Glossary

ABCD

AMED

Japan Agency for Medical Research and Development

AG

Authorized Generic
Authorized generics are prescription drugs produced by brand pharmaceutical companies and marketed under a private label, at generic prices. 

CMC

Chemistry, Manufacturing, and Controls

CDMO 

Contract Development Manufacturing Organization.
CMIC provide services primarily to pharmaceutical companies to support drug formula development and manufacturing.

CMR

Contract Medical Representative

CRA 

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.

CRC

Clinical Research Coordinator
CRC help doctors improve the quality of clinical trial and minimize their burdens attributed to trials.

CRO

Contract Research Organization
CMIC provide services primarily to pharmaceutical companies to support drug development.

CSO

Contract Sales Organization
CMIC provide sales- and marketing-support services, primarily to pharmaceutical companies. 

EFGH

EBM

Evidence-Based Medicine
Health care whose policies and practices are derived from the systematic, scientific study of the effectiveness of various treatments.

EDC

Electronic Data Capture

FDA

Food and Drug Administration

GCP

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.

GMP

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.

GPSP

Good Post-marketing Study Practice

GQP

Good Quality Practice

GVP

Good Vigilance Practice

HTA

Health Technology Assessment

IJKL

IC

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.

ICCC

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.

ICH 

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use

IPM

Innovative Pharma Model
CMIC's IPM business is providing new business solutions to pharmaceutical companies that combine marketing authorization licensing and value chains.

IRB

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. 
 

MNOP

MA

Medical Affairs

MAH

Marketing Approval Holder

MD

Medical Doctor

Monitoring

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.

MSL

Medical Science Liaison

MR

Medical Representative

OTC

Over The Counter
A​​​ medicine that can be bought without a prescription (doctor's order).

Orphan Drug

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.

PGx

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.

PV

Pharmacovigilance
The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.

PHR

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.

PMDA

Pharmaceuticals and Medical Devices Agency

PMS

Post Marketing Surveillance
PMS is a survey to assure the quality, efficacy and safety of drugs etc. after they go on the market.

Protocol

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.

PVC

Pharmaceutical Value Creator
PVC is CMIC's unique business model contributing to increase additional values of pharmaceutical companies.

QRST

QA

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). 

QC

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. 

QOL

Quality of Life
The overall enjoyment of life.

RBM

Risk Based Monitoring

RMP

Risk Management Plan

RWD

Real World Data

SDV

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.

SMO

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.
 

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