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Clinical Trial Quality

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

Quality and
Compliance Staff

0 +
 Years of Experience
1 +
Clinical Trials
400 +

Regulatory Compliance with

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

We take a comprehensive approach at three strategic points in the study lifecycle:

  • Pre-study
  • Pre-baseline
  • Post-baseline

PRE-STUDY
Site Selection & Rigorous Training

Site selection is the most crucial pre-study activity for ensuring quality. We choose sites specializing in the disease under study. These sites have proven their ability to perform quality efficacy assessments, and we avoid those with ineligible patients or high placebo-response rates. Investigator efficacy assessments are highly subjective, requiring sites to collect quality, consistent data. Indero ensures high-quality data by implementing thorough and extensive training processes on the protocol, disease, and impact on patients.

Strong Expertise & Indication-Specific Training

We go beyond just protocol training. We also train our clinical research associates, clinical trial managers, and project managers on:

  • In-depth disease knowledge
  • Diagnostic modalities
  • Patient management
  • Competing medications
  • Other available therapeutic options

Trusted Partnerships with Sites

Indero’s medical disease experts provide specialized knowledge to sites, building trust throughout the study. 

  • Establishing equal partnerships with sites
  • Providing effective solutions for protocol challenges
  • Maintaining personal relationships with investigators

PRE-BASELINE
Central Review of Photos

At Indero, our pre-baseline reviews of clinical photos are a cornerstone of our central monitoring process. By reviewing clinical photographs before randomization, we ensure optimal enrollment and deliver high-quality efficacy results across various indications.

Investigator

  • Screens patient.
  • Assesses severity.
  • Takes pictures.
 

Central Reviewer

  • Reviews all screening photographs.
  • Is an independent medical monitor, not on the study.
Analysis
  • Diagnosis: Does morphology suggest the indication?
  • Severity: Does severity suggest that the patient meets eligibility criteria?
Escalation
  • Medical monitors escalate major discrepancies with sites.

POST-BASELINE
Identify Outliers

Post-baseline, we implement risk-based monitoring on selected Key Risk Indicators (KRIs) to identify outliers. Our independant medical reviewer (IMR), central monitor (CM), clinical trial manager (CTM), and medical monitor (MM) identify which KRIs to tailor to the client’s protocol. Discrepancies and outliers are promptly escalated and discussed with sites to ensure data integrity and optimal trial outcomes.

For example, we monitor: 

  • Changes in evaluator 
  • Score variance
  • Inconsistencies between scores
  • Score collection compliance and duplication

Our CM sets specific KRIs threshold to flag fluctuations, such as: 

  • Score collection compliance below X%
  • Low variability across visits (e.g., the same score for two consecutive visits or more)
  • Site with more than X% difference between two scores
  • Sites with more than two persons assigned as raters

Integrated Quality Model for Dermatology & Rheumatology Studies

Indero is dedicated to supporting dermatology and 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 and 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) and 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.

Let’s talk

Quality Services that Accelerate Studies

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

ABOUT INDERO

“Indero has been a true partner, accommodating numerous changes and consistently delivering high-quality outcomes. Their professionalism and commitment are commendable. This is a good example of the joint efforts of our teams and our fruitful partnership.”

Samuel Boube

Global Study Manager Lead & Data Privacy Champion

Frequently Asked Questions

Why is CRO quality assurance critical in clinical trials?

Quality assurance (QA) is what stands between a clinical trial and the regulatory, scientific, and operational failures that derail it. A robust QA framework ensures that data are accurate and defensible, that sites are operating in compliance with the protocol, and that any issues are caught and corrected before they compound.

In therapeutic areas like dermatology and rheumatology, where endpoints often rely on clinical assessments and patient-reported outcomes, the margin for data inconsistency is especially narrow. Without integrated quality oversight at every stage of the trial, sponsors risk costly amendments, regulatory delays, and results that can’t withstand scrutiny.

High placebo response rates are a well-documented challenge in dermatology and rheumatology trials. Subjective assessments and patient expectations can inflate apparent treatment responses in the control arm, making it harder to demonstrate a true treatment effect.

Addressing this requires quality controls at multiple points in the study life cycle:

  • Pre-study: Designing protocols with clear eligibility criteria and standardized assessment methods to minimize variability from the outset

  • Pre-baseline: Conducting central review of clinical photographs before randomization to confirm diagnosis and eligibility, reducing the risk of inappropriate enrollment

  • Post-baseline: Ongoing data review and monitoring to detect trends or inconsistencies that may signal inflated responses

Central photo review adds an independent layer of verification before patients are randomized, catching eligibility issues that site-level screening alone may miss. At Indero, an independent medical monitor reviews screening photographs to assess whether the patient’s diagnosis and disease severity align with the protocol’s eligibility criteria. Any major discrepancies are escalated to the site before randomization. This process helps ensure optimal enrollment, protects data integrity, supports cleaner efficacy results, and reduces screen failure rates downstream.

Risk-based monitoring (RBM) focuses quality oversight on the data, processes, and sites that carry the highest risk to trial integrity. Rather than applying uniform monitoring intensity across all activities, RBM uses ongoing data review and performance metrics to identify trends, flag anomalies, and direct resources accordingly. Key indicators like protocol deviation trends, screen failure rates, data query volumes, and site visit report turnaround times provide a continuous signal of where issues may be emerging. This approach improves efficiency without compromising quality and ensures that problems are addressed proactively rather than reactively.

Explore Our Monitoring Approach

Indero’s quality model covers five interconnected areas:

  • Quality control (QC) of deliverables: Monitoring visit reports, eTMF, project plans, and study data are all subject to structured QC review
  • Performance metrics: Ongoing tracking of deviation trends, screen failure rates, data queries, and financial indicators
  • Project oversight: Weekly operations meetings and continuous data review to stay ahead of enrollment and scientific issues
  • Team training: Project-specific and ongoing training to maintain protocol adherence and issue escalation standards
  • QA oversight: A robust quality management system encompassing site audits, vendor oversight, computerized system validation, and CAPA processes

Across all five areas, senior management maintains frequent oversight of key deliverables and quality indicators, ensuring accountability from the project level up.

See an Example of How We Addressed Data Inconsistencies

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Jeff Smith

Chef de la direction
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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.