Clinical Consulting

Clinical data of a product is essential for receiving the requisite approvals and licenses such as product license, new medical technology assessment, as well as MRP listing, for the Korean market. However, each relevant agency has its own purpose in reviewing the submitted clinical materials to provide their authorized approval. For example, the MFDS confirms the safety and efficacy of the clinical data submitted, while HIRA would review the cost-effectiveness and patient approval/experience with a particular clinical data.

Thus, we can provide an effective clinical trial plans for the requisite approvals in Korea, based on the characteristics of the clients’ products.

We provide detailed service on clinical trials as follows:

  • Provide advice on laws and regulations that would apply in clinical trials;
  • Contact institutions and discuss the clinical trials to determine method of clinical trial, for example, an exclusively conducted at a single institution or at multiple institutions;
  • Provide consulting and advice on drafting clinical trial protocol as well as MFDS IDE approvals;
  • Provide advice on clinical trials using medical data and RWEs to receive the requisite approvals;