Cell Tracking for Advanced Therapy Clinical Trials

Cell Tracking for Advanced Therapy Clinical Trials

The Cell Tracking Process

Medpace manages the many changes in custody that need to be tracked:

Ready Access and Documentation

A study-specific portal for sites, vendors, and Sponsors provides access to the status of the IP and delivers real-time status notifications. This cell tracking portal is an integrated component of ClinTrak®, our comprehensive study management technology platform.  Within this system are site-friendly forms and source documents to ensure the chain of custody and identity process is maintained and key quality metrics are captured and shared. An integrated and intuitive cell therapy manual, with chapters and flow diagrams to simplify the often complicated and lengthy process, is developed for each trial. The manual is reviewed by medical monitors and advanced clinical practitioners who have advanced training and experience in cellular therapy to ensure it is conducive with institutional standards.

Key Medpace Advantages:

  • Experienced global teams: Specialized experts in medical, operations, and regulatory evaluate each study individually to determine the best path for success
  • Streamlined operations: Simplified communication between the Sponsors, sites, Medpace, and vendors such as depots or manufacturing organizations
  • Robust training: We facilitate site training, including a dry run of the tracking system to ensure that the patient gets the right product at the right time and under the appropriate storage conditions
    • Developed mitigation strategies to prevent delays due to COVID-19
  • Automated systems: A single interface automatically notifies necessary contacts of real time updates when actions are taken
  • Regulatory considerations: We provide documentation of process that satisfies the requirements of global regulatory agencies