Clinical Data Management & Biometrics CRS Clinical Data Management & Biometrics Department provides all the services necessary to handle the data of clinical trials and of treatment observation studies at consistently topmost quality and in full compliance with all regulations concerned, e.g., CFR 21, part 11. This has been confirmed by internal GAMP4* and GAMP5* validation. Data Management The highly qualified CRS data management team relies on more than three decades of experience in delivering continuously high-quality data. The team is at ease in working based on Sponsor’s or CRS‘ SOPs. In addition, the CRS team is also familiar with integrating sponsor-specific templates. Capable to handle large quantities of data efficiently, the CRS team supports data expertise in every phase of early drug development such as collection, organization, validation, and quality control of clinical trial data. The services of the CRS data management team can be contracted as part of a clinical trial or as a stand-alone service. At CRS we are extensively experienced with CDISC standards, including Gold Membership. Data management includes the SDTM* standard in its processes, starting from the electronic Case Report Form (eCRF) until final data delivery. With the Medrio Remote Data Capture (RDC), the CRS team has a customizable and perfomant RDC system in place to assure a high data standard and high quality. The system includes medical coding with the Medical Dictionary for Regulatory Activities (MedDRA) and the World Health Organization’s Drug Dictionary (WHO DD). The Statistical Analysis System (SAS) programmers have long standing experience with CDISC standards. The CRS data management team works on at least 10 to 15 trials per year in early phase and is used to handle and evaluate data in all relevant formats. In all this CRS complies with our customers’ project schedules while meeting the highest standards of quality in the most efficient, cost-effective manner. Biometrics The experienced, well-trained CRS team provides statistical analysis and programming adhering to both clients’ project requirements and ICH guidelines for successful trial evaluation. In addition, attention is paid to process optimisation while focusing on maximum results. Data analysis is performed using industry-standard SAS® software as well as WinNonlin and R Foundation for Statistical Computing (Staburo). Implemented Software The software in use at the CRS Clinical Data Management & Biometrics Department is fully validated, ensuring that every phase of our customers’ trials is correctly focused for maximum results. An important part of CRS’ range of services is to deliver trial data and report it in the form of electronic Common Technical Documents (eCTD) complying with the standards imposed by international authorities. Software in use at CRS Clinical Data Management & Biometrics Department eCRF systemMedrio RDC (Remote Data Capture) Data handlingSAS (Statistical Analysis System);Pinnacle21 Explanation of abbreviations GAMP – Good Automated Manufacturing Practice – Supplier Guide for Validation of Automated Systems in Pharmaceutical ManufactureCDISC – Clinical Data Interchange Standards ConsortiumSDTM – Study Data Tabulation Model REACHING OUT IS EASY AND FAST – LET’S TALK Prof. Dr. Thomas Forst Chairman of the Executive Board LET’S TALK SCIENCE *protected email* +49 621 150 45 – 0 Martin Mulder Senior Vice President Corporate & Business Development LET’S TALK BUSINESS *protected email* +49 621 150 45 – 0 CRO Leadership Awards 2019 CRS is proud to be recognised again by pharma companies worldwide as a leading CRO with regard to: capabilities, compatibility, quality and reliability. European Biotechnology Guide Find CRS’s company profile in the European Biotechnology Science Industry Guide, volume 9 2019. EcoVadis – CSR Rating Based on the CSR rating by EcoVadis in 2022 CRS has been granted Silver Recognition Level.