York Bioanalytical Solutions is the UK's premier independent provider of bioanalytical services to the world's drug development industry. The company prides itself on providing unsurpassed levels of quality and fast delivery of reports to clients, as well as using the very latest technology to deliver their services.

Market Sector:
Contract Research for the Pharmaceutical and Allied Industries

Application:
Processing and Entry of Routine Laboratory Data

The Problem:
In the drug development industry data from pharmacokinetic and related studies are processed and recorded according to rigorous protocols to comply with regulatory legislation such as Good Laboratory Practice published by the Medicines Control Agency (MCA) and United States Food and Drug Administration (FDA). This is generally done using a combination of electronic and paper based systems. York Bioanalytical Solutions felt that a fully electronic system would lead to improvements to the routine data collection and checking process, and that this in turn would lead to significant improvements in laboratory efficiency. They found that there was no currently available software that could enable certain tasks to be performed in accordance with regulatory legislation and guidance.

In addition, in 1997 the FDA published 21 CFR Part 11, a guidance document advising companies that where information is collected electronically, it should comply with the requirements of this guidance, and therefore have complete audit trails and use electronic signatures. Companies were advised that this guidance was likely to be enforced from 2004. York Bioanalytical Solutions aim to be one of the first companies in the industry to be fully compliant with this regulation.

The Solution:
It was recognised that TransForm had the potential to be adapted for this application, although significant customisation of the basic program would be required to satisfy the regulatory requirements in this industry. York Bioanalytical Solutions' scientists worked in conjunction with Terrington Data Management to configure TransForm to their specific requirements.

The Benefits:
The resultant program enables data to be interrogated, recorded, tabulated, checked, approved and archived in accordance with the requirements of 21 CFR Part 11. In addition, the functionality within enables significant labour savings for both analysts and quality assurance professionals as calculations do not have to be performed or checked manually, as they are performed electronically using pre-validated formulae.

And The Future:
Terrington Data Management have worked closely with us to develop a system suitable for the computerisation of routine laboratory data, enabling York Bioanalytical Solutions to move towards a paperless laboratory environment. TransForm enables us to deliver improved and unsurpassed levels of efficiency. In addition, TransForm has been demonstrated to a number of clients who have been so impressed that they are looking into purchasing it for their own laboratories.

Comments By:
Leesa Clarke, Business Development Associate and Jeremy Cook, Managing Director.