Clinical Trials

We offer a full range of services through our Pure Clinical team related to the management of premarket clinical trials for, as well as in the postmarket phase. Our services include the development of clinical trial-related regulatory strategies, study planning, and support in the application and monitoring of clinical trials. We participate in all phases of clinical trials, including pilot, pivotal, and 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 while taking into account local requirements.

At our ISO and CLIA certified laboratories in the United States and Europe our clinical staff will support you in producing the clinical data necessary to complete your application. Our global biobanks and international network of sample collection sites provide us with the clinical samples needed for successful testing.

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 research budgets as well as negotiation and execution of contracts with research centers,

Auditing of research sites prior to studies and monitoring of sites during studies,

Providing medical and administrative personnel necessary to conduct studies as well as tools for effective data collection and reporting,

Supporting preparation of the necessary procedures and study documentation.

Laboratory Tests

Pure Clinical has a network of research and diagnostic laboratories with a diverse profile of activities, that rank among the leading trial sites in Europe and the United States. The sites in our network meet the highest standards for clinical trial quality based on our numerous national and international certificates(e.g., ISO 9001, ISO 15189, ISO 17025, accreditation of the Polish Accreditation Centre, EMQN, NEQAS, GenQA and EQA certificates).

Laboratory Testing Areas

Oncology

Analysis of biomarkers used in cancer diagnostics, including lung, ovary, breast, melanoma or colon cancer, examination of hereditary lesions, and gene mutations.

Infectious diseases

Diagnostics of SARS-CoV-2 infection and detection of HIV, HCV, HBV, and EBV.

Microbiology

Detection of pathogenic bacteria in sample material, detection of genes, determining antibiotic resistance, and molecular typing of microbial strains.

Genetics

Whole genome sequencing, RNA sequencing, sequencing of the SARS-CoV2 virus genome, evaluation of tumour tissues by molecular cytogenetics, and diagnostics using the PCR technique.

Biological assessment

Biocompatibility assessment of medical devices based on the requirements of the EN ISO 10993 standard.

Therapeutic Areas

Pure Clinical works with many experienced trial sites conducting medical device clinical trials in Europe, the United States, and China.

In each of the cooperating trial sites, we have experienced medical and administrative staff, which allows us to efficiently conduct the trials and collect valuable clinical data. Each of the sites conducts trials based on their specific research procedures and quality management systems. Medical equipment used for each trial has been carefully evaluated to ensure the rapid collection of high-quality test results, without the risk of data loss.

Research capabilities of cooperating sites – Therapeutic areas for our
medical device clinical trials:

Oncology (gynaecology-oncology)

Gynaecology

Dermatology

Vaccination Trials

Contrast Agent Trials

Orthopaedics

Allergology

Angiology

Immunology

Cardiology

Neurology

Rheumatology

Infectious diseases

Diabetology

Endocrinology

Gastroenterology

Laryngology

Nephrology

Pulmonology

Family medicine

Imaging Diagnostics

Preperation of Anonymized Data for Artifical Intelligence