INNOVADERM CRO IS NOW INDERO.

Clinical Monitoring

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

Our Risk-Based
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 monitoring services. Tell us about your clinical trial needs.

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.

FAQ

Risk-based clinical monitoring focuses oversight on the most critical data, processes, and potential risks within a clinical trial, rather than applying the same level of monitoring across all sites and activities. 

At Indero, this approach is built on: 

  • Risk assessment: Early identification of critical data and protocol-specific risks
  • Adaptive planning: Development of a cross-functional monitoring strategy tailored to those risks
  • Continuous analysis: Ongoing review of data, trends, and signals to refine monitoring activities in real time

Indero uses a hybrid monitoring model that dynamically adjusts based on study needs, site performance, and emerging risks.

Monitoring TypePrimary Focus
On-site monitoringSource data verification, process review, and site engagement
Remote monitoringOngoing data review, query management, and issue follow-up
Centralized monitoringCross-site data analysis, risk detection, and trend identification

Central monitoring is a key component of Indero’s risk-based strategy, enabling proactive identification of risks across all sites. Through centralized data aggregation and analysis, our team can detect trends, outliers, and inconsistencies. This also allows us to monitor key risk indicators (KRIs) in real time and prioritize sites or data points requiring targeted attention. 

Indero’s clinical monitoring team works as a true partner to sites, providing both oversight and ongoing operational support. 

Key areas of site support include: 

  • Protocol guidanceEnsuring clear understanding and adherence to study requirements  
  • Training and onboarding: Preparing site staff for protocol execution and efficacy assessments  
  • Issue resolution: Rapid response to queries, deviations, and identified risks  
  • Ongoing engagement: Maintaining strong communication and long-term site relationships 

Indero is structured to rapidly deploy experienced clinical research associates (CRAs) across North America, Europe, Asia-Pacific, and Latin America, typically activating resources within 46 weeks. This speed is supported by highly experienced global clinical monitoring team, many of whom bring 15+ years of industry experience, along with established relationships across thousands of sites. Indero’s CRAs are strategically positioned in key regions, enabling fast mobilization while maintaining strong local expertise and site familiarity.  

All CRAs are fully integrated into Indero’s systems, standard operating procedures (SOPs), and training programs, ensuring consistency in quality and compliance across regions. Each CRA operates under dedicated regional oversightwith support from experienced clinical trial managers to ensure continuity and performance.  

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.

“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

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.

Jeff Smith

Chef de la direction

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.