Comprehensive solutions in clinical trials

Choose path below

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.

Choose

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.

Choose

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.

Choose

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.

More info

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.

More info

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.

More info

Our common success

Pure Clinical in numbers

total years of experience of Pure Clinical employees

completed clinical projects

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

successful certifications

Experienced team

Our team recommendation

Dr Katarzyna Juszczyńska, MPH

Institute of Management in Healthcare of the Lazarski University

For five years, Mr. Adam Sobantka is lecture clinical trials of medical devices at the postgraduate studies "Organization and Management of Clinical Trials at the Lazarski University. He shares his knowledge and experience with the audience with great commitment and professionalism.

Recommended to

Adam Sobantka

CEO

Kamil Gewartowski i Piotr Garstecki

Kamil Gewartowski Project Manager PCR|ONE i Piotr Garstecki, CEO Scope Fluidics S.A.

Calm, composed, to the point, she radiates professionalism and reliability. At the same time, she is a warm, cheerful, friendly and committed person. It is impossible not to like her. Driven by internal motivation and a great understanding of what to do, she is able to carry out complex tasks through the turbulent waters of interdisciplinary cooperation. He learns new things incredibly quickly and then masters them to perfection in the blink of an eye. Most importantly, it can be relied on as in Zawisza.

Recommended to