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Canton, Mich. (August 21, 2018) – TrialAssure – a leading, global company focused on developing clinical trial transparency tools – announced today that it will partner with Otsuka Pharmaceutical Development and Commercialization, Inc. (Otsuka) to implement its comprehensive 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 from the ground up 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 proven 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.”
To learn how to improve disclosure accuracy, identify hidden bottlenecks, and manage transparency workload, request a demo of TrialAssure here: http://www.trialassure.com/
TrialAssure is a global clinical trial disclosure and transparency reporting suite with unmatched experience in helping clients navigate complex regulatory submission and reporting challenges. TrialAssure helps meet regulatory compliance goals through a flexible, scalable, and streamlined platform that regularly adapts to ever-changing clinical trial disclosure requirements. TrialAssure was built from the ground up as a single, integrated transparency system, and it is continually strengthened by the experience of leading pharmaceutical industry compliance experts. For more information, visit: www.trialassure.com.
Otsuka is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka Pharmaceutical Development & Commercialization, Inc. is an indirect subsidiary of Otsuka Pharmaceutical Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately US $11 billion in 2016.
All Otsuka stories start by taking the road less traveled. Learn more at https://www.otsuka.co.jp/en