20. marraskuuta 2024

avoid-unnecessary-clinical-trials

A clinical device trial is almost essential for bringing devices to market in compliance with the MDR. However, it should be conducted carefully and only to the extent necessary. Thorough and comprehensive preliminary work can significantly save costs and time.

A key part of planning an appropriate device study is a well-prepared Clinical Evaluation Plan (CEP). Essential materials for preparing the CEP include existing information from the manufacturer and clinical data obtained from a literature search. By comprehensively collecting existing clinical data through a literature search, the scope and focus of your own study can be defined and limited.

Clinius has developed an application based on OpenAI’s generative AI and large language model (LLM) to assist in conducting comprehensive literature searches. Utilizing this application, it is possible to carry out extensive literature searches more cost-effectively.

By combining the information already available from the manufacturer with the data obtained from a comprehensive literature review and conducting a critical clinical evaluation of these by our medical specialists, a clear picture of any additional clinical data that may be needed can be obtained. Based on this, a well-defined clinical study can be planned if deemed necessary according to the evaluation plan.

So, avoid unnecessary clinical studies. Contact us today!