Clinical & Medical Consulting
Preparing to submit an application to the FDA/EMA can be overwhelming and stressful. ClinPro Trials will partner with you to make the entire process as smooth and efficient as possible. As such, we can assist with your Regulatory submissions by reviewing and/or authoring the following:
- Investigator’s Brochure (IB) submissions
- Preclinical and clinical study protocols
- Risk Management Plans (RMP)
- Protocol design & clinical trial planning
- Assist with initial indication selection, incorporating “Quick to POC” and commercial considerations into study designs
- Develop Key Opinion Leaders (KOLs) and Advisory Panel Networks
- Assist with preparation for and provide representation at meetings with regulatory agencies