Do You Need Help with Implementation per the TransCelerate Methodology and Regulatory Guidances?
- Are you struggling with the adoption of Risk Based Monitoring?
- Do you want to build a sponsor oversight process for site monitoring?
- Are you interested in building a centralized monitoring or adaptive monitoring process?
- Do you want to implement analytics tools that support Risk Based Monitoring?
There Is a Lot of Wasted Effort If Your RBM Execution Fails. Here Are Some of the Benefits You Will Get:
Breakdown Barriers Across Orgs
Our project leads are skilled at getting your drug development functions on board. They work to eliminate duplicate processes against site monitoring and redundant analytics tools.
Get Project Managers Who Actually Lead
Some companies have “project managers” who simply schedule meetings and take meeting minutes. That is not who we are. Our Project Managers actually lead our clients.
Follow Best Practice PM Methodologies
Our certified professionals bring a proven, structured approach to successfully deliver your project. We address risk management, issue management, as well as write charters, project plans, and communication plans, etc. for your project.
Get Ready for Risk Based Monitoring. Here Is the Plan:
1. Schedule a Call
Schedule a brief introductory call with one of our experts. Pick a date and time that works best for you.
2. Have a Meeting
Tell us about your RBM project and how we can help you be successful. What are your biggest struggles and what does success mean to you?
3. Get a Customized Proposal
Based on your needs we will provide a tailored approach. We will match you with the person or team that best fits your project.
Our Consultants Know Risk Based Monitoring
With over 15 years of clinical development experience and 3 years of dedicated support with all facets of RBM, we understand your concerns about implementation challenges and meeting regulatory requirements. Our consultants will lead projects to:
- Implement a customized RBM process or follow the TransCelerate recommendation
- Support SOP changes incorporating risk assessment, key risk indicator tools, CRO oversight, and more
- Create custom RBM templates and collateral for on-site monitoring changes, off-site monitoring, and/or central monitoring
- Establish metrics to measure critical success factors, such as monitoring visit intervals improvements with adaptive monitoring
What Makes Our Risk Based Monitoring Support Different?
It is difficult to implement or improve your operations and processes and stay on top of your regular work. Most organizations struggle to execute or complete complex projects. At Praxis Life Sciences, our professionals have the industry business acumen and partner with company leaders to get their RBM projects done right while allowing them to focus on what they do best. We have project management consultants that are subject matter experts in risk based monitoring.
What Our Clients Are Saying…
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Improve Quality. Get Ahead of Regulations and Become an RBM Leader.
You shouldn’t have to worry about delaying your FDA filing because your current monitoring processes cause you to find out problems late in the game. You can become compliant and deploy effective sponsor oversight of site monitoring operations.