The life sciences industry has recognized study startup as one of the worst performing areas in clinical trials. Many organizations struggle to control costs and resources associated with ramping up clinical trials. It is generally a manually intensive and highly inefficient process. The multistep process of collecting, reviewing and approving regulatory documentation is cumbersome, resulting in millions of dollars of waste per client, and can lead to delays in findings and ultimately, approvals.

Innovation

There is intense pressure to speed clinical trials and restrain costs, but inefficiencies tied to complicated protocols, globalization, and paper-based methods have stalled these efforts. The current status of clinical trials has encouraged stakeholders to embrace cloud-based solutions such as clinical trial management systems (CTMS), and the electronic trial master file (eTMF), but one key bottleneck, study startup (SSU), has been largely overlooked.

The processes involved in study startup are complex and rarely performed via a single function with the Sponsor/CRO organization typically requiring the interaction of multiple people at the individual sites such as contracts, regulatory and finance, in addition to the coordinator and Principal Investigator.

Existing systems (CTMS, TMF, Study/Investigator Portals, Excel, etc.) support each of these functions in silos—the ability to bring together the collective institutional memory and the facilitation between systems and team members is critical—representing an unmet need.

Many of the steps involved in SSU create delays, but the advent of purpose-built cloud-based technology can make a disruptive impact. An SSU application is a critical additional to the ongoing automation of clinical trials, and has the promise of cutting costs by shortening timeframes for developing therapies needed by patients worldwide.

Early adopters are leading this disruptive change. Industry leaders in clinical trials continue to show strong adoption of our flagship product, goBalto Activate. Our solution is now being used in hundreds of studies in multiple countries at over 18,000 sites—enabling medicines to get to those in need faster.

Ross Pettit

ROSS PETTIT
SVP
Clinical Development Operations at Infinity Pharmaceuticals
“Many of the steps involved in study startup create delays, but with the deployment of goBalto Activate, a proven, purpose-build cloud-based study startup solution we can make a disruptive impact. Our partnership is critical to our goal of achieving automation in our clinical trials processes and our mission of cutting costs by shortening timeframes for developing therapies needed by patients worldwide.”

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