Support for Clinical development
Clinical development planning（pharmaceuticals）
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.
Clinical development planning（medical devices）
MIC have accumulated a wealth of knowledge and experience in approval application of new medical devices such as disposable, implants, electrical medical devices, dental materials since its inauguration of 20 years ago. We can provide comprehensive regulatory support based on experiences and specialties such as chemistry, pharmacology, biology, medicine, and electrical engineering.
Monitoring（pharmaceuticals / medical devices）
Monitoring activities cover clinical trial application to PMDA and contracts with the investigational sites in addition to monitoring the actual clinical trial. MIC Medical’s Monitors are highly trained professionals with expertise in clinical trial monitoring. Monitors carefully check compliance with Good Clinical Practice (GCP), Japan’s Pharmaceutical Affairs Law (PAL), Protocol and Standard Operating Procedures (SOP), proper documentation and reporting, and ensuring subjects human rights and safety.
QC（pharmaceuticals / medical devices）
Our Quality Control (QC) program ensures the quality of the Clinical Trial by verifying that the pharmaceutical, medical device or post-marketing trial(including any investigator initiated clinical trial) is performed in compliance with the applicable law and/or regulation at the time such as Japan’s Pharmaceutical Affairs Law (PAL), GCP, Trial Protocol, and Standard Operating Procedures(SOP).
GCP Audit（pharmaceuticals / medical devices）
We evaluate each clinical trial impartially and independently from our routine monitoring and quality control activities. GCP Audit include compliance with the study protocol, SOPs, GCP, and all applicable regulatory requirements. We provide GCP auditing for pharmaceuticals, medical devices, investigator initiated clinical trials, and post-manufacturing clinical trials adhering to Good Post-marketing Study Practice(GPSP).
In order to perform the functions of a professional CRA/CRC, client staff need an in-depth knowledge of Clinical Study management, rules regarding the Pharmaceutical and Medical Device Act, Good Clinical Practices (GCP), and a basic knowledge of medical and pharmaceutical sciences. Computer and good communication skills are also required. MIC Medical invests significant resources in the training support for client staff. We offer superior instructors and employ exceptional training methods to provide client staff the pertinent knowledge and skills needed to perform the functions of a highly skilled and efficient CRA/CRC.
Regulatory Affairs /Medical Writing（pharmaceuticals / medical devices）
MIC employs regulatory experts with long-term experience in Drug and Medical Device Manufacturing. We provide complete support, from the preparation of the clinical study report to obtaining Japan Marketing approval.
Sending Clinical Research Specialists（pharmaceuticals / medical devices）
MIC provides experienced and highly trained staff to advance the clinical trial to successful completion. Our medical license holders which include pharmacists, Medical Representatives (MRs) and nurses are extremely skilled and reliable providing long-term service and support at the clinical sites.
Contracted study number（Pharmaceuticals / Medical devices）
MIC’s Scope of Service includes Monitoring, QC, QA, Medical Writing (SOPs, Investigational Device Brochures, Protocol, Case Report Forms (CRFs), Informed Consent, Clinical Study Reports), Safety Review Committee establishment (SAE committee) and coordinating with IRB.Contracted study number