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Clinical Trial Monitoring

Ourskilled and experienced Clinical Research Associates (CRAs) ensure the highest quality control and monitoring tasks during the review of data and effective interaction with study sites.  

Furthermore, our CRAs conduct the execution of the review and assurance procedures within the acquisition of the data that are essential for the correct development of the study and future conclusions. In this context, we issue periodic reports so that the sponsor is updated on a regular basis on the status of the project.

Monitoring activities include:

  • Design and Preparation of the Monitoring Plan

  • Kick-Off Meeting

  • Oversee Data Collection

  • Study start-up, Mid-Term and Close-Out Monitoring Visits

  • Preparation and Review of Reports

 

  • SAEs Management: Communication, Review, and Monitoring.

  • Ensure Regulatory Compliance

  • Resolve Data Queries as specifically requested by clients