Achievements
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Aligned all study management processes and implemented a global clinical trial management system for headquarter functions and all (>80) affiliates of a global organization
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Redefined Trial Master File management processes for all relevant functions and aligned the headquarter and affiliate organizations (>15,000pp) behind this critical compliance activity
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aligned resource management processes for clinical development and replaced two supporting systems with one new system following merger
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Co-developed three site identification and patient recruitment tools
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Co-developed a global patient recruitment strategy and recruitment capabilities in emerging markets
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Implemented a dedicated oncology focused organization to ensure aligned patient recruitment, professional investigator management and increased efficiency in clinical trial execution
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Implemented a global safety distribution process for SAE reporting to IRBs and investigators, using secure document exchange platforms
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Co-developed the Pharma Development Informatics Landscape, identifying future business needs and the associated systems landscape
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Implemented a new sourcing model, including offshoring of transactional activities in study management and centralization of contractor management
About
De Wilde Consulting GmbH focuses on business process optimization in the Life Science Industry.
In collaboration with our partners, we support any process optimization with offshoring capabilities and IT automation, ensuring the most efficient processes with the optimal system support.
In addition, De Wilde Consulting GmbH provides support for investigational site identification to facilitate patient recruitment, as well as general consultancy on clinical development.
Henk de Wilde
Founder and Managing Director
Throughout my professional life, I have always liked to be challenged and challenge others to achieve the best we can. I have had the good fortune of being able to do this at all positions I had, first in a pharmacy, then in a fast-growing Phase I Research Organization and lastly for many years in various positions at F. Hoffmann-La Roche.
My curiosity has allowed me to learn about the clinical development process first as project leader, then as global head of the project leaders and later as head of the oncology franchise. This last role allowed me to venture more into organizational development and process improvements, which has been my focus for many years now. Being in a leadership position has enabled me to take on all types of issues from improving patient recruitment, supporting the merger of two big companies to re-engineering the management of Trial Master File documentation. The downside of many leadership positions is that you are too far removed from the actual problems. In my role of site head for clinical operations in Basel, however, I interacted a lot with the people who do the actual work and was inspired by their enthusiasm and ownership to do the right thing for patients. This dedication is ultimately what drives any organization to success.
With the foundation of De Wilde Consulting GmbH this year, I can apply my knowledge of Good Clinical Practice compliance, my Dutch no-nonsense approach and my years of experience in business process optimization. This way I hope I can support small and midsize life science companies in finding the right balance of regulatory requirements and cost-efficient processes, ultimately allowing beneficial medicines to become available to patients faster.