Regulators Are Urging Companies to Change Clinical Monitoring Operations for Sponsors and CROs Alike. Do You Know Where to Start?
- Do you want to improve sponsor oversight of site monitoring?
- Are you unsure of how your CRO is managing sites?
- Are you worried about not being FDA, EMA or ICH E6 R2 compliant?
- Do you want to implement sponsor oversight technologies of site monitoring?
Organizations Are Challenged to Reduce Monitoring Efforts and Costs. We Can Help.
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 Your Clinical Monitoring Process Changes. 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 clinical monitoring processes and how we can help to improve it. 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 Site Monitoring
With over 15 years of clinical development experience, we understand your concerns about clinical monitoring challenges and meeting regulatory requirements. Our consultants will lead projects to:
- Implement a fit-for-purpose clinical monitoring process
- Support SOP changes incorporating changes to sponsor oversight, CRO partnerships for site monitoring, and more
- Create custom clinical monitoring templates and collateral (e.g. clinical analytics management, co-monitoring process)
- Establish metrics to measure critical success factors for process changes, such as monitoring cost savings and audit findings
What Makes Our Monitoring Change Management 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 clinical monitoring change management projects done right while allowing them to focus on what they do best.
What Our Clients Are Saying…
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Stop Worrying. Become Compliant.
Be Technology Enabled.
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.