In the minds of young companies from the pharmaceutical or medical device sector, clinical trials lie somewhere in the future and are at best perceived as a necessary evil. Even the fact that clinical trials are part of the largest cost block of product development and take up a considerable part of the remaining patent term is acknowledged by the companies and their investors with a maximum shrug of the shoulders. Sven Engel at SynapCon explains how clinical registration studies are not pharmacological phase I or phase II studies in a 100 % controlled environment, but an organisational, highly complex and decentralised project with a large number of actors.
Extract:
Clinical Trials – Somewhere Between Tradition and Digital Modernity – A Wakeup Call
Dr. Jonson’s equation obviously did not work out. Clinical registration studies are not pharmacological phase I or phase II a studies in a 100 % controlled environment, but an organisational, highly complex and decentralised project with a large number of actors. Small mistakes in the set-up can quickly scale up to massive problems. Such a project is teamwork, regardless of the degree of organisational and technical optimisation, today and in the future.
Phantom – Patent Pain
In the minds of young companies from the pharmaceutical or medical device sector, clinical trials lie somewhere in the future and are at best perceived as a necessary evil. Even the fact that clinical trials are part of the largest cost block of product development and take up a considerable part of the remaining patent term is acknowledged by the companies and their investors with a maximum shrug of the shoulders.
It seems to be a mantra, even a belief, that clinical trials are expensive, take a long time and regulatory requirements are the main culprit. This mantra, nourished by constant repetition, turns out to be a self-fulfilling prophecy, injected into the young companies by consultants, often former employees of the large research companies, who never had to worry about the size of their budgets.
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