IDBS and AIT Bioscience Deliver First Paperless Bioanalysis Lab
IDBS announced that AIT Bioscience, LLC, a bioanalytical contract research organization (CRO) supporting preclinical trials and all phases of clinical drug development, has selected IDBS to deliver a fully electronic laboratory notebook system to record, organize, 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.
Neil Kipling, founder and CEO of IDBS commented, “Working closely with AIT Bioscience, we have deployed an industry-leading informatics infrastructure that provides them with competitive advantage, regulatory compliance and efficiency.”
Dramatic Improvements in Reporting Time
E-WorkBook enables AIT Bioscience to dramatically improve their delivery time for study reports. They are now able to release their final study report 1-2 weeks after the last sample has been received, as opposed to between 4-8 weeks using hybrid or fully paper systems. Manually validating data from a paper record or spreadsheet involves significant labor costs, using staff who are technically able to understand the complexities of the experiments and how the data contributes to the final reports.
Quality and Security Assurance
E-WorkBook’s validated templates provide secure links between the original data and any final calculations for ease of audit. This enables AIT Bioscience to assure its 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. E-WorkBook enables AIT Bioscience to segregate data by study, sponsor and regulatory level to ensure complete confidentiality and control.
Enabling the Electronic Laboratory
E-WorkBook links seamlessly with Watson LIMS and comprehensively manages laboratory process control, business workflows and equipment records, alongside instrumental data.
Shoup continued, “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. We realized from the start that these advantages would only accrue from a fully electronic data package, and as a result our organization can deliver fast turnaround times with cost savings to our customers.”
Meeting Regulatory Requirements
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. AIT Bioscience scientists can now capture, verify and review data from the entire bioanalytical process in one systematic, compliant environment.
Neil Kipling continued, “AIT Bioscience has demonstrated a forward-looking and innovative approach to the regulated CRO market, being paper-free from the outset. Based on our broad domain understanding, IDBS recognizes that CROs adopting strong internal informatics solutions have greater internal effectiveness and improved customer satisfaction.”
EventAAPS (American Association of Pharmaceutical Scientists) Annual Meeting and Exhibition will be held November 14-18, 2010, at the Morial Convention Center, New Orleans, Louisiana. IDBS will be exhibiting during the conference at booth 1457 and AIT Bioscience will be exhibiting at booth 1443. For more information visit http://www.pswc2010.org/
