In order to ensure the reliability, we comply with "Ethical Guidelines for Medicine research involving human subjects" and “GCP” and support for clinical research by providing services such as monitoring and auditing.
Based on our experience in each specialized field of drug/medical device development, we propose an optimal monitoring plan which responds to the nature of each clinical research, by which we will improve the quality of monitoring tasks as well as improving efficiency.
・Project Management for clinical research
・Monitoring for clinical research
・Audit for clinical research for clinical research
・Prepare Case Report Form
・Prepare documents regarding clinical research
・ICCC/Regulatory Affairs consultation
・Support for medical institutions