GLOSSARY

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C

Term Definition
CAB (Conformity Assessment Body)

The body that determines compliance to ISO 13485.

CAC (Carrier Advisory Committees)

The committee that performs a review of all local coverage decisions through Medicare.

CAF (contracting administration fee)

The fee that a Global Purchasing Organization will charge for managing the purchasing contracts for many end users, paid by the manufacturer.

CAGR (compound annual growth rate)

The annual growth rate for an investment.

CAPA (Corrective and Preventive Actions)

Corrective and Preventive Actions; One subsystem of a Quality Management system; the system to implement corrections upon and to avoid future problems in quality control.

Capability-based advantages

A company's advantage over competitors that is driven by a company’s capabilities. They are based on the ability to do something better or less expensively than the competition and/or customers.

Case controlled study

A study that compares outcomes of a group of patients treated with a new device or procedure to a matched group receiving no treatment (or a standard treatment).

Cash flow Statement

An accounting statement that shows the cash that flows in the company in each period (typically quarter) minus the cash that flows out in the same period.

CBER (Center for Biologics Evaluation &

Center for Biologics Evaluation & Research; the part of the FDA that approves biologics.

CDER (Center for Drug Evaluation & Resea

Center for Drug Evaluation & Research; the part of the FDA that approves drugs.

CDRH (Center for Device and Radiological

Center for Device and Radiological Health; The center within the FDA (Food & Drug Administration) responsible for medical device regulation.

CE Mark

Resulting 'mark' that is given to a device in the EU to indicate regulatory approval.

Citation

A formal warning to a company from the FDA; prosecution will follow if changes are not made.

Civil Penalties

Monetary penalties imposed on a company after a hearing for violations.

Class I

Classification of a medical device by FDA that indicates low risk to a person.

Class II

Classification of a medical device by FDA that indicates intermediate risk to a person; devices are more complicated than Class I but non-invasive.

Class III

Classification of a medical device by FDA that indicates highest risk to a person; devices are typically invasive or life sustaining.

Clinical investigator

A medical researcher in charge of carrying out a clinical trial's protocol.

Clinical Study Protocol

A study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.

Clinical Trial

A research study performed to answer specific questions about diagnoses or therapies, including devices, or new ways of using known treatments. Clinical trials are used to determine whether new treatments are both safe and effective.

CME (Continuing Medical Education)

Additional training required to maintain a license for physicians and others in healthcare-related fields.

CMS (Centers for Medicare and Medicaid S

The primary government payer of health care charges for the elderly and disabled in the US.

Coding

The process of assigning a specific, identifiable code to a medical procedure or process.

COGS (cost of goods sold)

Raw materials costs for a product.

Common stock

Equity in a company that confers on shareholders voting and pre-emptive rights (the right to keep a proportionate ownership of the company by buying additional shares when new stock is issued).

Comparables analysis

Evaluating the pricing strategies (and associated reimbursement status) of similar offerings in the field.

Competitive benchmarks

Benchmarks and comparable data related to the type of business model the company has chosen and the sector/industry within which the company operates.

Conditions precedent

Section of a term sheet that outlines what steps must be taken before the financing deal proposed in the term sheet can be finalized.

Controlled trial

A trial that uses two groups: one that receives treatment, and a second, control group, that does not, in order to compare outcomes.

Conversion, Automatic conversion

Section of a term sheet that that describes how preferred shares will convert to common shares.

Convertible bonds

A hybrid debt-equity alternative to companies seeking financing. A type of bond that can be converted into shares of stock of the issuing company, usually at some pre-announced ratio.

Core laboratory

Laboratories that analyze data from a clinical trial; these laboratories often have specialized equipment and expertise.

Corporate investment

When Corporations invest in new companies by (1) the purchase of equity in support of a research and development or a licensing agreement, or (2) traditional venture investments.

Correction

Repair or modification of a distributed product while it is still under the control of the manufacturer.

Cost-effectiveness model

A model for determining product value where cost is expressed per unit of meaningful efficacy, usually used comparatively across interventions.

Cost-utility analysis

A model for determining product value where cost is assigned for quality of life and years lived. It is based on clinical outcomes measures related to quality of life and/or disability and mortality.

Cost/benefit analysis

A model for determining product value that demonstrates that the money spent on the device is lower than the total cost of the outcomes of the disease or of current standard therapy.

CPT (Common Procedural Terminology) code

Codes used to classify medical procedures in a standard way so that the same procedure is reimbursed in the same way across all facilities. Also known as HCPCS Level 1 codes.

CRO (Contract Research Organization)

Contract (or Clinical) Research Organization; an independent organization that provides management services for clinical trials.

Cycle of care

A description of how a patient interacts with the medical system.

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