Whilst the interest in Risk Based Monitoring (RBM) continues to grow, those responsible for making adoption decisions are shifting their initial interest from the enabling technology in isolation to the broader view of how technology and process change can support scalable compliance to the latest ICH-E6 requirements.
As the adoption of RBM continues to gain significant traction, decision makers should look for these 5 things from their RBM platform provider:
- Clinical Operations centric – RBM solutions need to be built to address clinical users’ requirements.
- eClinical vendor and CRO independence – Ensuring that you can work with data from the partners dictated by your project requirements.
- Flexibility – Making sure you can scale up at your own pace.
- Value for money – Enabling the most effective use of your clinical resources.
- Efficient processes – Reducing duplication and easing adoption.