TrialAssure announced it will partner with Otsuka Pharmaceutical Development and Commercialization to implement its transparency management system for all compounds in Otsuka's drug development pipeline.
TrialAssure's proprietary clinical trial disclosure management system is a single integrated system designed for transparency, to remove redundancy and speed the workflow steps, improve protocol registration compliance, and improve compliance with results disclosures. Compliance is expected to improve by as much as 60 percent in the first year. These efficiencies will be brought to all Otsuka compounds, including central nervous system and neurology, oncology, and cardiovascular and renal system therapeutic areas.
"With their corporate commitment to trial transparency, Otsuka will have the tools they need to meet their compliance obligations, manage and automate workflows, and the ability to more easily measure performance with dashboards and KPIs, including timeliness to complete trial registrations and disclosures," said Zach Weingarden, Product Solutions Manager, TrialAssure. "We are proud to be able to partner with Otsuka to ensure the quality, compliance, and completeness of clinical disclosure reporting to all necessary global regulatory agencies."
TrialAssure will provide a software-as-a-service (SaaS) solution to Otsuka, allowing their internal disclosure experts the ability to use reporting tools, built-in validation, the ability to integrate with their master data system, and the ability to retool core data for application to multiple registries, meeting global reporting requirements for ClinicalTrials.gov, EudraCT, and other global registries.
"Otsuka recognizes the value of TrialAssure's public registry tracking tool to help us manage our Clinical Trial Disclosure requirements and responsibilities, from study registration to results posting and all associated tasks," said Annadoir Staveley, Associate Director of Clinical Trial Disclosure & Transparency, Otsuka. "The developers have mitigated many key compliance issues by including audit trails and other accountability mechanisms. The flexibility in workflow makes it a tool easily implemented in just about any organization."