High-quality, reliable, and compliant medical writing services, guiding you from the very beginning to the very end of your trial.
To ensure compliance and a successful conduct of your trial, we can also develop training materials for investigative site staff.
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!”
Founder & CEO
Alys Pharmaceuticals
Global Head of Project Management
Alys Pharmaceuticals
Regulatory writing bridges the gap between clinical science and the documentation standards that regulatory agencies require. Well-crafted regulatory documents reduce the likelihood of agency queries, help sponsors anticipate reviewer concerns, and keep submissions on track.
Beyond individual documents, regulatory writers bring strategic value by ensuring consistency across a submission package and aligning language with the expectations of specific agencies. For sponsors navigating complex or first-time submissions, experienced regulatory writing support can meaningfully compress timelines and reduce back and forth with authorities.
Medical writing runs continuously from study startup through closeout and beyond:
Indero’s medical writing team is embedded within a CRO that works exclusively in immune-mediated diseases, which means writers bring direct familiarity with the indications, endpoints, and regulatory considerations specific to dermatology and rheumatology. The team includes clinical scientists, dermatologists, and rheumatologists, supported by contributions from Indero’s clinical research coordinators. This gives writers practical, site-level insight that strengthens the clarity and feasibility of every document they produce.
With 75+ protocols developed in the past five years and 25+ years of medical writing experience, the team combines therapeutic depth with a proven track record.
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.
