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CHENGDU, China, May 14, 2018 /PRNewswire/ -- Oracle Health Sciences today announced that Sichuan Kelun Pharmaceutical Research Institute Co., Ltd ("Kelun") has implemented Oracle Health Sciences Clinical One Randomization and Supplies Management Cloud Service to fully automate the set up and management of its multi-site, double blind colorectal cancer study.
The China Food and Drug Administration (CFDA) has been driving reforms to improve the quality of drugs and to encourage innovation in the development of new drugs and medical devices. Kelun Pharmaceutical has been successfully conducting generics drug research since 1996 but recently launched its first, new oncology drug study. As with any new clinical trial, there is tremendous time and resources required to set up a new study including trial design and validation which can take weeks to months. ORS enables coordinators to quickly add patients to a trial, collect screening information and ensure eligibility for randomization in record time. In an effort to set up their own trial and eliminate manual, repetitive data entry, Kelun implemented Clinical One Randomization and Supplies Management Cloud Service.
"We needed an established, standards-based cloud system to simplify the drug supply management process, and we have already determined we made a great choice by selecting Oracle's Clinical One Randomization and Supplies Management. Within 29 days, we were fully implemented and are now in phase III of our oncology trial," said Xiaoping Zhang, VP of Biostatistics and Data Management, Clinical Research Hub.
With Clinical One Randomization and Supplies Management, Kelun has been able to manage its trial supply and randomization more effectively and efficiently and has enabled its CRO partner and service providers, including its supply shipping specialist vendor, to automate their processes by leveraging Oracle Health Science's cloud-based system. In addition to simplifying the drug supply management process, ORS has provided Kelun with role-based analytics to track and manage supply status in real time.
"Our eClinical platform, Clinical One and randomization and supplies management capability was designed for pharmaceutical and biopharma companies of all sizes, across all treatment areas and for all phases of research and development. We are excited to see Kelun leveraging technology to speed the setup and management of their trial and are hopeful that this oncology therapy will make it to market," said Steve Rosenberg, general manager and senior vice president, Oracle Health Sciences.
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