Clinical trials are a rigorous and scientific validation process that a sponsor’s innovative medical technology (pharmaceuticals, medical devices) must undergo to reach the market. Because safety and efficacy must be confirmed in humans at designated clinical trial institutions (hospitals), they must be approved in advance by regulatory agencies (such as the Ministry of Food and Drug Safety, MFDS) and conducted under strict ethical principles and relevant laws.
Therefore, for a successful clinical trial, it is essential to have a broad understanding of the entire clinical ecosystem—including regulatory review standards, hospital administrative systems, and the characteristics of researchers (healthcare professionals)—beyond just understanding one’s own product and target market.
The Weight of the ‘Sponsor’ as the Ultimate Decision-Maker
In general, the practical execution of a clinical trial is carried out in cooperation with specialized agencies such as Contract Research Organizations (CROs) or Site Management Organizations (SMOs). However, an important fact that must not be overlooked is that the ultimate responsibility and the consequences of all decisions in a clinical trial rest entirely on the ‘Sponsor’ (의뢰사).
Just as a basic understanding of ingredients, cooking methods, and garnishes is necessary to fully enjoy a fine course meal, the sponsor must clearly understand the overall blueprint and direction to lead and drive the process, even when delegating tasks to partner agencies, to obtain optimal clinical results.
The ‘Not Knowing What You Don’t Know’ Dilemma
However, when challenging medical technology commercialization for the first time or when lacking internal experience, sponsors often face a situation where they ‘do not even know what they do not know.’ A critical issue frequently encountered during design consulting is the false perception of ‘knowing.’
Most current clinical trial training is focused on industry professionals already executing tasks or specific specialized fields. Training opportunities for sponsors who need to see the forest and plan the whole are very rare. Even if they get a chance, it covers too broad and general topics, making it difficult to find specific answers tailored to their company’s product and situation.
By establishing a concrete direction optimized for the company’s situation in the early stages of clinical trials, sponsors can prevent incorrect budget allocations or unexpected trial-and-error, minimizing economic losses due to delays.
Find the Right Way, Together
CiKLux (https://www.ciklux.com) was founded in 2018 under the recognition that solving these issues for core personnel working in traditional CROs was necessary to turn growth into success when the bio-venture industry was rapidly growing. Over the past 8 years, we have shared many success and failure cases. Today, as we support the commercialization of medical device companies, including AI-based digital medical devices, we feel the necessity of solving these same contextual problems even more.
In a jungle-like world where the problems we want to solve continue to exist, we will continue to provide opportunities to understand the landscape through educational programs at the Korea National Enterprise for Clinical Trials (KoNECT), Seoul BioHub, regional Techno Parks, and Bio Promotion Agencies, and find the way to a solution together through individual consulting.
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