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International Clinical Trials

Perfecting Performance

The integration of the new ICH E6 (R2) guideline has created many contradictory opinions about what is necessary to be implemented as sponsor oversight in clinical trials to fulfil its requirements. Of course, sponsor oversight in general is not new, but the details to perform mandatory oversight activities and manage compliance for all clinical trial activities are still raising discussions with different opinions and solutions.

Smaller sponsor, biopharmaceutical, and medical device companies moving into early phase clinical trials are especially struggling with the definition and integration of effective study oversight to manage the quality of their research.

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Gabriele Faist has more than 28 years' pharma industry experience, with 25 years working in CROs. At the CRO, she was responsible for overseeing clinical drug development programmes, which included line management of a group made up of more than 20, including Project Leaders, Senior Project Leaders, and even Project Assistants, as well as project-related leadership of worldwide multi-functional teams to effectively implement projects, tracking the programme progress to ensure that they are being completed on time and within budget, and maintaining the quality of all work within them.

Heike Schön has more than 25 years of experience in leadership positions in international clinical research and drug development in CROs and biotechnology companies. She has a profound knowledge of clinical drug development processes and regulatory requirements from first-in-human trials to market access. As General Manager, she gained experience in leading and developing a CRO and has successfully implemented her own company, LUMIS International, as Co-Founder and Managing Director. One of her main activities is to support small biotech companies in setting up their clinical
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Gabriele Faist
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Heike Schön
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