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