European Contract Research Organization Gains New Agility and Facilitates Compliance with Oracle Health Sciences Applications
Redwood Shores, CA – March 29, 2010
Keyrus Biopharma, a contract research organization operating in Europe and part of the Keyrus Group, has standardized on Oracle® Clinical (www.oracle.com/us/industries/life-sciences/042878.html) and Oracle Database (www.oracle.com/us/products/database/index.htm) to help increase efficiency in clinical trial data collection, improve data quality and security, and support the organization’s European expansion plans.
With Oracle Clinical, Keyrus Biopharma has gained greater flexibility in designing clinical trials and managing data collection, as well as increased scalability to support business expansion.
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 (SDTM) standards – that help Keyrus Biopharma to improve the efficiency of data collection and validation, and reduce the time to database lock.
Keyrus Biopharma is streamlining compliance and increasing security with Oracle Clinical’s robust audit trail capabilities and support for 21 CFR Part 11.
Oracle’s strength and stability as a leading provider of IT solutions for the health sciences sector and Oracle Clinical’s broad functionality were key factors in Keyrus Biopharma’s selection process.
Keyrus Biopharma worked with Pharmasol (www.pharmasol.de/) , an Oracle Gold Partner, and used Pharmasol RapidLive (www.pharmasol.de/en/rapidlive.html) – an Oracle Accelerate solution that provides ready-to-use implementations of Oracle Health Sciences applications – to accelerate the deployment cycle.
“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,” said Olivier Perrot, Head of Data Management, Keyrus Biopharma.
“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,” said Neil de Crescenzo, Senior Vice President and General Manager, Oracle Health Sciences.
Oracle in Health Sciences (www.oracle.com/industries/health_sciences/index.html)
Oracle Clinical Data Sheet (www.oracle.com/industries/life_sciences/oracle-clinical-data-sheet.pdf)
Follow Oracle Health Sciences on Twitter (twitter.com/oraclehealthsci)
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Market Research Firm Cites Oracle as Top Software Vendor for the Life Sciences Industry (www.oracle.com/us/corporate/press/019208)
About Keyrus Biopharma
As a Contract Research Organization (CRO) and major player in clinical research, Keyrus Biopharma has been assisting the pharmaceutical industry for over 12 years in the development of their drugs. Today, Keyrus Biopharma provides expertise and consultancy in all clinical research areas on the basis of this experience and has adapted to the requirements of new environments / areas such as nutrition, biotechnology, cosmetology and medical devices. Keyrus Biopharma employs over 150 associates and is located in France and Belgium (Paris, Nantes and Brussels). More information at www.keyrusbiopharma.com (www.keyrusbiopharma.com)
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