Site Monitoring

Remote and on site monitoring in the Netherlands and Europe. Located in Amsterdam I can access all sites in the Netherlands and have quick access to the HUB Schiphol to most European airports.

Remote Monitoring

Currently most clients also request risk based monitoring: remote source document verification based on risk assessment of the sites. If needed the on site monitoring frequency can be increased based on the risk assessment.

Trial Management

Leading small teams of CRA’s, keeping track of time lines and proactively chasing issues, protocol and site training of monitors plus report review.

Preparation of study documents such as the Clinical Monitoring Plan, informed consents and essential documents.

On site qualification visits and review of monitors.

Feasibility

Approaching and chasing sites to come to a high quality selection of sites that are able to deliver the desired and eligible patients.

Start up and submission

Complete submission to EC and regulatory authority as per local standards in the Netherlands (including required templates etc.). Timely preparation and submission of all required documents to obtain a speedy approval.