With over 20 years experience, Klinikos concentrates on Freelance Clinical Research Associate (CRA) requirements of a clinical study in Europe.
Our service does not stop at just providing a CRA CV as we wish to provide a solution to the Client’s needs which encompasses:
- Correct therapeutic experience
- Cultural and personality fit
- Regional monitoring and travel budget to Investigator Sites
Klinikos CRAs are experienced, ex-industry and work from a home office set up with computer, printer, and email facility and can
- Assist with Regulatory Submissions
- Undertake Site Management
- Manage monitoring plans, timing and logistics
- Conduct investigator pre-study meetings
- Assist the co-ordination of investigator meetings
- Conduct study initiation site visits
- Conduct regular monitoring visits / telephone contacts
- Manage adverse event reporting
- Monitor Case Record Forms (CRF) and eCRF
- Perform Source Data Validation
- Perform Drug Accountability Checks
- Perform correct/query resolutions
- Undertake study closure visits
As a niche service clinical research provider to the pharmaceutical industry, Klinikos understands the challenges presented by Investigators, Freelance CRAs and the Sponsor. Our MD has worked in Pharma, CROs and SMOs and therefore has been fortunate to see what are often conflicting requirements from all parties and how best to resolve them.
Roy Fraser - Managing Director
With over 25 years in the pharmaceutical industry
Roy has held a variety of roles in sales, marketing and R & D in Pharma, Biotech and SMOs.
Graduating in Chemistry from Glasgow University, Roy started in sales and marketing with Eli-Lilly. He then moved within the company to concentrate on the clinical and strategic development of Prozac.
In 1988, Roy became Sales Director for a Scottish Biotech – Fermentech and in 1994, Roy left to form Iatro –
a Site Management Company (SMO) that provided Research Nurses to GP practices undertaking clinical research in Scotland. Merging Iatro with Synexus – the largest SMO in Europe where Roy became Business Development Director and after 3 years promoting the Investigator Site Model, he identified a need providing monitoring resource to pharmaceutical companies with CRA headcount problems which resulted in the formation of Klinikos. With a solid background in phase II-IV studies with
Pharmaceutical Sponsors and Investigator Sites. Roy understands the needs and requirements of both camps to ensure projects are completed on time. Having that "knowledge of all sides" is invaluable to manage the interactions between Investigator Site, the CRA and the Sponsor.