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Steps and Actions Taken
Pre-IND Submission
- Clinical Section Development: Preparation of clinical sections of the pre-IND and provide clinical trial design suggestions.
- Synopsis Writisng: Drafted the synopsis for their first clinical study.
- Pre-Clinical Data Review: Conducted a quick review of toxicology and pre-clinical data to identify any potential impacts on the clinical phase.
IND Application
- Respond to the FDA’s Feedback: Provide support to reply to FDA feedback received during the pre-IND.
- Investigational Plan: Planned the clinical trials strategy to support an efficient path to drug approval.
Clinical Program Support
- Protocol Development: Collaborated on protocol writing.
Key Takeaways
| Comprehensive Support | Client-Centric Approach | Expertise in Clinical Planning |
| Provided clinical end-to-end support for pre-IND submission to ongoing IND application development. | Demonstrated flexibility and availability to accommodate the different time zones, ensuring seamless communication and collaboration. | Successfully planned and developed study synopsis, showcasing our expertise in the therapeutic area. |
Future Considerations
Ongoing Support
Continue to provide comprehensive support as this client progresses through the clinical phases.
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