• Monitoring of overall requirements and coordinating the disposition of drugs and supplies
  • Assisting with developing any CTM-related sections of protocols
  • Identifying and addressing CTM requirements for clinical projects/protocols
  • Evaluating and tracking analytical needs of projects
  • Liaising with sponsor and contractors/vendors concerning CTM issues/needs
  • Working with sponsor to develop, review, finalize, and approve project specific documentation (label text/proof approvals, packaging documents, preproduction batch records, etc.)
  • Managing/overseeing component design and ordering
  • Serving as a resource for sponsor and vendors/contractors
  • Facilitating the packaging and labeling, and ensuring the timely delivery, of clinical supplies
  • Reviewing and approving postproduction BR’s
  • Communicating CTM packaging and labeling status with necessary parties

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