Global CRO utilizes study startup automation to reduce trial complexity and improve operational transparency
SAN FRANCISCO, March 28, 2017 -- goBalto, Inc., the leading provider of cloud-based clinical study startup solutions, announced today results from its ongoing partnership with INC Research (NASDAQ: INCR), a leading global CRO and pioneer in the implementation of goBalto's end-to-end study startup platform to accelerate delivery of Phase I to IV clinical trials for global biopharmaceutical customers. INC Research continues to optimize its clinical study startup process on a worldwide basis, leveraging goBalto's technology to start more than 220 studies in more than 68 countries to date.
"As one of the significant support technologies for our Trusted Process® trial management methodology, goBalto is integrated into INC's ecosystem and provides detailed visibility into the status of our site-based activities; improving operational delivery that leverages actionable data," said Jonathan Shough, Chief Information Officer, INC Research. "goBalto assists us in combining process improvements with broad integrations, a strategy that leverages 'best of breed' applications in the eClinical stack to realize gains in operational efficiencies, ultimately resulting in shorter timelines and cost savings for our customers."
Benefiting from goBalto Activate's robust library of country-specific workflows and management-based approach to site activation, INC Research initiates and manages thousands of investigational sites on a global basis per year. With its employees leveraging the Activate system worldwide, INC Research manages small to large complex studies ranging from a single country to up to 40 or more.
As a longstanding goBalto customer, INC Research uses Activate to efficiently manage the end-to-end start-up process for more than 150 pharmaceutical sponsors. This process, guided by INC's industry-leading Trusted Process® methodology, includes tracking and management of investigational contracts and budgets, regulatory submissions, regulatory green light and other advanced and complex start-up business requirements. INC Research has realized operational efficiencies by improving internal processes, enabling greater visibility into trial status, and improving delivery of critical information to study managers - thereby accelerating the start-up process and mitigating risks before they affect study timelines. As a result of implementing Activate, INC Research is seeing positive impact on productivity, as well as increased transparency of start-up progress for customers.
INC Research has integrated Activate with its eClinical data integration hub, improving data integrity and driving efficiencies across clinical systems. As an example, when the INC team completes specific linked activities in Activate, a workflow automatically transfers the information to the CTMS and eTMF platforms, improving the quality and efficiency of study activities from start-up to close-out.
"goBalto empowers our visibility into the traditionally cumbersome process of activating investigative sites for clinical trials," noted Carol Aliyar, Executive Vice President, Study Start-Up. "We can 'at-a-glance' track milestones and associated activities on the critical path and view the end-to-end deliverables, allowing us to navigate sites successfully through the start-up phase to the point where patients can be enrolled. Additionally, capturing robust clinical and operational data allows us to enhance our predictability model for forecasting."
"Sponsors and CROs face intense pressure to speed clinical trials while boosting operational efficiency, but complex protocols, globalization, and paper-based methods have long stymied these efforts," said Sujay Jadhav, goBalto's CEO.
"Study startup, which significantly impacts the overall timeline of clinical trial conduct, is no longer the missing piece in the eClinical toolkit. INC Research is spearheading the adoption of study startup technology in the industry, as stakeholders are anxious to shorten timelines and rein in costs, in an effort to speed sought-after therapies to patients across the globe."