Data and Process Management for New Solutions: 3 Models to Consider

When preparing to implement a new solution, there are two fundamental decisions you must make about the solution model. First is whether to host the application locally or externally (e.g., SaaS), but that’s a discussion for another article.

The second, equally important thing to consider is who will manage the process and data. Since many life sciences processes lend themselves to outsourcing, considering your current and future intentions in this area can impact the solution you choose. Essentially, you have three options:

1) Fully Internal: Sponsor Owned and Managed

If we are talking about a core business process (where the management and oversight of the data and process are critical), this is the best option. In this case, the sponsor implements the software and uses the software for their business process – there is no outside party involved.

2) Hybrid: Sponsor Owned, CRO/Vendor Managed

With this option, the sponsor implements the software, but they contract the business process to a CRO/Vendor. This model ensures the sponsor has complete access to and oversight of the data without the resource burden of performing the process. A great example would be a sponsor-implemented electronic data capture (EDC) system where a CRO handles the data management function.

3) Fully Outsourced: CRO/Vendor Owned and Managed

For situations where resources are scarce and quick data access is not as critical, the best option might be to outsource both software implementation and business process management to a CRO/Vendor. This is a good solution for smaller, growing life sciences companies who are short on staff or expertise and need to completely outsource a function (such as pharmacovigilance or data management).

Thinking about where your application will be hosted is important, but don’t forget to also think about how your process and data need to be managed. The best solution will come from balancing the capabilities of your available resources with your requirements for data access and process oversight.