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Unified clinical trial software

Unified clinical trial software for dermatology trials

oomnia unifies clinical operations for dermatology trials by supporting the evaluation of new and innovative dermatology treatment options and strengthening collaboration between investigators, pharmaceutical partners, and patients

ISO 27001 SOC 2 FDA 21 CFR Part 11 GDPR & HIPAA

INDUSTRY CONTEXT

Why dermatology trials are hard to run

Dermatology trials are challenging to run because skin‑related conditions vary widely, rely heavily on subjective assessments, and often require specialized imaging, high‑touch patient engagement, and carefully timed recruitment windows

Key challenges include:

Recruitment limitations due to narrow eligibility criteria and competing studies

High patient‑burden and retention issues

Specialized assessments such as imaging, biomarker sampling, and lesion scoring

Seasonal patterns and disease fluctuation

Enrollment barriers linked to low public awareness, limited access, and mistrust

UNIFIED PLATFORM

Why unified clinical trial software matters for dermatology studies

Dermatology trials rely heavily on images, lesion measurements, clinician assessments, patient‑reported outcomes, and longitudinal skin‑change tracking. These data streams are often fragmented across separate systems.

A unified clinical trial platform, built as a Clinical Research Information System (CRIS), brings all dermatology‑specific data into one environment, standardizing image capture, synchronizing assessments, and streamlining endpoint tracking. This improves workflow efficiency, data integrity, and visibility across dermatology trials.

Why unified clinical trial software matters for dermatology studies
Area Modular eClinical system Unified clinical trial software
Data types Images, lesion measurements, investigator assessments, and ePRO data captured in separate tools All dermatology data, images, scores, measurements, and PROs, captured and stored in one environment
Consistency & scoring Variability in image quality, lighting, and scoring across sites; inconsistent lesion documentation Standardized imaging workflows and scoring criteria applied consistently across all visits and locations
Image–assessment alignment Images stored in one system while clinical assessments live in another, requiring cross‑referencing Automatic linkage between images, visit data, and investigator assessments within a shared record
Patient monitoring Delayed visibility into lesion progression; manual comparison of photos and scores Continuous, real‑time tracking of skin‑related endpoints with side‑by‑side historical imaging
Study workflow execution Multiple logins, incompatible tools, and redundant data entry across imaging, eCOA/ePRO, and CRFs Streamlined workflows connecting sites, CRAs, and central reviewers in one platform
Data quality Higher risk of inconsistent imaging, missing assessments, and incomplete documentation Structured dermatology‑specific data capture with built‑in quality checks and required fields

CRIS ARCHITECTURE

One unified clinical trial platform for dermatology trials

oomnia brings all core dermatology trial operations into one unified clinical research information system (CRIS), helping teams manage complex, multi-endpoint studies with greater speed and consistency

Built for dermatology's multi-endpoint data needs, with a strong focus on complex scoring instruments and photodocumentation workflows

Single data model keeps clinical, operational, and PRO data aligned, reducing cross-site variability and creating a stable structure for high-volume skin disease data streams

Protocol updates handled through configuration, enabling adjustments without system rebuilds

Replaces fragmented tools with one connected workflow, cutting handoffs and minimizing reconciliation

ECOSYSTEM INTEGRATION

How oomnia fits in the dermatology sponsor ecosystem

oomnia serves as the central clinical data hub connecting all stakeholders across dermatology trial programs, ensuring consistent data flow and smooth coordination throughout the study

It integrates:

Imaging systems for lesion photography and digital skin assessments
Dermatopathology and biomarker laboratories
ePRO/eCOA tools for symptom and quality-of-life tracking
Safety and pharmacovigilance systems monitoring dermatologic adverse events
Sponsor analytics environments for real-time insights, adherence, and efficacy insights

KEY CAPABILITIES

Key capabilities for dermatology trials

Flexible study design for variable skin conditions

  • Handles complex dermatology protocols that rely on frequent assessments, lesion scoring, imaging, and flare‑dependent visit schedules
  • Easily adapts when inclusion criteria shift, assessment timing changes, or new cohorts are added
  • Keeps studies stable during mid‑trial updates, even when disease variability requires rapid protocol adjustments

Consistent clinical and imaging data

  • Captures clinical observations, imaging results, and symptom‑based ePRO data in real time
  • Unifies all core tools, EDC, CTMS, RTSM, ePRO/eCOA, eTMF, eSource, and eConsent, into a single dermatology‑focused workflow
  • Reduces manual reconciliation caused by scattered systems, supporting cleaner, more consistent dermatology data

Patient engagement and retention

  • Provides flexible ePRO/eCOA tools for itch severity, pain, flare frequency, Quality of Life (QoL) impact, and treatment adherence
  • Supports both remote and in‑clinic reporting, making it easier for patients to stay engaged despite burdensome visit schedules
  • Uses automated reminders to reduce missed assessments, critical in studies with high dropout risk

Real-time study progress monitoring

  • Offers real‑time dashboards combining clinical data, skin‑imaging outputs, laboratory results, and patient‑reported symptoms
  • Supports interim reviews, safety checks, and evidence‑based decisions across geographically dispersed dermatology studies
  • Generates export‑ready files that simplify submission packages for global dermatology regulatory pathways

Imaging and dermatopathology data together

  • Integrates high‑resolution lesion photography, digital image grading, and central imaging reads directly into the unified platform
  • Connects dermatopathology and biomarker data with safety and efficacy monitoring
  • Provides a consolidated view of clinical outcomes, imaging trends, disease‑activity changes, and objective/subjective endpoints

Purpose‑built to support the unique demands of dermatology research

Operates on one unified clinical architecture instead of stitched‑together systems

Adapts quickly when protocols change

Reduces operational friction for sites, sponsors, and CROs

Eliminates the need to manage multiple disconnected dermatology tools

VALUE PROPOSITION

Why sponsors choose oomnia for dermatology trials

Client Testimonials

Collaboration built on trust and innovation

Centinel Spine logo
Wemedoo's technology, expertise, and intimate engagement with our team in the development of the EDC, site/patient interface, and metric capabilities are unique. They provided insight and challenged the underlying assumptions to ensure the study's goals and objectives were clearly defined and the operating structure matched with the study's intent. Their system is not a one-size-fits-all and they adapt to the needs of the sponsor, sites, physicians, and the study requirements into a system that merges health information/data and can then become not only informative but actionable.

James Kuras

Vice President of Clinical Affairs and Operations at Centinel Spine

Oxular logo
Wemedoo's cross-functional, integrated teams capture EDC set-up, go-live, data capture, data cleaning, and finally data analysis in a globally compliant fashion supporting trials in different geographies including the US. Their speed of addressing customer needs sets in my personal experience industry benchmark whilst keeping these data solutions lean and affordable. Besides the great proprietary systems they use, their integrated team approach with personal responsibility and honest commitment to targeting outcomes differentiates the Wemedoo team from other providers. Wemedoo only made Oxular's key initial trial, a device-drug trial possible, as based on some pre-work, the Wemedoo team could substantially adapt and update the first EDC ideas for a trial under a US FDA IND. The Wemedoo team worked extremely focused on familiarizing US trial sites and clinical CROs with the use of their system, which turned out to be a key success factor of the respective trial. The highly professional and up-to-date capabilities in data sciences were mirrored by customer-centricity and super fast timelines of integrating mandatory adaptations to the data systems.

Friedrich Asmus

Former Chief Medical Officer at OXULAR

Appletree CI Group AG logo
All jobs, both large and small, are performed with the same dedication to quality, detail, innovative thinking, and rigor. It is always a pleasure to work with the Wemedoo team.

Georg Mathis, PhD

CEO at Appletree CI Group AG

Marti Farm Ltd logo
Wemedoo embodies all the traits desired in a partner in the clinical trial industry – expertise, innovation, reliability, compliance, and attention to detail.

Martina Diminic Smetisko, DMD

Managing Director at Marti Farm Ltd

Polpharma SA logo
Their dedication to, and support of, our projects has resulted in clear quality deliverables. They are always there to answer any questions with expertise in a timely manner. I am looking forward to our next project together.

Volodymyr Stus, MD

Biopharmaceutics and Clinical Research Department Manager at Polpharma SA

Velocious Clinical Research logo
Complex adaptive trials demand speed, precision, and system stability. With oomnia, Wemedoo's unified clinical trial software maintained continuous drug supply oversight, real-time data capture above 99%, and zero Randomization and Trial Supply Management (RTSM) dispensing errors throughout the study. The study reached database lock within 3 days after Last Patient Last Visit (LPLV), a direct result of integrated EDC–RTSM execution and proactive technical support. Wemedoo's technology and team responsiveness played a key role in meeting aggressive milestones.

Dhiraj Patel, Dr.

Director at Velocious Clinical Research

REGULATORY READINESS

Regulatory and data ecosystem readiness

oomnia delivers a structured, compliance‑ready environment tailored to the regulatory and data demands of dermatology trials

21 CFR Part 11 compliance

21 CFR Part 11–ready records with full audit trails and secure electronic signatures

Risk-Based Quality Management

Risk‑Based Quality Management aligned with ICH E6(R3) built directly into everyday workflows

CDISC-aligned data standards

CDISC‑aligned dermatology data formats, including standardized collection structures and SDTM‑compatible outputs

Global regulatory support

Submission‑ready documentation for FDA, EMA, and other global authorities

Get Started

Bring all your dermatology trial data together

See how oomnia centralizes imaging workflows, flare‑based assessments, and symptom tracking to make execution far more manageable

Talk to our team

Frequently asked questions

What is unified clinical trial software for dermatology trials?

Unified clinical trial software for dermatology trials, like oomnia, brings all dermatology‑specific workflows, imaging, lesion scoring, ePRO, visit management, documentation, and safety reporting, into one CRIS platform. It replaces scattered tools and helps teams manage the unique variability and high‑touch demands of dermatology studies more efficiently.

Why do dermatology trials benefit from a unified clinical research information system (CRIS)?

Dermatology trials generate diverse data types, photographs, investigator assessments, symptom diaries, flare logs, and lab results, while also dealing with fluctuating disease activity and high dropout risk. A unified CRIS keeps these data streams aligned, reduces manual reconciliation, and supports real‑time visibility across all sites.

How does oomnia support dermatology protocols with variable or flare‑dependent designs?

oomnia allows teams to adjust visit schedules, assessment timing, and cohort criteria through configuration, making it easy to adapt when flare patterns change, new assessments are added, or eligibility rules shift, without system rebuilds.

What systems does oomnia unify for dermatology trial execution?

oomnia combines electronic data capture (EDC), clinical trial management system (CTMS), randomization and trial supply management (RTSM), electronic patient‑reported outcomes/electronic clinical outcome assessments (ePRO/eCOA), electronic trial master file (eTMF), eletronic source data (eSource), and electronic consent (eConsent), and imaging workflows (including lesion photography and scoring) into one CRIS, ensuring all dermatology trial data flows through a single coordinated environment.

How does oomnia reduce delays caused by frequent dermatology protocol amendments?

Dermatology protocols often change due to updated scoring methods, imaging schedules, or safety requirements. oomnia handles these updates through configurable settings, preventing delays and keeping studies moving without technical interruptions.

Can oomnia manage the imaging and symptom‑heavy data typical in dermatology studies?

Yes. oomnia supports real‑time data validation and integrates lesion imagery, dermatopathology results, and patient‑reported symptoms into one dataset, reducing inconsistencies and improving data quality.

How does oomnia improve the site experience in dermatology trials?

Sites avoid juggling multiple systems by working within one interface for imaging uploads, scoring entries, ePRO reviews, visits, and documents. This cuts manual entry, reduces errors, and lightens the operational burden common in dermatology studies.

Does oomnia support multi‑center or global dermatology trials?

Yes. oomnia provides unified oversight across all regions and partners, helping sponsors manage variability in flare timing, imaging practices, patient adherence, and site readiness.

Is oomnia compliant with key regulations for dermatology trials?

Yes. oomnia follows 21 CFR Part 11, ICH E6(R3), CDISC standards, and supports dermatology‑specific regulatory submissions across FDA, EMA, and international authorities.

Can oomnia integrate imaging and dermatopathology data used in dermatology research?

oomnia natively connects imaging workflows (lesion photos, standardized scoring, central reads) with lab and dermatopathology data, giving teams a consolidated view of clinical, visual, and symptom‑based endpoints.

How does a unified CRIS accelerate dermatology trial timelines?

By eliminating data silos, automating data flow, and reducing manual cross‑system checks, oomnia speeds up site activation, improves patient‑assessment workflows, and shortens time to database lock.

Who benefits most from oomnia's dermatology‑focused capabilities?

Sponsors, CROs, and research teams running trials for psoriasis, atopic dermatitis, acne, vitiligo, rare autoimmune skin diseases, medical devices, and dermatology‑related SaMD benefit most from oomnia's unified CRIS model.

Looking to align dermatology imaging, assessments, and outcomes in one place?