Support for clinical trialsClinical trials must be designed to achieve their goal as well as to prove the safety and efficacy of the product for patients. In any data submitted to the Japanese authorities, it is essential to consider the medical situation and environment in Japan. As an example, does a comparative device (or drug) have approval for the same purpose in Japan? Are there any concerns regarding differences in the physiological make-up of diverse races? Does the study comply with Japanese GCP requirements?
Our experienced consultants can provide support to design clinical studies that consider these issues, prepare the necessary documents, and initiate/manage the study while maintaining closed communication with its clients and with the authority.
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Study design/protocol design |
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Pre-clinical trial meeting with PMDA (the Pharmaceutical and Medical Device Agency) |
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Site evaluation |
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Study initiation |
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Study management and coordination |
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Database management and quality control |
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Interim reporting |
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Final reporting |
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