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Clinical development planning

Upon the request of pharmaceutical companies for clinical development, MIC plans phase 1 to bridging clinical trials, based on our enriched experience with practical clinical development. Specifically for foreign manufacturers, we give support to develop new pharmaceuticals as an In-Country Clinical Trial Caretaker. MIC's services cover entire process of clinical development such as consultation with the Pharmaceuticals and Medical Devices Agency (PMDA) which is essential at early stage of clinical development in addition to preparation of Investigator's Brochure, Protocol, Case Report Form (CRF) and Informed Consent (IC) form, selection of investigational sites for a clinical trial, and approval application to PMDA.

Steps towards approval application of pharmaceuticals
Development of pharmaceuticals starts with discovery of a useful chemical compound. Once a compound is determined for further evaluation based on production tests and animal tests, a clinical trial involving human subjects is initiated. At the first clinical trial, safety and pharmacokinetics are studied on healthy subjects (usually male adults), followed by a small-scale clinical trial on a small group of patients as well as testing for determination of usage and dosage. Then, a large-scale investigational study is performed, which may include a long-term use test. Approval application is submitted by compiling results from those studies.
If PMDA will have been satisfactory to those study results, approval order for marketing will be issued.