Indero’s team, comprising clinical scientists, dermatologists, rheumatologists, and operations specialists, along with contributions from clinical research coordinators at Innovaderm, our clinical research unit (CRU), designs and writes comprehensive and innovative clinical study protocols tailored to your requirements and specifications. With expertise in all phases of clinical development and a vast medical writing experience, Indero ensures robust and high-quality documents. Our medical and scientific writing services include:
Clinical protocol development
Synopsis development
Protocol amendments
Participant information sheets
Informed consent forms
Assent forms
Clinical Study Reports (CSR)
Report on Previous Investigations (ROPI)
Clinical sections of regulatory submissions
CSR subject narratives
Lay summaries (for subjects who participate in clinical trials)
Literature summaries
Investigational Brochure
Pediatric Study Plan (PSP) and Pediatric Investigation Plan (PIP)
For a quarter-century, Indero has been the trusted CRO partner for biotech and pharmaceutical leaders across the globe, delivering precision, reliability, and innovation in dermatology and rheumatology clinical trials.
As your CRO, Indero gets to know your research goals, requirements, and specifications. Then, our team of medical writers develop the exact documentation you need—accurate, compliant, and easy to understand. We prioritize proactive communication, quick turnarounds, and continuous support to keep your trial moving forward.
To ensure compliance and a successful conduct of your trial, we can also develop training materials for investigative site staff.
Regulatory Writing Support
We provide regulatory writing support for clinical development plans, clinical trial applications (CTA), investigational new drug (IND) applications, regulatory responses, and more!
As a part of our medical writing services, we collaborate with medical, regulatory, and operational experts to draft high-quality study protocols that meet timelines and scientific standards.
As your CRO, Indero gets to know your research goals, requirements, and specifications. Then, our team of medical writers develop the exact documentation you need—accurate, compliant, and easy to understand. We prioritize proactive communication, quick turnarounds, and continuous support to keep your trial moving forward.
Scientific discipline. Operational efficiency. Clinical development expertise. Our end-to-end solution provides the rigorous foundation, quality data, and expertise that dermatology and rheumatology studies need to ensure effective execution and on-time delivery.
“Congratulations to the team for a very positive pre-IND meeting outcome! Your dedication and well-executed plans have laid a strong foundation for our program. This success is a significant trust-building milestone with the agency. Thank you for your outstanding work!”
Thibaud Portal
Founder & CEO Alys Pharmaceuticals
Andrea Epperly
Global Head of Project Management Alys Pharmaceuticals
Wherever You’re Going, We’re all in.
Need help with your next study? We want to learn more. Fill out the form on the right and one of our experts will be in touch.
Jeff Smith, Chef de la direction d’Indero Recherches, apporte près de 30 ans d’expérience dans l’industrie pharmaceutique et CRO, s’étant distingué par son leadership exceptionnel, sa vision stratégique et son innovation. L’expertise de Jeff couvre des opérations mondiales, la gestion de la croissance, ainsi que la promotion d’une culture d’entreprise collaborative. Ses atouts en matière de création de valeur, de gestion des partenaires et d’opérations CRO ont toujours contribué au succès dans ses fonctions précédentes. Sous la direction de Jeff, Indero continue d’étendre ses capacités, faisant progresser les connaissances médicales et les nouvelles thérapies 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.
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