Japan Agency for Medical Research and Development
Authorized Generic Authorized generics are prescription drugs produced by brand pharmaceutical companies and marketed under a private label, at generic prices.
Chemistry, Manufacturing, and Controls
Contract Development Manufacturing Organization. CMIC provide services primarily to pharmaceutical companies to support drug formula development and manufacturing.
Contract Medical Representative
Clinical Research Associate The person in a clinical trial who is overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement.
Clinical Research Coordinator CRC help doctors improve the quality of clinical trial and minimize their burdens attributed to trials.
Contract Research Organization CMIC provide services primarily to pharmaceutical companies to support drug development.
Contract Sales Organization CMIC provide sales- and marketing-support services, primarily to pharmaceutical companies.
Evidence-Based Medicine Health care whose policies and practices are derived from the systematic, scientific study of the effectiveness of various treatments.
Electronic Data Capture
Food and Drug Administration
Good Clinical Practice A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Good Manufacturing Practice A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Good Post-marketing Study Practice
Good Quality Practice
Good Vigilance Practice
Health Technology Assessment
Informed Consent A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.
In Country Clinical Care-taker ICCC is defined as has a responsibility on behalf of the Sponsor who has bee established outside Japan and no affiliated company in Japan, to assure taking necessary steps against occurrence and/or outbreak of health hazard caused by study drugs, as “”Sponsor”” that is defined in Pharmaceutical Affairs Law and GCP.
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use
Innovative Pharma Model CMIC’s IPM business is providing new business solutions to pharmaceutical companies that combine marketing authorization licensing and value chains.
Institutional Review Board An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
Marketing Approval Holder
The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement.
Medical Science Liaison
Over The Counter A medicine that can be bought without a prescription (doctor’s order).
Medicine for Rare Diseases stated in Pharmaceutical and Medical Device Act Article 77 (2). A medicinal drug which is effective in the treatment of some diseases, but which is not manufactured or marketed because the demand is insufficient to cover the costs of supply.
Pharmacogenomics The study of how a person’s genes affect the way he or she responds to drugs. pharmacogenomics is being used to learn ahead of time what the best drug or the best dose of a drug will be for a person. also called pharmacogenetics.
Pharmacovigilance The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.
Personal Health Record A collection of information about a person’s health. it may include information about allergies, illnesses and surgeries, and dates and results of physical exams, tests, screenings, and immunizations.
Pharmaceuticals and Medical Devices Agency
Post Marketing Surveillance PMS is a survey to assure the quality, efficacy and safety of drugs etc. after they go on the market.
A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.
Pharmaceutical Value Creator PVC is CMIC’s unique business model contributing to increase additional values of pharmaceutical companies.
Quality Assurance All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).
Quality Control The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.
Quality of Life The overall enjoyment of life.
Risk Based Monitoring
Risk Management Plan
Real World Data
Source Data(document) Verification The process of comparing CRF entries with source documents to ensure CRF entries are complete, accurate, and consistent with source data.
Site Management Organization SMO is a term that refers to an agency which supports clinical trials for pharmaceutical product development. It plays a role of a coordinator in clinical trials, supporting administrative management and practical execution in full compliance with GCP.