Last month I spoke about the ‘model’ for integrating clinical operations. In this blog post we’ll review the solution that was presented at the Oracle “OpenWorld” conference held earlier this month. There is also two links to collateral that you can use to help understand how the solution works at the end of this blog post. I welcome your reaction and comments.
I’ve written about ways to improve R&D from the idea of “ERP for R&D” through “Integration” of key business processes. In summary the background issues that I think drive this solution are:
- Access to relevant data
- Getting out of the IT business within R&D
- A solution that is scalable to meet tomorrow’s business needs
How does this solution solve these issues?
Starting with ‘Access to relevant data’ – there have been many attempts to create an IT landscape for R&D. This best-of-breed approach favors decisions that support the best solutions to meet a specific need. Yet if you take a step back and ask how I can get access to facts to make ‘key’ decisions this approach falters. The solution approach being offered starts with the premise that the user needs access to key data. Based on an individual’s role you get access to key data and permission to upload new data. This removes the user from having to make the required ‘conversions’ between solutions to create the information needed. The benefits include:
- Adaptive trials can now be easily facilitated
- Financial decisions tied to key outcomes of clinical trials can be reviewed and decided upon
- Users get to focus on the science of creating new medications and treatments and not the nuances of the technology
Getting out of the IT business – the biggest advantage to this solution is that Pharmaceutical companies can focus on their core business goals of producing new products to complex diseases.
You now have a scalable approach to R&D. This solution not only accommodates your scientists and statisticians you can also invite clinical research organization (CROs). Data security is also key to this solution since you may be adding other teams to help in the development of new clinical products. The solution also takes globalization into consideration as a result of today’s clinical trials.