Our monitoring specialists, trained by our company’s special education for monitors and possessed of a high level of expert knowledge, perform speedy and high quality services with flexibility to meet your needs.
We obtain highly reliable data that can sustain analysis. We provide drug allocation by various ways of allocation. Timely manage study progress.
We assure you that our thorough quality control, from data entry to logical checks to final data setup, will ensure high quality data.
We prepare various application documents and reports under strict quality control within shortest time. Our experienced staff, having wide range of expert knowledge in various therapeutic areas, proposes effective regulatory strategies.
Our experienced experts support collection, evaluation and analysis of safety information from clinical study, post-marketing clinical studies to post-marketing surveillance and support development of reports to MHLW.
GCP auditing operations are conducted as part of quality assurance activities in order to improve the reliability of a clinical study by evaluating and verifying, whether the clinical study is conducted in compliance with GCP(GPSP), the Pharmaceutical Affairs Law, the protocol, and the standard operating procedures, etc.
Our experienced staff respond to various needs for pharmaceutical development. Utilizing our network, we also support licensing plans from overseas and clinical development in Europe, the USA and Asia.
Utilizing abundant system development experience and accomplishments, we provide you with a clinical study IT solution in compliance with GCP, GPSP and related laws and regulations to improve the speed and quality of a clinical study.