Otsuka Pharmaceutical Development and Commercialization (Otsuka) will use TrialAssure’s proprietary clinical trial disclosure management system – a software-as-a-service (SaaS) solution aimed at improving internal disclosure through reporting tools and built-in validation.
The solution integrates with Otsuka’s master data system and enables the company to retool core data for multiple registries, furthering its ability to meet reporting requirements for global registries, according to the company
“TrialAssure’s clinical trial registration and disclosure reporting application has a configurable workflow engine that allows clients to augment regulatory intelligence for over 30 registries, including ClinicalTrials.gov and EudraCT, with internal business processes and custom registries,” Mohamad Zahreddine, CIO of TrialAssure explained.
This allows sponsors to manage the full disclosure process, including registry assessments, validation and quality checks, review cycles, approvals, and comments from regulatory authorities, he told us.
Compliance is expected to improve as much as 60% within the first year of the partnership. Further comment on the partnership could not be provided.