By Chris Strassel
April 9, 2013 | Contributed Commentary | Today’s pharmaceutical industry embraces the electronic laboratory notebook (ELN) as a staple within its labs. Deployments have helped reduce paper, generate efficiencies, provide greater visibility to data, drive standardization and increase collaboration. Within major pharmaceutical companies, the ELN has been a tremendous tool for driving productivity and accelerating the discoveries that speed new and improved drugs to market. Our next focus, as ELN vendors, must be to improve the integration of electronic data capture and sharing with our pharmaceutical customers’ external client systems.
Pharmaceutical companies need their CRO partners working with the same tools, at the same speed, with the same capabilities. The current model typically involves the pharmaceutical company managing the deployment of its ELN solution at its CRO. But a host of challenges emerge when installing software on computers outside the pharmaceutical company’s firewall and control. The goal is a more seamless and smooth, yet secure, integration between the pharmaceutical company and its CRO partners—an easier external deployment of the ELN.
For pharmaceutical companies to leverage their ELNs with CROs, the software is often deployed using virtualized environments which can be expensive and complex. The range of relationships between pharma and CROs also creates challenges. For stable, long-term relationships, home-grown or workaround solutions to integrate with an external partner’s infrastructure have been developed over time and may work well enough. There is room, however, for significant improvement for more effective, secure integration. And for shorter-term or project-based relationships, or those with smaller or emerging CROs, where email and web solutions like file transfer protocol (FTP) sites often serve as modes of data exchange, a better integrated ELN can vastly improve productivity, collaboration, and visibility. A comprehensive solution would also enable communication and workflow management, where technical solutions are behind pace with the needs of virtual teams. Because CROs working with multiple pharmaceutical partners may be using multiple solutions, software training can be a real drain on the scientist’s time at the bench. Streamlined e-notebook solutions are critical toward reducing the software learning curve.
Once these challenges are resolved, any pharmaceutical company not yet using ELNs or not yet extending their ELNs to their CROs may be more likely to adopt the practice and gain the many benefits of integrated electronic data sharing. Smoother integration will also free pharmaceutical companies to leverage specialized CROs outside their preferred vendor lists, deploying the ELN to new partners and scientists quickly and securely.
The Next Phase of External Integration
Among the opportunities to increase external integration, streamlining the day-to-day e-notebook functionality for CRO users is key. Although they share information, pharmaceutical and CRO scientists follow different workflows and the ELN should reflect those differences. An interface optimized specifically for certain tasks, such as compound synthesis at the CRO, could greatly increase efficiency.
Encouraging real-time data entry into the ELN, compared to transcription from paper notes at a later time, eliminates a potential source of errors, and helps increase the sponsor scientist’s visibility of the data. Another area of opportunity is increasing the inclusion of supplemental data within the ELN, such as the supporting analytical data when transferring chemical synthesis information.
To improve communication and workflow between partners, ELNs must provide a way for the sponsor scientist to request work to be performed by CRO scientists. Rather than working through email, sponsors can, for example, generate in the ELN the lists of compound structures needed and suggest synthesis routes to create them. As work at the CRO progresses, the ELN must facilitate sponsor/CRO communication. If, for example, the sponsor scientist notices a particular reaction is attempted more than once with low yield, she can send a comment via the ELN to the CRO chemist to alter a particular reaction condition that improves the yield. Problems surface and are addressed more quickly, even before the lab work is complete.
Leveraging Data through Analytics
Over time, as relationships with pharmaceutical companies and their CRO partners grow, valuable information is accrued. ELNs interfaced with analysis and visualization software, delivering dashboard views of user-defined indicators, will provide metrics and insights that can help chart new directions, avoid errors and identify problems or opportunities. Pharmaceutical companies that leverage the vast data accumulated by their ELNs, including from their CRO partners, can identify trends and success rates, better calculate costs and make more informed decisions. Searches are then possible to determine which CRO is best for a particular kind of chemistry, which is more efficient. Sponsor scientists can query for numbers of compounds synthesized over time, average yield, or average time to complete a request.
With better integrated ELNs at CROs, the data captured externally will be more in-line with the pharmaceutical sponsor’s requirements. There will be greater real-time visibility into the quality of work as well as its progress. To date, pharmaceutical companies have created workarounds to make the most of extending their ELN solutions to their CRO partners. ELN vendors who step up with more comprehensive integration capabilities, particularly that reduce cost, complexity and IT burden, will meet a critical need of their pharmaceutical customers.
Chris Strassel is Informatics Product Manager at PerkinElmer.