Dermatology

Turn Subjective Derm Data Into Approval-Ready Evidence

We align study design with real-world care to deliver high-quality, consistent data, so your dermatology clinical research can move at the speed of science.

Go From Complexity to Consistency

Why stress about subjective endpoints, recruitment, and regulatory challenges when you can partner with Caidya? With our dermatology clinical research expertise, you’ll:

Meet Diverse Regulatory Requirements

We help you align with FDA, EMA, and Asia-Pacific authority (NMPA, PMA, CDSCO) expectations to comply with CDISC data standards and set you up for submission success.

Increase Trial Integrity

We harmonize endpoints, assessments, and intra-site scoring variability so you get reliable, credible data.

Select the Right Mix of Sites

We optimize your country and site selection to align with local requirements, prioritize diverse populations, and target key markets, maximizing your data quality and global regulatory acceptability.

Proactively Prepare for Approval

Our team helps keep data, documentation, and regulatory plans on track to reduce risk and increase your chances of success.

Your Dermatology Clinical Research Experts

Our dermatology team of operational, clinical, and medical specialists is led by Lori Lombardo, VP & Therapeutic Area Leader, Dermatology and General Medicine. With more than 28 years of experience in both pharma and CROs, Lori offers extensive experience in promoting data reliability, regulatory alignment, and patient recruitment across every clinical development phase, from early engagement through regulatory acceptance.

Lori Lombardo photo

Lori Lombardo

VP & Therapeutic Area Leader, Dermatology and General Medicine

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My team helps researchers respond to today’s evolving dermatology research landscape by providing a smarter, more successful path that enhances continuity and accountability across their program.

Lori Lombardo - VP & Therapeutic Area Leader, Dermatology and General Medicine

Generate Approval-Ready Data

We help multi-regional dermatology trials overcome common challenges, increase efficiencies, and generate interpretable, submission-ready data with:

Endpoint Consistency

We minimize variability by unifying endpoints, protocols, and methods across investigators and geographies.

Globally Aligned Assessments

We provide consistent assessments by:

  • Standardizing imaging protocols, equipment, and processes across sites
  • Training for image acquisition and interpretation
  • Employing central readers and core lab models

The Right Sites

We thoughtfully select countries and sites to meet regulatory plans and local data expectations while targeting diverse, globally relevant populations to maximize data quality and support data integrity.

Local Data

We plan for pre-specified efficacy and safety analyses in local and regional subgroups, so you’re fully prepared to prove that your therapy is effective, globally and locally.

Our Dermatology Clinical Research Services

  • Clinical trial feasibility and site identification aligned to regional needs
  • Endpoint/imaging operationalization
  • Decentralized/remote assessments
  • Regulatory strategy for global dermatology approvals through integrated clinical trial regulatory services
  • Validated partnerships for imaging, devices, and specialty services
  • Patient recruitment and retention strategies
  • Inspection-ready quality systems

How Can Caidya Help Your Dermatology
Clinical Research?

With Caidya as your partner, your dermatology trial will have harmonized endpoints, meet local data expectations, and maintain inspection-ready systems because of:

  • Specialized support with dedicated project managers, clinical trial managers, and clinical research associates with Phase I to III experience
  • The right investigators, as our established network of sites helps facilitate smoother study conduct
  • A patient-centric approach to improve participant retention and generate higher-quality long-term data
  • Validation, standardization, and data integrity to meet increasingly rigorous trial endpoints
  • Operational best practices with consistent imaging protocols across sites and centralized image review

Frequently Asked Questions
in Dermatology Clinical Research

How do you keep dermatology assessments consistent across sites and countries?

Dermatology trials must standardize endpoint definitions and scoring criteria across all regions, supported by centralized training, certification, and ongoing calibration of investigators. Caidya utilizes continuous monitoring and refresher training to help detect and correct scoring drift, promoting consistent assessments globally.

How do you manage imaging and photography endpoints in dermatology trials?

Unified imaging protocols must cover equipment, lighting, positioning, and capture procedures. We enhance standardized interpretation through centralized review or core laboratory models, combined with targeted site training to minimize acquisition and reader variability in dermatology trials.

What do you do when regulators require local data?

We plan early by identifying local data requirements and engaging with regulators upfront. This includes enrolling region-specific subpopulations, selecting appropriate sites, and pre-specifying subgroup analyses to help data meet regulatory expectations in dermatology studies without delaying timelines.

How do you design a “smart” country and site mix for global dermatology approvals?

Caidya aligns country and site selection with the global approval strategy, balancing geographic diversity with data consistency. By managing heterogeneity risk and selecting representative populations, we reduce the need for bridging studies while maintaining robust, generalizable data.

How do you plan for diversity and inclusivity in dermatology trials?

We proactively promote the inclusion of diverse dermatology and patient populations to enhance clinical relevance. Our process involves thoughtful recruitment planning, tailored site selection, and standardized assessment approaches to maintain consistency while reflecting real-world diversity.