Key business optimization features and operational enhancements reduce complexities and speed study startup
SAN FRANCISCO, October 17, 2017 -- goBalto, Inc., the leading provider of cloud-based clinical study startup (SSU) solutions, announced today its latest release of goBalto Activate. The third major release of 2017 offers new features that further accelerate clinical study startup.
SSU is an array of activities performed at the outset of studies, including: investigative site selection and initiation, regulatory document submission, contract and budget negotiations, and enrolling the first subject. The process of initiating clinical trials remains unwieldy, challenging, and often behind schedule, making SSU one of the poorest performing aspects of clinical trials. At a time when SSU remains a perpetual bottleneck, leading companies are positioning themselves ahead of the curve by embracing solutions that confront these real challenges, thereby emphasizing differentiation and operational efficiencies.
New APIs and functionality in the release allow for the exchange of alert or task information between Activate and the Shared Investigator Platform (SIP), and other industry site portals.
"The enterprise APIs enable other systems or transformation layers to interact with the application data in much the same way that a user would," said Sujay Jadhav, goBalto's CEO. goBalto's proven integration points encompass the eClinical suite and business applications (e.g., CTMs, CRM, eTMF, data warehouses) with key integration components (i.e., data staging, business rule compliance, target data staging and API processing) provided to ensure a seamless and successful integration.
"The integration of Activate with SIP is key to ensuring improved efficiencies across the clinical trial process and compliance with evolving industry standards," said Jadhav. "Activate workflows aid global regulatory and SOP compliance, accelerating site activation, leading to greater cost savings and faster market entry."
The Configuration Designer functionality in Activate provides a self-service configuration wizard for workflows, providing the flexibility needed to rapidly respond to dynamic regulatory and SOP changes for studies, currently in-progress or planned.
"The enhancements to the application interface, contract management functionality, and others of this most recent release improve overall usability and ease of adoption," stated Lorena R. Gomez, Director, Global Study Start Up & Essential Documents, Allergan. "It's clear that goBalto listens to their customers' feedback and incorporates it into subsequent enhancements."
With over 300 pharma and CRO companies benefiting through a networked model using Activate to manage, track, and complete study startup tasks in over 2,000 studies, utilizing over 70,000 sites, in 70+ countries, goBalto has the largest industry-proven set of country workflows and associated performance metrics. Standard 'out-of-the-box' country specific regulatory business process workflows allow for quick site activation, leading to greater cost savings and faster market entry, making valuable therapies available to patients sooner.
"Today, our SSU platform is embedded into the business processes of leading life science organizations, that take advantage of new releases to enhance overall value. This release illustrates our commitment to our customers as we enhance interoperability with leading portals, and provide new functionality to tackle entrenched pain points in SSU," said Jadhav. "This release reinforces goBalto's leadership position as we continue to provide next-generation, industry proven study startup solutions, which are key to stemming inefficiencies endemic in industry."