Dermatology Focused Clinical & Observational Research

Dermatology Focused Clinical & Observational Research Learn how the specialized team at Omega CRO leverages expertise in clinical trials and real-world evidence to deliver comprehensive insights into dermatological diseases and treatments.

Dermatology Focused Clinical and Observational Research

A Specialized, Scientific Approach to Dermatological Research

Chronic and complex dermatological conditions, such as atopic dermatitis, psoriasis, hidradenitis suppurativa, and alopecia areata, have a profound impact on patients’ quality of life and often require long-term, evolving treatment strategies, including the use of advanced biologic and systemic agents. At Omega CRO, we provide end-to-end support across the development spectrum—from rigorous Phase II-IV clinical trials to robust observational studies. Our dermatology specialists possess deep therapeutic knowledge and are skilled in the unique methodologies, clinical endpoints, patient-reported outcomes (PROs), and evolving regulatory requirements necessary to generate the compelling evidence needed to bring new treatments to market and demonstrate their value in real-world practice.

The Omega CRO Advantage for Dermatology Studies

Partner with Omega CRO to navigate the specific challenges of dermatological research. We combine therapeutic expertise with advanced operational execution, including specialized dermatological imaging and centralized outcome assessments, to ensure data integrity and deliver actionable, regulatory-grade insights for both clinical trials and real-world evidence generation.

Proven Experience in Dermatology and Skin Health

Our commitment to advancing skin health is demonstrated through our involvement in key clinical trials and epidemiological studies that inform public health and clinical practice.

Key Dermatology Expertise and Experience Includes

Clinical Trial Execution (Phase II-IV): We have managed numerous interventional studies across a range of dermatological conditions, including psoriasis, atopic dermatitis, and alopecia areata. Our experience encompasses trial design, site selection and training, patient recruitment strategies for competitive indications, and meticulous endpoint adjudication.

Alopecia Areata & Androgenetic Alopecia Research: We have conducted clinical trials and observational studies focusing on new therapeutic agents and devices. Our expertise includes the use of the SALT score and standardized clinical photography to objectively measure treatment efficacy.

Atopic Dermatitis (Eczema) Clinical Studies: Our team has managed clinical trials for both topical and systemic therapies, including biologics and JAK inhibitors. We are proficient in applying EASI, IGA, and pruritus NRS scales in a standardized manner across multiple sites.

Expertise in Sensitive PROs: Our experience in managing sensitive patient-reported data in conditions like erectile dysfunction directly translates to dermatology, where we expertly capture the psychosocial impact and quality of life (e.g., DLQI) in clinical and observational settings.

Comprehensive Dermatology Capabilities: From Clinical Trials to RWE

Leveraging our broad experience, we provide comprehensive support across the research continuum:

Clinical Trial Capabilities:

Trial Design & Protocol Development: Crafting feasible and scientifically rigorous protocols for complex dermatology trials.

Site Network & Patient Recruitment: Leveraging our relationships with expert dermatology sites and implementing targeted strategies to recruit challenging patient populations.

Centralized Dermatological Imaging & Outcome Assessment: We provide robust management of standardized clinical photography, including 2D and 3D imaging, to support objective efficacy evaluation. Our processes ensure consistency, quality, and blinding for central review of endpoints like IGA and PASI.

Biomarker & Bio-sample Management: Specialized handling and logistical support for skin biopsies, blood samples, and other biomarkers critical to understanding drug mechanisms and patient stratification.

Real-World Evidence (RWE) Capabilities:

RWE for Biologic & Systemic Therapies: Post-market studies tracking long-term safety, effectiveness, and treatment patterns in real-world settings.

Treatment Pattern & Comparative Effectiveness Research (CER): Analyzing data from diverse sources to understand real-world prescribing and outcomes.

Patient-Reported Outcomes (PROs) Expertise: Integrating validated dermatology-specific PROs to capture the patient’s voice in real-world care.

Registry Management: Designing and maintaining long-term registries for safety monitoring and understanding the natural history of disease.

Integrated Data Management & Advanced Analytics

Our data management and biostatistics teams are proficient in handling the unique data types in dermatology, from complex clinical trial efficacy scores and centralized image data to real-world PROs and EHR data. Our PhD-level biostatisticians collaborate with you from the start to ensure the selection of appropriate endpoints and sophisticated analytical plans for both clinical trials (e.g., mixed models for repeated measures) and RWE studies (e.g., propensity score matching).

Adherence and Treatment Pattern Analysis in Complex Diseases

Understanding real-world prescribing habits and patient adherence is critical. Omega CRO excels in analyzing data from diverse sources (EHRs, claims, registries) to uncover patterns in treatment sequencing, switching between biologics, and persistence, providing valuable insights for market access and medical strategy.

Dermatology Precision Medicine & RWE

The field of dermatology is increasingly moving towards personalized medicine. Our experts are adept at designing studies that explore treatment responses in patient subpopulations, using data from clinical trials and RWE to identify predictors of response and contribute to tailored treatment approaches.

QUOTE

In dermatology, the objective measurement of treatment response is paramount. Our expertise in managing centralized imaging and clinical outcome assessments ensures the highest data quality for our clients' clinical trials. Combined with our deep real-world evidence capabilities, we provide a 360-degree view of a therapy's profile, from controlled trials to everyday practice.

Dermatology Experts

Our in-house dermatology therapeutic experts, including medical doctors with clinical trial and practice experience, provide strategic oversight for all our studies. They ensure that protocols are clinically relevant, site training is effective—especially for subjective scales and photography—and data interpretation is medically sound.

Embedded within every study team, our medical monitors and clinical operations specialists provide ongoing support to ensure excellence in execution.