InClino | InClino

InClino CRO is a fullservice European contract research organization with 20 years of experience in clinical research and regulatory affairs. We help therapies to work wonders. We support pharmaceutical, biotech, medical device and digital health companies from development through clinical studies, market access and post-market activities, with operational coverage across Europe. Pharmaceutical Services: Clinical trials Phase I–IV, bridging and observational studies, from protocol to final report Feasibility, site selection, start-up, monitoring and project management Regulatory strategy and EU submissions Pharmacovigilance and safety reporting Data management and biostatistics European regulatory representation and post-authorisation monitoring Medica Devices (MDR/IVDR) Clinical investigations and post-market clinical follow-up Clinical evaluation CE marking strategy and technical documentation Quality management systems and risk management Authorized Representative and EUDAMED registration Postmarket surveillance and Health Technology Assessment Digital health and mHealth Regulatory strategy and pathway for software Trials, documentation and health technology assessment We work with international sponsors entering the market and with companies scaling to multi center studies, providing fast access to high recruiting patient populations, experienced sites and local regulatory knowledge.