PRINEOS

PRINEOS is both a CRO and strategic consulting company whose goal is to improve and innovate clinical research in the healthcare industry. We provide services on: • Biostatistics & Data Management (study design, sample size calculation, advanced statistical methodology, data collection strategy, eCRF, Data Entry, Coding, Plan and Report, trainings, etc.) • Medical Affairs (identification of medical needs and data gaps, study concept sheet development, medical writing, trainings, management of KOLs, Steering Committees, Advisory Board, etc.) • Clinical Operations (project management, site/country feasibility, management of enrolment/retention, study documentation management, monitoring, vendor oversight, etc.) • Legal Affairs (regulatory strategy and support, Clinical Trial Agreements’ management, legal and privacy consultancy services, trainings, etc.) • Quality Management (QMS plan, report, gap analysis, audits, trainings, certifications, etc.) Moreover, our Regulatory Unit assists Medical Devices manufacturers in the transition towards MDR, including services such as Technical Documentation drafting & review, CEP/CER, Risk Analysis, PMS/PMFC, SSCP, BEP/BER and ADME test, MDSAP and interface with Notified Bodies. To learn more, visit www.prineos.com