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/
About TrialAssure
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.
About Otsuka
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
Media contact
Don McLean
+1-734-245-0165
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Phase III SELECT-GCA Trial Results Lead to FDA Approval of Rinvoq for Giant Cell Arteritis
April 30th 2025Rinvoq (upadacitinib) becomes the first oral JAK inhibitor approved by the FDA for the treatment of giant cell arteritis in adults, following robust data from the Phase III SELECT-GCA trial demonstrating its efficacy in achieving sustained remission and reducing glucocorticoid exposure.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.