INNOVADERM CRO IS NOW INDERO.

Clinical Trial Quality

Integrated quality assurance processes and training to ensure high-quality data in dermatology and rheumatology clinical trials.

Regulatory Compliance with

ICH logo
EU clinical trials register
HIPAA compliant
FDA 21 CFR Part 11
European Medicines Agency logo

Data Integrity: How Do We Mitigate High Placebo Response Rates in Dermatology & Rheumatology Clinical Trials?

  1. Pre-study
  2. Pre-baseline
  3. Post-baseline

Integrated Quality Model for Dermatology & Rheumatology Studies

Indero is dedicated to supporting dermatology & rheumatology clinical trials with high quality standards from a scientific, operational and compliance perspective.

Quality Control of Every Deliverable

  • Monitoring visit reports review
  • eTrial master file
  • Project plans
  • Monitoring oversight (+QC visits)
  • Study data

Performance Metrics

  • Site visit reports turnaround time
  • Protocol deviations trends
  • Screen failure & drop out (rates, trends, reasons)
  • Data queries
  • Financial performance indicator

Project Oversight

  • Weekly CRO operations meetings for analysis of study trends, enrollment projection, and scientific/medical issues
  • Ongoing data review

Team Training

  • Project-specific training (study and sponsor-specific requirements)
  • Ongoing training during project team meetings (ongoing data review, issue escalation, action items)

Senior Management Oversight

  • Frequent project review on key project deliverables and performance metrics
  • Address ongoing issues/actions planned
  • Frequent executive performance review meeting
  • Review of Quality Indicators

Quality Assurance Oversight

  • Robust quality management system
  • Global site audit programs
  • Solid vendor oversight based on risk
  • Computerized system validation
  • Study audits (e.g., TMF, CSR)
  • Non-conformance (NC) & corrective and preventive action (CAPA)

Partner with Indero’s Quality Assurance Team

Indero has over 25 years of experience in meeting sponsor expectations with high quality, compliant clinical trials. Tell us about your project today.

Quality Services that Accelerate Studies

Scientific discipline. Operational efficiency. Clinical development expertise. Our quality assurance services provide the rigorous foundation, quality data, and expertise clinical trials need to ensure effective execution and on-time delivery.

“Working with Indero for our alopecia areata trial has been a smooth and exceptional experience, marked by their extensive expertise, proactive approach, and seamless collaboration.”

Duong Nguyen head shot

Duong Nguyen

Head of Clinical Operations

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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.

Is Now

We are excited to announce that Innovaderm is rebranding our CRO division as Indero (in-dAIR-oh). This rebranding reflects our ongoing commitment to innovation and our expansion into the field of rheumatology, a therapeutic area closely linked to dermatology. As a dual-focus CRO specializing in both dermatology and rheumatology, this strategic decision marks a significant milestone for our organization, and we are eager to embark on this new chapter with our valued partners and clients. Additionally, our Clinical Research Unit (CRU) will keep the name Innovaderm and will continue to conduct dermatology studies.

Site Selection & Management

Our long-standing relationships with key opinion leaders and highly performing sites, result in optimized start-up processes that deliver strong results in the least amount of time. As part of our site evaluation, our team utilizes past performance metrics, recruitment projections based on competitive landscape, and detailed feasibility surveys to determine a site’s capabilities and interest in a study.

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Patient Recruitment

Our dedicated patient recruitment and advertising team integrates with the study team to tailor recruitment strategies, customize central ad campaigns, develop advertising creative, and continuously track and adapt recruitment goals. Our patient-centric approach is enhanced by Clinago, our technology enabled recruitment service.

PROJECT MANAGEMENT

We orchestrate all study activities and deliverables, including site selection process, budget and contract negotiations, and patient engagement, recruitment enrollment projections, all while respecting your study timelines.

PROJECT MANAGEMENT

We orchestrate all study activities and deliverables, including site selection process, budget and contract negotiations, and patient engagement, recruitment enrollment projections, all while respecting your study timelines.