AIT Bioscience, a bioanalytical contract research organisation (CRO) supporting preclinical trials and all phases of clinical drug development, has selected IDBS to deliver a fully electronic laboratory notebook system to record, organise and archive the bioanalytical data provided to its pharmaceutical and biotechnology clients.
AIT Bioscience has implemented a totally paperless system which addresses the challenging commercial and regulatory requirements faced by CROs; specifically to deliver quality-assured methods and regulated study results and reports to their customers at a competitive pace.
‘We adopted E-WorkBook to take advantage of the latest information technologies which could support our goal to provide bioanalytical preclinical and clinical study data at a faster pace, with higher quality and at higher efficiency,’ said Ronald Shoup, executive director of AIT Bioscience.
E-WorkBook enables the organisation to dramatically improve its delivery time for study reports, and it is now able to release its final study report one to two weeks after the last sample has been received, as opposed to between four and eight weeks using hybrid or fully paper systems. Manually validating data from a paper record or spreadsheet involves significant labour costs, using staff who are technically able to understand the complexities of the experiments and how the data contributes to the final reports.
E-WorkBook's validated templates also provide secure links between the original data and any final calculations for ease of audit. This enables AIT Bioscience to assure customers that their data is recorded just as securely as a traditional paper record, but with the added advantages of rapid validation of the data entries against pre-established business and scientific rules.
Additionally, data can be segregated by study, sponsor and regulatory level to ensure confidentiality and control. Linking with Watson LIMS, E-WorkBook also manages laboratory process control, business workflows and equipment records, alongside instrumental data.
‘With IDBS we are operating in a laboratory that is not only fully electronic, but is also more convenient for our scientists, compared to using paper records, and at the same time, we allow the required QA/QC processes to occur more quickly,’ commented Shoup. ‘We realised from the start that these advantages would only accrue from a fully electronic data package, and as a result our organisation can deliver fast turnaround times with cost savings to our customers.’
E-WorkBook Suite supports Quality by Design and audit by exception guidelines. It further enables review and verification of information in real time and guarantees that the data can be accurately reconstructed months or years later. Scientists can now capture, verify and review data from the entire bioanalytical process in one systematic, compliant environment.
