Comprehensive solutions in clinical trials

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MD Manufacturer

As a company, we support manufacturers of medical devices within the full scope related to clinical trials on medical devices. The experience and knowledge our experts bring to the table help us provide services at a much higher level than our competition.
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IVD Manufacturer

As a company, we support manufacturers of in vitro diagnostic medical devices within the full scope of diagnostic areas. The experience and knowledge our experts bring to the table allow us to provide services at a professional level.
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Investigator

Pure Clinical is a company which supports investigators in designing, registering, conducting and finalizing clinical trials of medical devices and performance evaluation of in vitro diagnostic medical devices.
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Meet our team

About us

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

Clinical trials outsourcing

How can we help you?

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

IVD legal regulations require ongoing performance evaluation. In order to address this need, we may provide support for in vitro diagnostic medical device trials through:
  • individual approach to each project;
  • extensive base of specialist laboratories;
  • high efficacy in product certification after the end of trials through the involvement of our CRO.

MDR

MDR 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:
  • experience in many therapeutic areas, e.g., ophthalmology, cardiology, and diagnostics, e.g., virology, molecular biology;
  • excellent knowledge of regulatory requirements and standards related to clinical trials;
  • access to clinical trial sites in Europe, North America, South America and Asia;
  • highly qualified experts in the clinical, technical and functional aspects.
Areas of our expertize

Our services

Clinical Trials

We offer a full range of pre-market and post-market clinical research management services for medical devices, including regulatory strategy development, study planning, application submission and study monitoring.
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Laboratory tests

We support manufacturers in conducting laboratory tests at the initial stage of product development, including analytical, biological and other tests for pre-clinical verification of medical devices and in vitro diagnostic devices. We are committed to an individual approach to each investigational device.
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Therapeutic areas

We specialize in clinical trials in various diagnostic and therapeutic areas. Working with a team of specialists allows us to plan trials in various areas of medicine and in cooperation with trial sites specializing in a wide scope of trials.
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Our common success

Pure Clinical in numbers

75

total years of experience of Pure Clinical employees

38

completed clinical projects

12

months – reduced certification stage duration secured by Pure Clinical as compared to the competition

23

successful certifications

Pure Clinical