IND Enabling and Planning…Developing a Strategy

PROMETRIKA’s team of regulatory experts can help guide you through the IND/CTA enabling and planning stages, providing strategy development support as well as the execution of the activities required for each stage. We leverage the full strength of our cross-disciplinary expertise in regulatory, clinical development, biostatistics, clinical operations, and medical writing to provide an end-to-end strategy for success.

Our Services

  • Enabling Activities
    • Clinical Development Planning
    • First-in-Human Study Design
    • Non-clinical Program Development
  • Clinical Protocol Development
  • Finalization of Non-Clinical Reports
  • Preparation of IB
  • Preparation of IND/CTA