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Qualified Matters

Clinical trials are conducted in research settings, designed to answer specific questions about biomedical or behavioural interventions, including new treatments – such as novel vaccines, drugs, dietary choices and supplements and medical devices – as well as known interventions that warrant further study and comparison. They generate critical data on safety and efficacy, which is then submitted to the regulatory authorities responsible for vetting the risk versus benefit ratio of the trial.

As the demand for new therapies and treatments persists, the need for clinical studies expands globally. This comes with a growing need for organisations to ensure they are able to design, start up and execute their trials, thus delivering critical information regarding the results.

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Marquard Lett is Senior Advisor at UL Compliance to Performance and has over 38 years’ experience in highly regulated industries, including the pharma industry in manufacturing, training and qualification systems, training quality systems and business and manufacturing process improvement.

Gordon Elger
is Senior Advisor at UL Compliance to Performance and has more than 30 years’ experience in the pharma industry in R&D, manufacturing, regulatory affairs, compliance and document management. He has been responsible for regulatory submissions and liaison with agencies at scientific advice meetings, leading the design and implementation of document management systems and is fully conversant with GxP requirements. Email: gordon.elger@ul.com
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Marquard Lett
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Gordon Elger
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