Comprehensive services for
clinical sample collection
and for IVDR certification
CRC is a company with years long experience in managing and conducting clinical trials in Czech Republic and Slovakia. With increasing importance of “biobanking” and the new requirements for certification of in diagnostic medical devices according to the IVDR regulation, our company has decided to extend the range of offered services and to provide its professional know-how to biobanks and IVD manufacturers as well.
Contact UsOur goal is to assist the biobanks with prospective biological sample collection. We have a large network of medical centers, which allows us to collect samples from a big number of patients in a short period of time. With our experience in clinical trialas and a well-trained team of experts, we are able to provide comprehensive solutions that involve sample collection, temporary storage, analysis, and transportation of biomaterial in compliance with strict ethical and regulatory standards.
In relation to the new IVDR regulations, which define even stricter requirements for the validation of CE IVD (in vitro) diagnostic medical devices), we offer our services to IVD manufacturers. With our detailed knowledge of the legislative framework of Regulation (EU) 2017/746 of the European Parliament and of the Council and the submission of relevant documentation, we assist the manufacturers of in vitro diagnostics to meet the IVDR requirements. Our know-how also includes the preparation of all documentation for IVDR, including clinical evaluations and the Performance Evaluation Plan (PEP).
Services
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IVDR documentation
We prepare the documentation package in accordance with the European Parliament and Council Regulation (EU) No. 2017/746 (IVDR) and arrange its submission to the ethics committee and the relevant regulatory authorities.
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Sample collection
Thanks to our efficient network of CRC (Clinical Research Center) medical centers, we can obtain a significant quantity of various types of clinical samples in a short period of time.
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Validation of CE IVD Kits
We verify the performance evaluation of IVD kits in accordance with requirements of IVDR regulation, which places a great emphasis on clinical data and product safety.
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Analysis of samples
We verify the quality and parameters of collected samples, analyze their physiological and biochemical properties, we control the sample labeling, and assess other necessary characteristics.
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Recruitment campaigns
We know how to recruit a large number of patients by using the effective recruitment campaigns on social media, which offer the opportunity for extensive and precise targeting of specific subjects.
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Storage of samples
We offer temporary storage of biological samples in Ultra Low Temperature Freezers with 24/7 temperature monitoring (-80 °C).
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Shipment of biomaterial
We can arrange a safe and controlled shipment of biological samples between collection centers, laboratories, and biobanks in cooperation with specialized shipment services.
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Data management
We provide statistical analysis of clinical data, preparation of Case Report Forms (CRFs), and monitoring in collaboration with professional local partners.
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Why CRC Biosamples?
We have been on the market in Czech Republic and Slovakia since 2016.We have access to a large number of patients through our established network of medical facilities, Clinical Research Center (CRC).In our network of medical facilities, we have access to a large number of patient, which enables us to obtain a substantial amount of biomaterial and validate a significant number of IVD kits within a short time frame.Our CRC network has more than 120 doctors with experience in clinical trials in Czech Republic & Slovakia. We closely cooperate with selected hospitals & clinics.Fast sample collection is supported by implementation of patient recruitment campaigns on social media.We have a good knowledge of local legislation, requirements for the validation of CE IVD kits and the collection of biological samples.We can prepare a documentation package in accordance with Regulation (EU) 2017/746 (IVDR) on in diagnostic of medical devices and ensure its submission to the ethical committee and relevant regulatory authorities.We are familiar with the local legislation, documentation preparation, and requirements for the identification and labeling of collected biological samples. Ethical and legal requirements are crucial factors in our work.We have a qualified team with long-term experience in management, coordination, and execution of clinical trials.We cooperate with local partners who can provide cost effective statistical calculations, CRF (Case Report Form) preparation, and monitoring services.We have a long-term cooperation with selected certified laboratories from the Czech Republic and Slovakia.Collected biological samples are stored in Ultra Low Temperature Freezers with continuous temperature monitoring at -80 °C. Our Lab Freezers are operated by trained staff 24 hours a day, seven days a week.We are a member of SCRS (Society for Clinical Research Sites) and frequently (actively) participate in international congresses oriented to research and development in field of biomedicine. We are constantly improving our processes.We are developing an effective quality management system that is regularly audited and certified according to ISO 9001:2015 standard. We follow the principles of Good Laboratory Practice (GLP).OUR EXPERIENCES
In 2022, Clinical Research Center team successfully completed 5 clinical studies of Covid antigen kits in Slovakia. We have enrolled 630 patients in 5 weeks. We promptly prepared the document submission to regulatory agencies, taking advantage of our knowledge of local regulations and requirements for kit testing and sample collection.
One of our main strengths is our ability to collect biological samples from a large number of patients in a relatively short time. Our network of more than 120 physicians are experienced in clinical studies and are based across many regions in Czech Republic and Slovakia. Due to various specializations of our doctors, we have access to many patients with different indications.
One of our recent projects was focused on collection of different types of swabs from approximately 1000 patients with symptoms of acute respiratory infections. Clinical Research Center team managed this study precisely according to the study sponsor's requirements, including the temperature controlled temporary storage of biological samples.
Swab samples, as well as other biological materials, are always stored in 24/7 temperature-controlled freezers at -80 degrees Celsius.
We have good long-term collaboration with selected laboratories which perform different sample analysis, allowing us to offer wide range services for clinical studies, diagnostic kit testing, and biologic material collection. If you are looking for a reliable partner for your study, contact us - Clinical Research Center team!
Certification
Cert No. 16864-QMS ISO 9001
The management system of Clinical Research Center s.r.o. is certified in accordance with ISO 9001:2015.
In 2018, Clinical Research Center s.r.o. successfully completed the certification process for management system of services in project management and coordination of clinical studies in accordance with ISO 9001:2015. Within the certification audit, Alcumus ISOQAR established the requirements of the above standard have been met.
In 2022, we successfully went through the recertification process.
The implemented management system of Clinical Research Center s.r.o. is one of the means that guarantee stability, quality and reliability of the services provided to our customers.
The management system of Clinical Research Center s.r.o. is in accordance with the organization strategy and emphasizes employee development and their active participation in continuous improvement of company activities. Risk analysis at all company levels is a significant area, together with the processes related to understanding the requirements of the customers and stakeholders.