IDBS worked closely with BioIVT to develop, validate and implement the system to suit their most critical processes and needs.
The challenge
As a leading provider of in vitro ADME research services, BioIVT was looking for technological solutions to improve efficiency and build on its reputation for best-in-class responsiveness to its biopharmaceutical clients. It was critical that the solution had data processing and reporting tool capabilities to reduce data and report delivery time, which in turn could reduce study cycle times, increase capacity and provide a significant return on investment. Also, it was essential that it was flexible, user-friendly and easy to configure to promote user adoption and increase capacity since multiple departments would be utilizing the system. The major teams impacted included lab services, analytical services, data management, study directors, logistics management and maintenance & metrology. Individuals in these roles were responsible for several workflow-critical tasks, including 1) performing and documenting experimental work, 2) sample analysis and tracking, 3) data import, analysis, QC and reporting, and 4) managing equipment and chemical inventory. Because each role played a large part in delivering accurate and quality data to its clients, BioIVT needed a solution that allowed for process improvement across all teams to accelerate experimental time and data delivery. Since the Kansas City site is a GLP-compliant facility and would be the first to implement this solution, they also needed a vendor that could offer a validated solution that was 21 CFR Part 11 compliant.
The solution
BioIVT mapped out critical processes, evaluated the capabilities of various laboratory informatics solutions, and found the IDBS E-WorkBook most suitable for their needs. IDBS worked closely with BioIVT to develop, validate and implement the system. Users across various departments collaborated with IDBS to develop and validate custom workflows to streamline multiple processes.
Collaboration with each department helped promote user adoption and now each department is utilizing E-WorkBook for various workflows. The lab services team utilizes custom templates to design, execute and document experimental processes, document material and equipment use, register samples and create sequence lists for sample analysis. The analytical services team imports sequence lists into the LC-MS/MS instruments, executes and documents sample analysis, and exports raw data. The data management team imports the raw sample data back into E-WorkBook and processes the data. Finally, the study director team performs a final review and approval of the processed data and generates a data summary report that is delivered to the client. After all the experiments are complete, the data summary reports are utilized to generate a semi-automated report in E-WorkBook as the final study deliverable. With this implementation, BioIVT has moved to electronic documentation in the labs, streamlined and standardized processes and increased efficiency.
Additionally, the logistics management, lab services and maintenance & metrology teams register chemicals, test articles and equipment into E-WorkBook for inventory management and tracking using native functionality for barcode labeling. Multiple teams document chemical, reagent and equipment use and solutions preparation within the laboratories. Finally, the maintenance & metrology team documents equipment maintenance and calibration, all within E-WorkBook.
The outcome
With the implementation and adoption of the E-WorkBook, BioIVT has experienced process improvements across multiple departments. Not only does each individual user save time but as each department hands off data to the next, sample processing and data reporting are now more efficient and seamless. Based on an evaluation of 29 activities, significant efficiency gains (i.e., from 40 to 70%) were noted for the following activities.*
- Preparing, printing and correcting documentation
- Material and equipment documentation
- Processing, transferring, collating and formatting data
- QC and review of documentation and results
- Addressing QAU audit findings
The most notable team impact was for the study director and maintenance & metrology teams, resulting in an overall reduction in time across all activities by at least 30%. The combined time savings across all departments resulted in more than a 20% increase in capacity, equivalent to a weekly time savings of ~8 hours per user.*
The introduction of E-WorkBook has allowed BioIVT to realize the goals it set out to achieve. Streamlining processes has resulted in a reduction of overall study cycle times by at least 30%, allowing them to deliver data to their clients at least four weeks faster than prior to E-WorkBook implementation.*
The IDBS difference
IDBS helps BioPharma organizations unlock the potential of AI/ML to improve the lives of patients. As a trusted long-term partner to 80% of the top 20 global BioPharma companies1, IDBS delivers powerful cloud software and services specifically designed to meet the evolving needs of the BioPharma sector.
IDBS, a Danaher company, leverages 35 years of scientific informatics expertise to help organizations design, execute and orchestrate processes, manage, contextualize and structure data and gain valuable insights throughout the product lifecycle, from R&D through manufacturing. Known for its signature IDBS E-WorkBook software, IDBS has extended its flexible, scalable solutions to the IDBS Polar and PIMS cloud platforms to help scientists make smarter decisions with assured confidence in both GxP and non-GxP environments.
1. Rank measured by Market Cap, Q1 2024.
*Data on file at IDBS, accurate as of January 2025.
**IDBS Polar delivers the same or higher gains as IDBS E-WorkBook in a like-for-like implementation, with added value from advanced analytics, AI/ML and reporting.
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