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.
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