purpose-built SSU solution capable of handling complex regulatory/SOP workflows is able to tackle the complexities associated with starting clinical trials, providing true efficiencies via cycle time reductions.”
Unfortunately, the use of Microsoft Excel is still omnipresent. Over two-thirds of sponsors and CROs use Excel for site selection and evaluation, with the majority of sponsors (93 percent) and CROs (80 percent) using Excel for site feasibility. Moving further into the clinical study life cycle, activation, over 80 percent of sponsors and CROs still use Excel for tracking of SSU processes. Ironically, three of the top sponsor/CRO pain points were directly related to the limitations of using Excel for SSU, namely lack of operational oversight with no availability of real-time reporting on clinical trial status (or CRO performance), lack of project management standards (particularly for activities impacting milestones along the critical path) and lack of integration of systems for site selection, feasibility, activation and document management.
When asked about the reasons for this enduring situation, goBalto’s founder and president of business development, Jae Chung, is frank: “Companies are encumbered by their spreadsheets, but goBalto’s cloud-based system is like moving from manual tax preparation to TurboTax. And many people [and companies] are averse to change.” Sometimes, he notes, it’s a question of prioritization. Chung goes on to add that clinical trial start-up is “one of the last frontiers of innovation.” The goal is to increase margins and the bottom line, so the incentive for change is there.
Business intelligence initiatives continue to be top sponsor and CRO priorities, as executives demand greater visibility into trial data at a much faster pace. Manually prepared data is often too old to reliably represent status, and readily proving you’re on track is still an ongoing challenge. Instead of traditional one-dimensional, static reports, sponsors and CROs desire interactive, real-time answers about study startup statuses.
“True business intelligence is the ability to proactively identify and resolve bottlenecks in realtime, instantly view statuses, quantify your team’s performance and discover meaningful patterns in your clinical study startup data,” said Jadhav. “Today’s industry leaders in clinical trials recognize that good data increasingly translates to a competitive advantage.”
goBalto develops next-generation solutions that simplify and accelerate clinical study startup in the pharmaceutical, biotechnology and medical device industries. The management team has over 100 years of combined experience in the life-sciences industry and enterprise software implementation. goBalto has worked for such companies as Amgen, Genentech, Quintiles, Roche, Johnson & Johnson and Model N. With what it calls “a proven commitment to customer success, disruption and study startup optimization,” the company aims to change the way leading global pharma and CRO customers approach their business processes. goBalto is based in San Francisco, with satellite offices in Pennsylvania and Singapore.