Monitoring Unit

The monitoring of a clinical trial is a key part for its correct conduct and development. Monitoring guarantees that the trial is performed, stored and published according to the protocol, the Standard Operating Procedure (SOPs) of the sponsor, the guidelines for Good Clinical Practices (GCP), and the current legislation. During the monitoring process different interested parts are involved, such as research team, CRAs, project manager and sponsor.

This is why it is very important to have a trained and qualified CRA team, to monitor the study and be the main contact person between the investigator staff and the sponsor.

In Experior we have a Monitoring Unit with qualified staff with more than 15 years of experience, that allow us to appropriately every phase of the trial, especially the early phases. We use the latest technological developments and project management tools that allow us to plan and organize all the tasks and involved roles, with special attention to risk and change management.

In Experior, CRAs receive a specific training adapted to the sponsor, therapeutic area and study phase requirements and needs and combined with our quality controls. On-site or centralized monitoring is based on risk.

Monitoring Unit expressed in figures

Studies

Countries managed

Sites managed nationally

Sites managed internationally

Methodology

  • We have a kick-off meeting with the Sponsor to ensure the establishment of the study milestones, align both teams and establish the guidelines.
  • We create study manuals (Project Management Plan, Monitoring Manual, Safety Management Plan, Drug Study Plan, etc.) in agreement with the sponsor to define the critical processes and focus the monitoring based on them.
  • We have an organized and geographically distributed CRA team to face the setbacks of daily work in a flexible and proactive way.
  • We have the ability and experience to work and manage a large number of sites and patients from different trials at the same time.
  • We schedule the initiation, monitoring and close-out visits following the project planning. 
  • Our project management platform allows us to know in real time the status of the project (global and per site recruitment status, monitoring visits and co-monitoring visits performed, notifications to EC/CA performed, etc.)
  • We perform remote monitoring periodically that allows to identify the riskiest sites (risk-based monitoring) and select them to perform on-site monitoring visits.
  • We perform co-monitoring visits to guarantee the quality of work of our CRAs.
  • We inform the sponsor in real time about the study development and the evolution of each site (issues, doubts of the investigator staff, protocol deviations, serious non-compliance, etc.).
  • We offer recruitment activation techniques if necessary.
  • We establish internal deadlines in different monitoring procedures (delivery of monitoring reports, notification of protocol deviations, etc.) to guarantee compliance with the Standard Operating Procedures, as well as to guarantee a high quality of performance.

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