Focused Services
JCRPM LLC provides focused services to guide you through the development and execution of an early-stage program strategy and life cycle management, for drugs and biologics.
1
FDA Pre-IND Meeting
The goal of clinical trial FDA meetings should be to obtain agreement from the FDA regarding your interpretation of your current data and to confirm your plans for the future.
2
IND Projects
Initial IND projects are developed through a full draft timeline early in the preparation process so that time and effort are used appropriately and efficiently throughout the program. The timeline is regularly monitored and updated towards the goal of successful submission.
3
Special FDA Designations
Special regulatory designations (US Orphan Drug Designation (ODD), Regenerative Medicine and Advanced Therapy (RMAT), etc.) are focused on speed development and position product for regulatory success as the clinical and nonclinical data accrue.
4
Project Management
JCRPM LLC provides experience-based clinical trial execution to accelerate development of your product. We help you to focus your resources more effectively while monitoring clinical study progress along the way.
Let's Work Together
JCRPM LLC is always looking for new and exciting opportunities. We look forward to hearing from you.