Choosing the best technology to suit your RBM strategy can be a challenge.
Do I try to develop my own?
Do I try to re-purpose something I already have?
Do I implement purpose built RBM technology?
Those are just a few of questions you are likely to be asking yourself, not to mention the challenge of implementation and deployment once you've made your decision. Don't worry, TRI are here to help. We have a comprehensive understanding of the RBM technology landscape and can advise you on the best approach for your business, as well as support you through the implementation planning and execution.
How do we evaluate RBM technology?
The first question we ask is whether or not your business intends to follow some or all of the TransCelerate methodology. If the answer to this is ‘yes’ then we have a pre-defined assessment tool based on the TransCelerate functional requirements which will allow us to very quickly determine which aspect of the methodology you want to follow and therefore what the core requirements of your system should be.
If the answer is ‘no’, then we take a more process driven approach, and start by understanding the operational approach you intend to take to risk-based monitoring, the processes you will want it to support and then ultimately to define the requirements for your RBM system.
We are then in a position to evaluate the question of buy vs. build and assess the options available and guide you through the selection and implementation processes.
But TRI have their own technology, how do we stay independent?
TRI are committed to our vision of making risk-based monitoring a reality for all companies wanting to take that approach to their clinical trials. Whilst we know our OPRA platform to be a world-class platform and are confident in its ability to provide all that is needed for RBM, we also understand that some companies have long standing relationships with other vendors, or may want to develop their own in-house capability.
Whatever path you choose, TRI have the skills and experience to ensure the success of your development or implementation project.
Additional information on Phase 5: