Clinical and Medical Affairs
Clinical Monitoring.
Protect clinical trials through professional monitoring. We provide experienced Clinical Research Associates (CRAs) for site monitoring, remote monitoring, and trial quality assurance—in accordance with ICH E6(R2) GCP.
What risks arise from inadequate monitoring?
Inadequate clinical monitoring is one of the most common causes of critical GCP inspection findings:
- Undetected protocol deviations are becoming more frequent due to monitoring visits that are too infrequent or superficial.
- Informed consent documentation (patient consent forms) is incomplete or has not been filed in accordance with standards.
- Source data verification (SDV) is not being performed in full, resulting in inaccurate case report forms (CRFs).
- The CRAs hired lack the necessary experience with the indication and therefore focus on the wrong things.
Is the monitoring frequency for your most critical test centers truly planned with risk in mind?
Our clinical monitoring services.
We reliably cover all relevant monitoring formats—on-site, remote, and tailored to risk.
On-Site Monitoring & SDV
Comprehensive site monitoring visits in accordance with GCP: informed consent review, source data verification, protocol deviation tracking, site staff training, and issue escalation. Includes detailed reporting in accordance with the ICH E6 standard.
Remote Monitoring & Central Monitoring
An efficient combination of remote monitoring and centralized data tracking. Risk-based monitoring in accordance with ICH E6(R2): We prioritize critical data points without requiring a blanket 100% SDV effort.
Site Management & Site Relations
Professional establishment and maintenance of long-term site relationships. Support with site initiations, ongoing training of study staff, and ensuring timely data submission.
CRA Interim & Team Expansion
Flexible and responsive deployment of ENTOURAGE CRAs within existing study teams: to fill short-term vacancies, take over specific sites, or provide additional capacity during periods of high recruitment.
Frequently Asked Questions About Clinical Monitoring.
What does a Clinical Research Associate (CRA) do?
A CRA (also known as a monitor) oversees clinical trial sites on behalf of the sponsor. Key responsibilities include reviewing study documents, conducting source data verification, ensuring protocol compliance, providing on-site staff training, and maintaining regular communication with the site. They serve as the central link between the sponsor and the trial site.
What is risk-adapted monitoring?
Risk-adaptive monitoring in accordance with ICH E6(R2) prioritizes resources based on risk assessments: Which data points are critical to patients or the study? Which sites show anomalies? It uses a smart combination of on-site visits, remote monitoring, and centralized data analysis.
How often should clinical sites be visited?
The frequency is highly tailored to the study and the level of risk: during active recruitment, "high-accrual sites" are often visited monthly, while less active sites are visited quarterly. However, the initiation visit prior to enrolling the first patient and the close-out visit are always mandatory.
Can ENTOURAGE also handle international clinical trial monitoring?
Yes, absolutely. Our ENTOURAGE CRAs work throughout Europe and bring extensive experience in international clinical trial settings. For trials outside the EU, we can coordinate with trusted local monitoring partners upon request.
Additional expertise in clinical trials.
Submit a project inquiry.
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