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International Clinical Trials

Value Added

TODAY’S CHALLENGE

Over the past 20 years, the pharmaceutical service industry has witnessed a dramatic change in the complexity of the compounds being developed and investigated. Along with this complexity came the rationalisation of resources and core competencies in the large and not-so-large pharmas and biotechs, increasing the need for outsourcing the development of speciality assays and biomarkers. With the rapid evolution of molecular biology, immunology and genetic science, finding a competent laboratory with the qualifications and experience to meet the R&D objectives for preclinical and clinical development is a challenge for most drug developers.

Specific esoteric assays are often required to measure not only compound activities and their optimal concentration in specific matrices, but also related actions such as antibody activities, their neutralising effect, chromosomal aberrations, mutations or deletion. Listed below are a few examples of most common needs. Bioanalytical assays such as HPLC or gas chromatography methods have only limited application when looking at large molecules or biomarkers.


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Anne Marie Gaulin has over 20 years of experience in pharmaceutical and contract research organisations in management positions ranging from sales, marketing, business development and operation. Anne Marie is currently the Senior Director, Business Development at CIRION Clinical Trial Services, a contract research laboratory offering global central laboratory and development and validation services to the biopharmaceutical industry worldwide.
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Anne Marie Gaulin
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