GCP-Service International s.r.o.

GCP-Service International is an independent ISO 9001 certified full-service Contract Research Organization, providing clinical research services for the pharmaceutical, biotech and medical device industry. GCPS’s core competencies focus on drug and medical device development using state-of-the-art technologies that support our industry-leading team members across the globe.

Since last 15 years we are heavily involved in the medical device research and development; clinical investigations currently account for a half of clinical studies performed by our teams. With MDR and IVDR burden put on the shoulders of the medical device manufacturers we strengthen our capacity of performing Clinical Evaluation preparation by establishing a network of Medical Experts in various therapeutical areas as well as by enlarging our Medical Evaluators Medical Writers team.

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One of our goals is making clinical investigations accessible, which among others means reducing unnecessary costs while uncompromising the data quality. This could be achieved by many means, i.e., proper sample size calculations, using either efficient data capture methods or proper technique of data monitoring and many others. Our success is reflected by the fact that 9 out of 10 clients choose to continue working with us after a successful completion of the first project.

Our services for medical device and in vitro diagnostic device (IVD) manufacturers:

• Clinical Evaluation Plan preparation (including the gap analysis of existing data if such needed)
• Clinical Evaluation execution incl. compilation of all documents in compliance with MDR
• Clinical Investigation preparation and execution, either as a full-service package or a functional service i.e., (selection of single services, e.g., sample size calculation and document preparation (including Clinical Investigation Plan), clinical monitoring, data capture systems and data analysis or product vigilance.
• Assessment and study of IVD functionality
• Quality Assurance services (audit, consultation, etc.)
• Medical Expertise and Advice

Feel free to approach us any time for an unbinding offer for either your clinical evaluation or clinical study.

You can check more about these topics also here: GCP-Mindset - All About Clinical Research - YouTube