Pure Clinical is composed of top specialists with many years of experience in clinical trials: Our employees and associates have experience in conducting clinical trials across various therapeutic indications and professional experience in designing clinical trials. They also have the necessary medical, biomedical or pharmaceutical background.
We conduct the full range of clinical trials and performance evaluations, including laboratory testing. We provide the highest quality data on the market. Legal regulations can hold no secrets against us, which is why we will choose the best strategy for introducing a product to the market for you. We always have a fully individual approach to each project and the entire team focuses on ensuring that the client feels taken care of and cooperation with us is the most beneficial for them; we also respect the money and time of our contractors.
IVDR regulation require ongoing performance evaluation. In order to address this need, we may provide support for in vitro diagnostic medical device trials through:
Medical devices should be clinically tested for efficacy and safety. Due to the strict standards that must be met by such trials, we offer our many years of experience in introducing products to the market, which will allow you to do it much faster and avoid unnecessary risk. What we bring in as a CRO:
of various products for quantitative and qualitative diagnostics, studies with children on various types of samples, both prospective and retrospective
on clinical samples positive for pathogens required by CS (IVDR) or by FDA
lay user clinical performance study and lay user result interpretation supervised study to verify the operation of the device
of all types, e.g., LoD, Hook effect, Precision, Accuracy, Interferences, Cross Reactivity, Flex and Robustness
collection and storage of biological material for research purposes
full support from first-in-Human (FIH) to Post-Registry Studies of medical devices
project Management and Strategic Planning, Medical & Scientific Affairs, Audits, Trainings
study Coordinators and Clinical Research Associate (CRA) available to cooperate
for pre-clinical and restrospective studies
support in pre-clinical evidence
