Case Studies
Klinikos has worked successfully with a variety of Pharma clients to provide tailored solutions to their needs. The following case studies show examples of real-life projects outlining the remit, steps taken by Klinikos, outcome and criteria for success.
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CRA Team - Provision of a CRA Team for Cardio-Vascular Study
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.
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CRA Team and Management
Klinikos was asked to provide and manage a team of 4 regionally based freelance CRAs in the UK to support the Client’s in house medical team. One key factor was the need for the Client to maintain control of a Phase III endocrine study and keep strong links with Investigators for future studies.
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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.
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Site Management
As Klinikos has an Investigator Group of Sites (GPs) in community based medicine, we were asked to use this group to facilitate recruitment in a phase IV study in gastroenterology. The pharmaceutical client had monitoring resource but lacked good quality sites in the UK.
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GCP Investigator Training
An NHS Client had identified clinical researchers in their Trust involved in phase II - III studies. On examination of the study site teams, it was evident that over 80% of the personnel had little or no GCP training and some sites had started recruitment.
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EDC Investigator Training and Recruitment
A Pharmaceutical client required 110 GP Clinical Investigator centres in the UK and Ireland to participate in a long term phase IV risk factor drug study. Klinikos was briefed by the marketing department of the company to identify, select, initiate and monitor the sites.
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