Informatics
months – a significant breakthrough in efficiency for preclinical scientific and quality groups.
Conclusion
Many companies are now recognising that using ELNs as purely paper-based replacements means they are missing out on strategic long term benefits, and are now integrating LIMS and legacy ELNs with those that provide data- and context-centric architectures. The growth in use of ELNs in preclin- ical environments has resulted in major advances in functionality that are allowing them to become the de facto standard for data management and corpo- rate knowledge capture. By employing these capa- bilities organisations can streamline the preclinical development, provide a foundation for QbD and reduce the burden of regulatory compliance.
Acknowledgements
Thanks to Jeff LoCascio, Chris Molloy and others at IDBS for sharing their thoughts on this area. DDW
Figure 4
ELN data in Microsoft® Word can deliver study and
regulatory documentation with robust and streamlined QA and auditing. Report generated using IDBS E-WorkBook
testing is complete, study reports and eventually reg- ulatory submissions need to be prepared. It is com- mon for the data to be distributed across multiple data sources, storing structured results and scientif- ic interpretations. A challenge for all groups is bring- ing this information together and then validating that the content of a report is accurate and no tran- scription errors have occurred. Report content can take weeks to prepare and many more weeks to val- idate because everything needs to be checked across different departments against multiple electronic and paper-based systems. Researchers want, and generally need, to write reports in Microsoft® Word, so the Enterprise ELN must allow researchers to develop report templates that can automatically populate documents used throughout development, from study reports to regulatory submissions. These validation and study reports need to be generated as far as possible automatically, using digitally signed experimental data with the reports having active hyperlinks back to the source data captured in the ELN to streamline report validation and QA. Consolidation of data to a single authori- tative source allows simpler real time checking and validation of data, resulting in fully prepared, QA and validated reports in days or weeks instead of
48
Simon Beaulah is Head of Product Marketing at IDBS. He has been working in life science and healthcare informatics for more than 20 years, ini- tially in research and over the past 12 years for a number of informatics vendors. Mr Beaulah has degrees from Aston University and Cranfield Institute of Technology.
Dr Paul Denny-Gouldson has almost 15 years’ expe- rience in pharmacology, pharmaceutical drug devel- opment and ELN software development. He joined IDBS in 2005 when the company he founded, Deffinity Solutions, was purchased by IDBS. Prior to this, he was Senior Scientist at Sanofi-Synthelabo (now Sanofi-Aventis). Dr Denny-Gouldson obtained his PhD in Computational Biology from Essex University in 1996 and has authored more than 20 scientific papers and book chapters.
Dr Scott Weiss joined IDBS in 2004, bringing more than 20 years’ experience in pharmacology, neuro- science and pharmaceutical drug development. Formerly Director of In Vivo Pharmacology at Vernalis Research, he managed a multidisciplinary department of scientists whose remit spanned from target validation, secondary and tertiary efficacy test- ing, PKPD and cardiovascular safety. Dr Weiss obtained his PhD in Experimental Psychology from Leeds University in 1995, and has authored more than 40 scientific papers and three patent applications.
Drug Discovery World Summer 2010
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