With an increasing number of contract research organisations available, purchasing managers or scientists are now confronted with a number of different options in terms of partnering a project with a particular CRO. Dr Andrew Penman reports.
In general there are three critical components that must be evaluated in any exercise involving the use of a contract research organisations (CRO) namely quality, timelines and cost. In the past these three criteria have been ranked in various different orders and as the CRO industry evolves we have found that the rank order of these criteria changes.
In addition, less quantifiable criteria are now routinely demanded by clients in the form of for example reactivity, flexibility and transparency.
A good example of a way in which Cephac Europe SA, with expertise in RIA, HPLC, GC-MS and
LC-MS/MS, has reacted to the demands of the market is in the development of a secure extranet system to facilitate access to bioanalytical data across the internet to those clients wishing to view data as soon as it is available.
This novel system (Aster.Cephac NET) has been developed in-house at Aster-Cephac in order to give ownership of study related data to the sponsor as soon as is practically possible.
The system is relatively simple to use (standard internet browser) utilises no add-on software, and can be up and running after assignation of a user name, a personal identification number (PIN) number and a RSA SecurID token.
All bioanalytical data at Cephac Europe is managed using a proprietary LIMS system. Aster.Cephac NET is able to access the data in the LIMS system after validation by the Study Director in our laboratory.
This is made possible by use of a copy of the LIMS database which permits clients to see data in real time from whatever location they wish.
Clearly for this type of service offering, it is vitally important that access is strictly controlled and that data is secure. Laurent Fournier, IT Director, said: "We are using the very latest tools to protect the security of client data.
"Security measures include: data encryption, dynamic passwords, server certificate and a sophisticated access privileges management system.
"Detailed audits both by clients and an independent company have shown that the system is really secure.“
Currently customers can review online data including tables of analyte concentrations, concentration/time graphs, QC data, calibration data and status of analytical runs.
Exciting developments planned for the future include the ability to work securely on shared documents (protocols, reports etc) and the ability to track samples.
Cephac Europe believes that this type of approach will soon be commonplace within the industry and are poised to take advantage of the challenges that this opportunity presents.
The Aster.Cephac Group is a leading European contract research organisation (CRO) providing clinical and bioanalytical services to companies developing pharmaceutical, cosmetic and OTC health care products. It concnetyrates on value added early drug development: Phase I - II, Proof of Concept, PK/PD and Bioanalysis studies. The group offers its services on an international scale to clients in mainland Europe, Scandinavia, the UK, the US and Japan. u
ENQUIRY No 19
Dr Andrew Penman is president and ceo of Cephac Europe SA, Saint-Benoit, France. www.aster-cephac.com
