China-based Sichuan Kelun Pharmaceutical Research Institute (Kelun) has implemented Clinical One Randomization and Supplies Management Cloud Service from Oracle Health Sciences to fully automate and manage its new multi-site, double blind colorectal cancer study.
Using the tool, Kelun has been able to manage its trial supply and randomisation more effectively.
The tool has also enabled Kelun’s contract research organisation (CRO) partner and service providers to automate their processes by using Oracle Health Science’s Cloud-based system.
It has further provided the institute with role-based analytics to track and manage supply status of drugs in real-time.
Kelun Clinical Research Hub Biostatistics and Data Management vice-president Xiaoping Zhang said: “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.”
Clinical One Randomization and Supplies Management is designed to allow coordinators to quickly add patients to a trial, as well as collect screening information and ensure eligibility for randomisation in shorter durations.
It also eliminates the requirement of manual and repetitive data entry.
Oracle Health Sciences general manager and senior vice-president Steve Rosenberg said: “Our eClinical platform, Clinical One and randomisation 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.”
The company has developed the Oracle Cloud platform, which currently provides software as a service (SaaS) applications for enterprise resource planning (ERP) and human capital management (HCM), among others.