Regulatory & Ethics Review: Before starting a clinical trial, the proposed study and device must go through a review and reporting process to ensure the safety of study participants.
Medical device clinical trials are traditionally comprised of three stages:
Exploratory or Feasibility Study: The study is conducted to establish preliminary safety and effectiveness of the medical device, and it is used to design the pivotal study.
Pivotal Study: The study is conducted to illustrate the safety and effectiveness of the medical device for a specific patient population. The results of the pivotal study are analyzed using appropriate statistical methods and they are used to gain regulatory approval to market the medical device.
Postmarket Study: The study is similar to Phase IV of clinical drug trials; it is conducted to monitor the long-term effectiveness, safety, and usage of the medical device in the general population.
Please contact us for the high-quality scientific/technical/regulatory consultancy, reporting, and filing services you may need from planning clinical trials to implementation and to post-marketing.