We offer a full range of services related to the management of clinical trials of medical devices before placing on the market, as well as in the post-marketing phase, including the development of a regulatory strategy, study planning, support in the application and monitoring of the study. We participate in clinical trials in all phases, including pilot, pivotal, PMCF.
Our experts support clients in planning, preparing and conducting clinical trials in accordance with the requirements of ISO 14155: 2020, the requirements of the 2017/745 MDR regulation and taking into account local requirements.
As part of providing support to our clients, the Pure Clinical staff provides:
- preparation of documents necessary to obtain permission to conduct a single-center or multi-center study
- support in the preparation and evaluation of the clinical trial plan
- preparation of the research budget as well as negotiation and conclusion of contracts with a research center
- audit of the research site prior to the study and monitoring of the site during the study
- medical and administrative personnel necessary to conduct the study as well as tools for effective data collection and reporting
- support in the preparation of the necessary procedures and study documentation