How to Optimize Bioanalysis Study Data

Information technology continues to advance across our work and home lives. Social media and mobile devices are transforming communications, data acquisition, and information sharing. At work, technologies drive productivity, efficiency, quality, and innovation; recently, with Big Data, they provide insights into oceans of disparate information. But can today’s bioanalytical (BA) operations fully leverage technology to more quickly generate better-quality study data?

Huge productivity gains from more sensitive instruments, efficient sample management, and robust assays have been achieved. However, what often lacks is an effective approach to data management. Bioanalytical laboratories are no longer just about method-based execution of tests; they generate diverse data assets that must also be encapsulated. A complex, interdependent process, bioanalysis involves various teams, all contributing to moving innovations from inception to delivery. An effective informatics infrastructure must therefore be placed at the heart of the enterprise for everyone to use.

Transformative change using electronic lab notebooks

Several forward-thinking BA laboratories are blazing a trail and achieving transformative change using high-context data and process management electronic laboratory notebooks (ELNs). By managing their entire BA data work flow and driving existing LIMS, sample banks, and analytical instruments, superior-quality data are being generated. Consistency of process across diverse sites and regional compliance with multiple regulatory frameworks is also improved.

Accelerated laboratory throughput

These next-generation ELNs focus on the data, and together with work flow support, accelerate laboratory throughput. Both structured and unstructured data can be captured and organized, work flow and process management implemented, and quality assurance (QA) automatically enforced. Reviews are conducted by evaluating specific exceptions, and data are reported by simply running queries. Inefficiencies caused by data silos are eliminated, while the time taken from sample receipt to report delivery is reduced.

Increased laboratory capacity

The administrative burden on BA scientists is considerable, so relieving them of time-consuming reporting means freeing up more time for valuable research. Data-centric ELNs can collate results, and all supporting collateral, across multiple runs into a single report. Delivery time for study reports can also be dramatically improved, with final reports often available within just a couple of weeks. This level of turnaround after the last sample has been received, compared with 1–2 months using hybrid or fully paper systems, is unprecedented.

Improved data quality and traceability to support compliance

Regulatory reporting is hugely resource intensive. Every laboratory submitting BA data to a regulatory agency must comply with comparable guidelines. However, with all laboratories operating in different ways, data-centric ELNs can save vast resources by collating data across multiple runs into a single report. Validated templates provide secure links between the original data and any final calculations. Data are recorded as with traditional paper records, but with the added advantages of security and rapid validation of entries, and in compliance with pre-established business and scientific rules. Data can be captured, verified, and reviewed from the entire BA process in one systematic, compliant environment. In addition, data can be accurately reconstructed months, or even years, later.

Having such an effective informatics infrastructure promotes effective collaboration and delivers high-quality, context-rich data—the lifeblood of any BA operation. Today’s best knowledge data management environments are totally paperless and platform neutral, and enable complete and secure single-point access to data. Their ability to integrate intelligently with existing processes raises the question—Why are they not being adopted by more labs? It is an approach that truly leverages technology to generate better-quality, faster, and more efficient study data while delivering the next round of productivity gains for bioanalysis laboratories.

Joe Rajarao, Ph.D., is Client Engagement Manager at ID Business Solutions Inc., 750 U.S. Highway 202, Ste. 200, Bridgewater, NJ 08807, U.S.A.; tel.: 908-429-2900;e-mail: jrajarao@idbs.com; www.idbs.com.

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