By Masha Hoffey, Director, Clinical Analytics at PerkinElmer, Inc.
With the 2016 publication of ICH E6R2, organizations in the pharmaceutical space have been taking a fresh look at their Insource/Outsource strategies, in particular around analytics for clinical development. The ICH revision puts increased focus on vendor oversight and traceability in metrics-driven decision making, requiring sponsors to put more emphasis on the ways their organizations access and understand their data. Our customers are asking:
- Are my analytics a black box or do I understand how data is processed?
- Do I trust my analytics to drive regulated decisions?
- Do I have a good handle on how I am using metrics and data to protect subject safety?
With the increased adoption of powerful visual tools for Clinical analytics and the introduction of new collaboration and cloud capabilities, today there are more options than ever to handle analytics strategy. Analytics can be outsourced entirely to a CRO partner or data vendor, or they can be insourced fully to enable internal end-users with data insights. Hybrid approaches, with CROs and sponsors referencing the same views of critical data, are also an option. Which path is right for your team?
There are two perspectives from which to approach this important strategic decision.