INNOVADERM CRO IS NOW INDERO.
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A Success Story: Pre-IND and IND Support for an Alopecia Areata Investigational Product

Indero

Indero

Team of Experts

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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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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.

Is Now

We are excited to announce that Innovaderm is rebranding our CRO division as Indero (in-dAIR-oh). This rebranding reflects our ongoing commitment to innovation and our expansion into the field of rheumatology, a therapeutic area closely linked to dermatology. As a dual-focus CRO specializing in both dermatology and rheumatology, this strategic decision marks a significant milestone for our organization, and we are eager to embark on this new chapter with our valued partners and clients. Additionally, our Clinical Research Unit (CRU) will keep the name Innovaderm and will continue to conduct dermatology studies.