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Clinical Monitoring

Risk-based clinical monitoring services that ensure dermatology and rheumatology clinical trials run according to protocol and regulatory requirements.

Clinical Monitoring Team Members

0 +
 Years of Experience
1 +
Clinical Trials
50 +

Our Risk-Based Clinical Monitoring Approach

To ensure participant safety, data integrity, and trial success, our clinical monitoring team undergoes the same training and testing as investigators for efficacy assessments (EASI, IGA, PASI, SALT, etc.). This rigorous training enables clinical research associates (CRAs) to quickly identify potential risks and escalate them to skilled clinical trial managers, ensuring a deep understanding of the efficacy evaluations they monitor. Also, our clinical monitoring team follows an adaptive (risk-based) approach, which emphasizes on-site monitoring efforts informed by the review of identified critical data and processes, issues, and trends. As a niche CRO specialized in dermatology and rheumatology, our CRAs and central monitors are highly trained and experienced in these therapeutic areas.

Risk Assessment
We systematically evaluate critical data and process risks associated with the protocol.

Site Management 
We develop a unified, cross-functional plan to monitor identified trial risks.

Continuous Analysis
We integrate emerging risks, iteratively adapt the monitoring plan, and improve oversight in real time.

On-Site Monitoring 
We investigate and address emerging process-related risks and concerns that can only be performed on-site.

Remote Monitoring
We remotely investigate and address emerging process or data-related risks and concerns.

Central Monitoring
We aggregate and analyze data to identify risks and trends and provide direction to monitoring activities.

 

Clinical Monitoring Team Experience

Experience

The average clinical monitoring team member has over 15 years of industry experience working in the clinical research industry.

 

Established Relationships

Our team has established working relationships with thousands of dermatology and rheumatology sites, making on-site monitoring visits seamless. Our familiarity with site processes fosters site engagement and recruitment.

Partner with Indero’s Clinical Monitoring Team

Indero is a dual focus CRO for dermatology and rheumatology clinical trials that ensures study compliance through risk-based clinical monitoring services. Tell us about your clinical trial needs.

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A Closer Look at Our Clinical Monitoring Services

Learn more about how our clinical team works with our adaptive clinical monitoring approach.

Site Monitoring Visits

  • CRAs are trained by the medical team on your study protocol. 
  • Targeted Source Data Verification (SDV) combined with Source Data Review (SDR) to ensure data collected is accurate, complete, and compliant with the protocol, regulations, and Good Clinical Practices (GCP).
  • First monitoring visit promptly after first randomized subject at each site.
  • A combination of on-site and remote visits tailored to the needs of the study.

Site Management

  • CRA provides oversight and guidance to ensure site adherence to study protocol.
  • CRA maintains site engagement and provides recruitment support.
  • CRA responds to mitigations required based on risk-based monitoring schema reviewed by the Clinical Trial Manager.
 

Centralized Monitoring

  • Review and escalation of Key Risk Indicators and signals across sites to detect patterns and outliers.

Adaptive Clinical Monitoring Services that Accelerate Studies

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

ABOUT INDERO

“My work experience with Indero has been very positive. Their monitoring support has been crucial in achieving our research goals. So far, this partnership is a true success story. Their professionalism and expertise are commendable.”

Assoc Prof. Beata Imko-Walczuk

Copernicus Medical Center, Gdansk

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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.

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Jeff Smith

Chef de la direction
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Jeff Smith, Chef de la direction d’Indero Recherches, apporte prĂšs de 30 ans d’expĂ©rience dans l’industrie pharmaceutique et CRO, s’Ă©tant distinguĂ© par son leadership exceptionnel, sa vision stratĂ©gique et son innovation. L’expertise de Jeff couvre des opĂ©rations mondiales, la gestion de la croissance, ainsi que la promotion d’une culture d’entreprise collaborative. Ses atouts en matiĂšre de crĂ©ation de valeur, de gestion des partenaires et d’opĂ©rations CRO ont toujours contribuĂ© au succĂšs dans ses fonctions prĂ©cĂ©dentes. Sous la direction de Jeff, Indero continue d’étendre ses capacitĂ©s, faisant progresser les connaissances mĂ©dicales et les nouvelles thĂ©rapies en dermatologie et en rhumatologie.

Revolutionize Your Topical Trials

Efficacy insights in days, not months.

 Indero’s Early Phase 1 model enables sponsors to initiate topical studies that detect early pharmacodynamic signals much sooner than traditional phase 1, using microdosing and transcriptomic analysis. This approach reduces preclinical requirements, shortens study duration from 8–12 weeks to ≀3 days, and lowers costs, helping teams make informed go/no-go decisions faster.
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