by Waltteri Sorvisto | Mar 27, 2025 | CRO
Building a Compliant Clinical Investigation from the Ground Up Before a clinical investigation can begin, several critical elements must be in place to ensure regulatory compliance, data quality, and patient safety. Under MDR (EU 2017/745) and ISO 14155, the processes...
by Waltteri Sorvisto | Mar 20, 2025 | CRO
The Role of Documentation in MDR-Compliant Clinical Investigations Proper documentation is the backbone of every clinical investigation. Under MDR (EU 2017/745) and ISO 14155, medical device manufacturers are required to maintain a comprehensive set of documents to...
by Waltteri Sorvisto | Mar 13, 2025 | CRO
The Importance of Clinical Investigation Planning Under MDR When preparing to bring a medical device to market under MDR (EU 2017/745), one of the most critical steps is the planning of your clinical investigation. Regulatory authorities require manufacturers to...
by adminReaktio | Nov 7, 2024 | CRO
Key Aspects of Our Clinical Trial Auditing Services Clinical Trial Auditing We conduct thorough audits of clinical trials to assess compliance with study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. Our auditing covers all stages of...
by adminReaktio | Nov 7, 2024 | CRO
KEY ASPECTS OF OUR GLP STUDY SERVICES Compliance with GLP Standards We ensure that all aspects of our GLP studies adhere to international Good Laboratory Practices, including proper study planning, execution, monitoring, recording, archiving, and reporting. Study...
by adminReaktio | Nov 7, 2024 | CRO
Key Aspects of Our CRA and Monitoring Services Research Protocol Development Our CRA team is actively involved in developing comprehensive research protocols that outline objectives, design, methodology, statistical considerations, and the overall structure of a...
