The Clinical and Research Excellence Awards recognize goBalto's Activate Configuration Designer in the 'Best Sponsor-Focused Technological Development' category.
goBalto has for the third year in a row been selected as an innovator in clinical trials, despite a massive 53% increase in entries received by Informa.
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. For example, ClinOps teams can 'on-the-fly' add new activities and submission activities needed to be tracked in response to a new protocol amendment, thereby minimizing the impact and associated cost on the study and ensuring country and site level compliance.
The Configuration Designer allows ClinOps teams to rapidly deploy new studies by utilizing a library of organizational or preconfigured 'out-of-the-box' country specific document workflow baseline configurations and modifying these based on regulatory, organizational, strategic partnerships or study specific requirements. This ensures activities and tasks associated with the study at the site and country levels are automatically aligned and workflows implemented to guide ClinOps teams through the process of activating sites to investigational product release and enrolling the first patient, and through into conduct. Workflows trigger alerts to notify team members of next-steps in the process and role assignment ensures coverage in the advent of staff shortages, as well as facilitating on-boarding for new team members.
goBalto Activate Configuration Designer has been shortlisted for the awards ceremony, taking place at the Boston Harbor Hotel on Wednesday, 25 April 2018.
The CARE Awards provide the industry with an opportunity to acknowledge and applaud its highest achievers across all parts of the value chain, and to recognize both corporate and individual achievement.
"The Configuration Designer is key to this workflow-based approach ensuring critical indicators of trial quality, that is compliance with regulatory and SOP requirements, can be assessed on an ongoing basis so that corrective actions can be made earlier. Intelligent document routing and subsequent process improvements that it triggers have reduced cycle times by over 30%, resulting in significant cost savings and earlier market entry.
The CARE Awards' recognition of goBalto's Activate Configuraton Designer supports our continued efforts, and that of our customers and partners, to accelerate the clinical trials process; we are honored that our technology has again been acknowledged among the best solutions in the industry."
Clinical trials that get off to a good start are more likely to be successful trials. The study startup phase is where this happens, and includes such activities as investigator selection, regulatory and ethics submissions, site trainings and ends with the site initiation visits. Study startup is a time-consuming component of a clinical study, a notorious bottleneck, that can contribute to significant delays due to manual and old-school paper-based processes, requiring multiple approvals and hand-offs between sponsor and sites, as well as, between individual team members both at the site and within/between the sponsor, which makes the process a perfect candidate for optimization.
"Today, the industry still predominantly relies on unsophisticated and inconsistent practices for study startup. Our nomination reflects goBalto's commitment to the innovation needed to better manage clinical study startup, which represents a substantial opportunity for sponsors to reduce study timelines, and costs, enabling therapies to get to those in need faster," added Jadhav.
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