CRA Team

Klinikos was contacted by a pharmaceutical client to provide a team of experienced CRAs who could monitor a phase III cardio-vascular study across 5 european countries – France, Germany, Italy, Spain and the UK.

In this case study, the freelance CRAs reported directly to the client operations manager and Klinikos provided the CRA administration back up.

Originally, the client had used a full service CRO though the monitoring arm of the CRO was under resourced and therefore weak in the above countries.

Outcome

Working directly with the client whilst the CRO continued provided data management resources, Klinikos CRAs successfully provided and managed 8 Freelance CRAs for 84 centres across the 5 countries to recruit 1500 patients within the 15 month recruitment period.

Criteria for Success (key words – experience, therapy area)

Understanding the potential pitfalls, Klinikos identified local country freelance CRAs who had the experience of the therapeutic area and were very capable of working independently and managing their sites with appropriate communication with the client.