Types of research and regulatory aspects

CRO – what documents can it prepare for a clinical trial? Differences between primary and secondary studies in research practice CTIS and RFIs without stress – how to effectively manage communication with regulators? Where and how to register clinical trials, medical device studies, and observational studies? How long does it take to prepare the full documentation required for a CTIS submission? How long does it usually take to obtain approval for a clinical trial application in CTIS? What are the requirements for personal data protection (RODO/GDPR) in clinical and observational studies? What are the differences in formal requirements between clinical trials and observational studies? How to Submit a Clinical Trial Application in CTIS? Can a CRO assist in preparing and submitting a clinical trial application in the CTIS system? I’m not sure whether my project qualifies as a clinical trial, a medical experiment, or an observational study. Are approvals from the Bioethics Committee and URPL always required? Do you assist with product or device registration? Can a CRO help prepare documentation for the Bioethics Committee? Does the company have experience with medical device studies under MDR?