Study sponsors and global health organizations can take advantage of Oracle Health Sciences Clinical One cloud platform to improve clinical trial efficiency.

Oracle Health Sciences and FHI Clinical Inc., a contract research organization (CRO) that manages complex research in resource-limited settings around the world, have joined efforts to improve clinical trial efficiency and help get therapies to market faster.

From Ebola to coronavirus, responses to outbreaks require diligent, coordinated approaches to be effective. Clinical trials must be established quickly; however, in regions without existing research capacity, study start-up through the entire study lifecycle can be challenged by a lack of regulatory guidance, infrastructure, qualified staff, established sites, and laboratory facilities.

Oracle Health Sciences Clinical One is the only cloud platform built from the ground-up to support all the core capabilities required for effective study management throughout the entire drug development lifecycle. With the ability to capture data from any source into a single, unified platform, Clinical One is redefining how technology supports clinical research to improve efficiency and help speed the delivery of breakthrough therapies.

'Based on our experience in crisis-response settings, the FHI Clinical team has developed a systematic approach to rapid study start-up that can be used across geographies and therapeutic areas,' said Ted FitzGerald, FHI Clinical president and CEO. 'Integrating the Oracle Clinical One platform into our approach allows us to bring best-in-class clinical software to markets and segments previously neglected, enabling us to meet compressed trial timelines with the highest quality data possible. As trial needs evolve and change, we are equipping our clients both large and small to be prepared for those changes with the ease and flexibility of Clinical One.'

FHI Clinical has adopted Oracle Health Sciences Clinical One for randomization, supply management, and data collection. The company also uses Oracle Argus Safety for safety case management; Oracle Clinical Trial Management System (CTMS) Cloud Service to manage the entire research portfolio, including study status and financial reporting; and Oracle ClearTrial Cloud Service to help budget, plan and bid on projects.

'With Oracle, FHI Clinical can position its clients for the future of clinical trials, which are evolving as the industry grows and adapts,' said Henry McNamara, senior vice president and general manager, Oracle Health Sciences. 'Clinical One is like no other platform on the market - truly unifying people, processes, and data in a way that's never been done before. We are honored to help FHI Clinical bring our Clinical One innovation to organizations that have traditionally had limited access to the technology needed to solve these important global healthcare priorities.'

Related news

For more information on the importance of building research capacity in an outbreak setting, please refer to the FHI Clinical Outbreak Response Guide.

For more information on how FHI Clinical has partnered with Infectious Disease Research Institute (IDRI) to provide full-service CRO capabilities for an immunotherapy clinical trial to combat COVID-19, please read this press release.

Download this e-book to review eight key lessons on how to approach outbreaks like COVID-19.

Learn more about Clinical One

Contact Info

Judi Palmer

Oracle

judi.palmer@oracle.com

+1 650 784 7901

Molly Thompson

Turnbridge Marketing for FHI Clinical

mthompson@turnbridgemarketing.com

+1 919 605 0022

About FHI Clinical

FHI Clinical is a full-service contract research organization (CRO) with the global expertise, responsive approaches and proven solutions to manage complex clinical research in resource-limited settings around the world. Our mission is to address unmet research needs and achieve maximum social impact by supporting the development of life-saving vaccines and medicines. Contact us at info@fhiclinical.com or 919.321.3321 to learn how we can put our diverse clinical and operational expertise to work for you.

About Oracle Health Sciences

As a leader in Life Sciences cloud technology, Oracle Health Sciences' Clinical One and Safety One are trusted globally by professionals in both large and emerging companies engaged in clinical research and pharmacovigilance. With over 20 years' experience, Oracle Health Sciences is committed to supporting clinical development, delivering innovation to accelerate advancements, and empowering the Life Sciences industry to improve patient outcomes. Oracle Health Sciences. For life.

About Oracle

The Oracle Cloud offers a complete suite of integrated applications for Sales, Service, Marketing, Human Resources, Finance, Supply Chain and Manufacturing, plus Highly Automated and Secure Generation 2 Infrastructure featuring the Oracle Autonomous Database. For more information about Oracle (NYSE: ORCL), please visit us at oracle.com.

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