Investigator Sites and Monitoring

Klinikos was asked to identify 35 GP Investigator sites in the UK as part of a Phase IV depression study throughout Europe for a Pharmaceutical Client and undertake the pre study, initiation, monitoring and close down visits.

Outcome

The client appreciated that Klinikos could reduce timelines by choosing Investigator Sites with a track record (GCP trained, Research Nurse, meaningful feasibility) and regional CRA expertise. This resulted in target recruitment of 570 patients in the UK (35% of the European total).

Criteria for success (Key words – pre-qualified sites, regional CRAs)

Traditionally, UK recruitment has potentially suffered through poor Investigator selection and approval timelines. Knowing your Investigators and local approval knowledge can greatly enhance start up times and subsequent recruitment which was demonstrated in this study not only in the figures for the UK but as a percentage of the European total.