for MDR Compliance
Ensuring clinical data compliance with the latest Medical Device Regulation (MDR) is critical for medical device manufacturers to maintain their ability to market and sell their devices in Europe.
Our Clinical Data Services are designed to help medical device manufacturers achieve and maintain MDR compliance with ease and confidence.
Clinical Data Collection
Our clinical data collection services include protocol design, site selection, and patient recruitment to ensure efficient data collection. We work with you to design a study that meets your needs and the requirements of MDR.
Clinical Data Management
Our experienced team provides comprehensive data management services, including data entry, cleaning, validation, and storage. We use industry-standard tools and processes to ensure that clinical data is of high quality and meets regulatory standards.
Clinical Data Analysis
Our team of experienced statisticians can assist with statistical analysis and report generation, providing insights into the data and supporting regulatory submissions. We use the latest techniques and methods to ensure accurate and reliable results.
Post-Market Clinical Follow-up (PMCF) is a systematic process that involves planning, implementation, data collection, analysis, and reporting. PMCF is an essential component of the ongoing evaluation of the safety and performance of medical devices in Europe and must be carried out in accordance with the relevant provisions of the Medical Device Regulation (MDR).
PMCF step by step
Planning ► Implemation ► Data collection ► Data Analyses ► Reporting
Clinical study is a controlled investigation of a medical device in human subjects to gather data on its safety, performance, and effectiveness. The results are documented in a Clinical Evaluation Report and must demonstrate compliance with MDR requirements. Clinical studies must be conducted in accordance with Good Clinical Practice and approved by an ethics committee.
Clinical Study step by step
Planning ► Ethic Approval ►Implemation ► Data collection ► Data Analyses ► Reporting
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CLADE-IS represents an information system for clinical data warehousing. Researchers in health and life sciences industry use this EDC platform (Electronic Data Capture) for secure and intuitive data management. CLADE-IS is in compliance with ISO 13 485.
Comparison of Electronic Data Collection (EDC) System vs. Paper Data Collection:
CLADE-IS
Faster data collection and entry 
Real-time data availability and analysis
Reduced errors and improved data accuracy
Improved data management and security
Better ability to monitor data quality
Reduced paper usage and waste
Paper Forms
Slower data collection and entry
Delayed data availability and analysis
Increased errors and data inaccuracies
Poor data management and security
Limited ability to monitor data quality
Increased paper usage and waste
The Institute of Biostatistics and Analyses is an investigator of the project “Extending services portfolio of an information system for the data management in clinical research”. The project is supported by the OP EIC from the European Union funds.
Main objective of the project is the development of a platform for composition of information systems focused on data management and data mining in the field of pharmaceutical industry and life sciences. Offer of digital services based on a developed and validated information system will make reliable analytical models accessible to the companies for their decision-making and precise information sources for regulatory bodies. The project steps out of a laboratory environment of clinical trials and focuses on the evidence supported by real-world data.
