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Clinical Trial Management

Site Monitoring

Your data is only as good as the oversight behind it.

At Althian, we approach monitoring not as a checkbox exercise but as a genuine quality assurance function β€” one that protects the integrity of your study from the first site visit to the last.

Our Approach

We monitor so problems get solved
before they become problems.

Our monitoring team combines scheduled on-site visits with remote oversight β€” the right balance determined by protocol complexity, site performance, and sponsor preference. Every visit is documented, every finding is tracked, and every issue is followed up until resolved.

How We Monitor

On-site and remote β€” the right balance for your study.

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On-Site Monitoring

For complex protocols, high-enrollment sites, or studies that require close hands-on oversight, our monitors conduct regular in-person visits to verify source data, review regulatory documentation, and assess site compliance in real time.

  • Source data verification
  • Regulatory binder review
  • Investigational product accountability
  • Protocol deviation identification
  • Site staff support and training
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Remote Monitoring

Where protocol complexity and site performance allow, we leverage remote monitoring tools to maintain continuous oversight between on-site visits β€” reducing costs and timelines without compromising data quality.

  • Remote source data review
  • Real-time data query management
  • Enrollment and compliance tracking
  • Risk-based monitoring signals
  • Continuous site communication

Our Process

From first visit to final close-out.

Hover over each step to learn more

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Site Initiation Visit
We conduct a thorough site initiation visit to train staff, verify readiness, and ensure the site is fully prepared before the first patient is enrolled.
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Routine Monitoring Visits
Regular on-site and remote visits throughout the study to verify data, review documentation, and ensure ongoing protocol compliance at every site.
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Issue Tracking and Resolution
Every finding is documented, tracked, and followed up until fully resolved. We maintain a transparent issue log that sponsors can access at any time.
βœ…
Site Close-Out
We manage the full site close-out process β€” ensuring all data is reconciled, documentation is complete, and the site is properly closed in compliance with regulatory requirements.

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