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International Clinical Trials

Does Size Matter?

CROs of different sizes are recognising the increasing need for small sponsor companies to get support in conducting clinical trials. Generally, these CROs, even the smaller ones, have a larger organisation than the small sponsor companies.

Most of the small sponsors depend on external funding, like venture capital, private equity, public funding, or funding through large pharmaceutical companies. They depend on being extremely cost-effective in conducting their clinical trial, with limited resources to perform their vendor oversight and management. One single clinical trial can be a ‘make or break’ milestone for the small sponsor companies. Single achieved milestones, like the positive approval of the clinical trial submission, the timely ‘First Subject In’, creates shareholder value, positive press releases, and awareness for potential investors. The outcome of the clinical trial, the achieved company milestone, can be an indicator for the success of the next financial investment round.

The business model for small early clinical stage sponsor companies is not to make revenues, but to develop innovative compounds which can be sold or partnered profitably at different stages of the drug development cycle before market authorisation. Small sponsor companies are known for their innovation, flat hierarchies, and, sometimes, unconventional decision-making processes.

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Heike Schön, Managing Director at LUMIS International, 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, Heike gained experience in leading and developing a CRO, which she implemented successfully at LUMIS International. One of her main activities is supporting small biotech companies in setting up their clinical research department and oversight management.
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Heike Schön
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