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Inderoâs support helped this alopecia areata (AA) product progress seamlessly to clinical stages.
Steps and Actions Taken
Pre-Investigational New Drug (IND) Submission
- Clinical section development: Prepared clinical sections of the pre-IND and provided clinical trial design suggestions
- Synopsis writing: Drafted the synopsis for their first clinical study
- Preclinical data review: Conducted a quick review of toxicology and preclinical data to identify any potential impacts on the clinical phase
IND Application
- Respond to the FDAâs feedback: Provided support to reply to FDA feedback received during the pre-IND.
- Investigational plan: Planned the clinical trialâs 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 |
| 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. |
Future Considerations
Ongoing Support
Continue to provide comprehensive support as this client progresses through the clinical phases.
âFrom pre-IND submission to protocol, Indero brought therapeutic-area expertise and a genuine partnership approach that made a complex early phase program feel manageable. Their proactive support kept us on track and gave us confidence heading into clinical development.â â Head of Clinical Operations, Midsize Biotech Company
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