Keyrus Biopharma has gained flexibility in designing clinical trials and managing data collection, as well as increased scalability to support business expansion, with Oracle Clinical.
The solution provides comprehensive data validation capabilities through a library of reusable procedures based on Clinical Data Acquisition Standards Harmonization (CDash) and Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SD) standards. The data helps Keyrus Biopharma to improve the efficiency of data collection and validation, and reduce the time to database lock.
Keyrus Biopharma said that it is streamlining compliance and increasing security with Oracle Clinical’s audit trail capabilities and support for 21 CFR Part 11.
Keyrus Biopharma worked with Pharmasol, an Oracle Gold Partner, and used Pharmasol RapidLive an Oracle Accelerate solution that provides ready-to-use implementations of Oracle Health Sciences applications to accelerate the deployment cycle.
Olivier Perrot, head of data management at Keyrus Biopharma, said: As a mid-size organization, we needed a reliable, but easy-to-implement clinical data management system. With Oracle Clinical, which we implemented using Pharmasol’s RapidLive methodology, we are now equipped to deliver clinical trials with greater confidence and efficiency while streamlining compliance.
Neil de Crescenzo, senior vice president and general manager of Oracle Health Sciences, said: Rapidly growing contract research organizations, like Keyrus Biopharma, require flexible and scalable health sciences applications that help them to accelerate the clinical trial process while navigating an increasingly complex regulatory environment.
Oracle Clinical answers this call with unmatched functionality, scalability, and built-in compliance derived from Oracle’s experience with hundreds of companies that have conducted clinical trials.