Premium dermatology and rheumatology protocols built on a scientifically sound understanding of your therapeutic area and study objectives.
Poorly written protocols can lead to costly protocol amendments, missed milestones, decreased data quality, site disengagement, and poor enrollment rates. Indero’s clinical scientists collaborate with seasoned medical, regulatory, and operational experts to draft high-quality study protocols that meet timelines and scientific standards.
An extensive list of indication-specific clinical assessments and patient-reported outcomes (PROs).
Indero is a dual-focus CRO for dermatology and rheumatology clinical trials that offers a robust and collaborative study design and protocol writing process for successful clinical trials. Tell us about your clinical trial.
Scientific discipline. Operational efficiency. Clinical development expertise. Our study design services provide the rigorous foundation, quality data, and expertise 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 and CEO
Alys Pharmaceuticals
Global Head of Project Management
Alys Pharmaceuticals
A clinical trial protocol is the foundational document that governs how a study is designed, conducted, and evaluated. While the specific components vary by study type and phase, a well-written protocol typically includes:
For dermatology and rheumatology studies specifically, protocols should also address indication-specific clinical assessments and patient-reported outcomes (PROs) relevant to the condition being studied. Across all of these elements, clarity and scientific rigor are critical. A poorly written protocol can lead to costly amendments, site disengagement, and compromised data quality.
Protocol amendments are most often triggered by:
The most effective way to prevent amendments is to invest in a rigorous, multi-stakeholder review process before the protocol is finalized. This includes input from clinical, regulatory, biometrics, and patient recruitment teams, as well as review by KOLs and experienced site staff who can flag practical issues early.
Indero’s study design process is built around therapeutic specialization and an integrated review process. Every protocol is drafted by a clinical scientist with hands-on expertise in dermatology and/or rheumatology, depending on your study, drawing on indication-specific assessment libraries, standardized templates, and continuously updated tools aligned with the latest ICH and ethics guidelines. From there, the draft undergoes a structured internal review that ensures the protocol is evaluated for scientific soundness and operational feasibility before it ever reaches a site. Protocols are also reviewed by KOLs and experienced clinical research coordinators from Indero’s CRU, who bring a site-level perspective that helps reduce deviations and amendments. With 25+ protocols developed in the past five years, this process is both proven and refined.
Indero’s clinical scientists work closely with sponsors throughout the full protocol development process, from initial concept through final delivery. Collaboration typically includes:
Early alignment on study objectives: Ensuring the protocol reflects the sponsor’s scientific and strategic goals
Drafting by indication specialists: Clinical scientists with direct dermatology and/or rheumatology expertise lead the writing process, supported by standardized templates and checklists
Cross-functional review: Sponsors benefit from input across Indero’s biometrics, regulatory, patient recruitment, and project management teams, all of whom assess the protocol from their respective vantage points
KOL and CRU review: Findings from key opinion leaders and Indero’s clinical research unit are incorporated and shared transparently with the sponsor
Iterative revision: Revisions are made collaboratively until the final protocol meets both scientific standards and operational requirements
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.
