INNOVADERM CRO IS NOW INDERO.
READ THE ANNOUNCEMENT
Talk to us

A Success Story: Pre-IND and IND Support for an Alopecia Areata Investigational Product

Indero

Indero

Team of Experts

Author picture

Click here for a PDF version of this case study

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.

 

Need help with your next dermatology or rheumatology study? Tell us a little about your needs.

SHARE THIS POST

Subscribe to our newsletter.

Do not miss out on valuable insights and research updates. Join our scientific community today!

This field is for validation purposes and should be left unchanged.
Talk to us

Jeff Smith

Chef de la direction

Jeff Smith, Chef de la direction d’Indero Recherches, apporte prĂšs de 30 ans d’expĂ©rience dans l’industrie pharmaceutique et CRO, s’Ă©tant distinguĂ© par son leadership exceptionnel, sa vision stratĂ©gique et son innovation. L’expertise de Jeff couvre des opĂ©rations mondiales, la gestion de la croissance, ainsi que la promotion d’une culture d’entreprise collaborative. Ses atouts en matiĂšre de crĂ©ation de valeur, de gestion des partenaires et d’opĂ©rations CRO ont toujours contribuĂ© au succĂšs dans ses fonctions prĂ©cĂ©dentes. Sous la direction de Jeff, Indero continue d’étendre ses capacitĂ©s, faisant progresser les connaissances mĂ©dicales et les nouvelles thĂ©rapies en dermatologie et en rhumatologie.

Revolutionize Your Topical Trials

Efficacy insights in days, not months.

 Indero’s Early Phase 1 model enables sponsors to initiate topical studies that detect early pharmacodynamic signals much sooner than traditional phase 1, using microdosing and transcriptomic analysis. This approach reduces preclinical requirements, shortens study duration from 8–12 weeks to ≀3 days, and lowers costs, helping teams make informed go/no-go decisions faster.
LEARN MORE >