Risk-Based Monitoring Assessment and Planning
Sometimes the hardest step is the first step. This is often the case with companies starting out on their risk-based monitoring journey. Let us use our experience to quickly assess where you are and support you in defining a tailor made, pragmatic plan to take you to risk-based monitoring success.
Our experience has shown that companies who take a holistic approach to risk-based monitoring, considering the processes, technology, stake-holders and change management aspects as one, will have a far greater chance of success in their RBM program. TRI will perform a rapid assessment of your progress and current capabilities in order to be able to define the most effective way forward for your business. Areas which will be assessed are as follows:
- How will RBM be employed and how will it impact your current planning and monitoring processes?
- What roles will be impacted by RBM and how will they change?
- What data are you going to use to assess risk, and how will you access that data?
- What technologies are you going to implement to support the processes of planning, risk assessment, risk management and on-going quality oversight?
- How are you going to train your staff in the new RBM processes and technologies?
- How are you going to manage the change with respect to sponsors, CRO partners and sites?
- What is the business case for RBM in your company, and how are you going to measure and monitor achievement of that business case?
Once the assessment of your progress to date and current capabilities has been completed, TRI will work with you to develop a tailor made plan to deliver the risk-based monitoring capability your business wants to achieve.
Our customers have found that working through an assessment and implementation planning process for risk-based monitoring with TRI is an enjoyable and informative way to increase your company’s domain knowledge in a collaborative environment. The result of this is a short term step change in capability for your business supported by the comfort that you have a well defined and bought into plan for the full implementation and deployment of risk-based monitoring for your organisation.
Contact us today to talk further about your business, and to kick start your RBM program.