Case Studies

Clinical Research Associate Team

Example 1

 Klinikos was asked to provide a team of 4 regionally based freelance Clinical Research Associates 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.

 Regular direct communication throughout the study between the Freelance CRAs, Investigators and the client allowed excellent relationships to foster between all parties. Key to the success of this project was the Sponsor’s ability to integrate the Freelance CRAs into the Medical Department and treat them as if they were employees of the company.

Example 2

Klinikos was approached to provide 7 CRAs for a Medical Device Sponsor in Bulgaria, Hungary, Austria, Germany, Poland, Spain and UK. This was for a pivotal cardiology study with 190 patients. Crucial to the success of this study would be the choice of Freelance CRAs who not only had a background in cardiology but medical device experience that would prove to be an advantage when dealing with Investigators and reporting of not just Adverse events but also Adverse Device Effects.

Not only did this study complete on time, the Sponsor offered the team to come on board as full time employees of the company.

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 (7 countries) for a Client and undertake the pre study, initiation, monitoring and close down visits providing 3 regional Freelance CRAs with suitable experience in this condition and depression scales.

Selecting Investigator Sites that had GP Investigators experienced in Depression studies with the appropriate Research Nurse resource with a proactive attitude to recruitment resulted in target recruitment of 570 patients in the UK (35%of the total recruitment plan)

EDC Investigator Training and Recruitment

A Pharmaceutical client required over 300 GP Clinical Investigator Sites in Europe and 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. In addition, the Client requested a team of 16 Freelance CRAs to cover 8 European countries involved in the study.

Klinikos identified the appropriate number of Investigator Sites from our pre qualified data base resulting in the successful recruitment of over 12,000 patients in Europe. An unexpected but welcome result of using a Freelance CRA model in Europe was the reduction in the monitoring cost aspect of the study by 15% compared to using a full service CRO that was initially tasked to undertake this study.

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