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Cancer Terms
Cardiology
Cardio Vascular Terms
Case Report Form
Cell
CFR Code of Federal Regulations
Cheshire Labels
Chromosome
Clinical Research Associate (CRA)
Clinical Trials: Phases
Cloning
Community Health
Computed Radiography
CRO, Contract Research Organization
Cosmetic Surgery
Critical Care
CRM-Customer Relationship Mangement

Cancer Terms
Click below for a list of cancer terms from The National Cancer Institute
http://www.cancer.gov/dictionary/
Cardiology
The study of diagnosis and treatment of disorders of the heart and blood vessels
www.dcri.duke.edu/patient/glossary.jsp
Cardio Vascular Terms
Click below for a list of cardio vascular terms from The St. Jude Medical web site.
http://www.sjm.com/globals/glossary.aspx
Case Report Form
This describes the repository for all the protocol required information in a clinical trial to be reported to the sponsor of the clinical trial. It can be in written, optical or electronic document and may be referred to as a Case Record Form. See also Clinical Trials.

Product/Service Category: Clinical Services: Sub Category: Clinical Trial Mgmt Phase l
Suggested Reading:
Analysing Survival Data from Clinical Trials and Observational Studies
Clinical Trials : A  Methodologic Perspective
Suggested Trade and Journal Pubhlications:
Applied Clinical Trials,Drug Discovery & Development, Pharmaceutical Technology

Cell
A microscopic structure that is the primary organizational unit of all organisms and is capable of independent functioning. It is comprised of one or more nuclei, cytoplasm, organelles and inanimate matter. Every cell is encased within a semipermeable membrane. In plant cells the cell is further encased within a cell wall.

Product/Service Category: Genomics
Suggested Reading:
The Golden Helix : InsideBiotech Ventures
The Billion-Dollar Molecule :One Company's Quest for the Perfect Drug
From Genome to Therapy: Integrating New Techhnologies with Drug Development 
Clone : The Road to Dolly, and the Path Ahead
Suggested Trade/Journal Publications:
Biotechniques,Cell,Nature-Biotechnology

Genetics 101 
Tissue|Cell| Nucleus|Chromosome|DNA Strand|Gene|Nucleotides|Base Pair bp|Molecule|Atom

CFR 
The Code of Federal Regulations are the codified regulations borne of the laws of the United States Federal Government. Comprised of over fifty titles, Title 21 is entitled Food and Drugs, and prescribes the procedures to be followed by companies and individuals in the food and drug business. To access the actual code directly from the U.S. Government click here.

Product/Service Category: Legal Services, Contract Services Sub Category: Validation-Clinical
Suggested Reading:
FDA  Regulation of Medical Devices
Drug Biotechnology Regulation
Regulatory Practice for Biopharmaceutical Production
Suggested Trade and Journal Publications:
Applied Clinical Trials,Contract Pharma,  Pharmaceutical Executive,R & D Magazine


 
Cheshire Labels 
4 Up (4 Across) labels that are made of paper. When a mailer orders these they are generally provided at no charge. The mailer needs a special machine that separates and adheres these labels to their mail piece. Also, paper that has printed names and addresses which are to be mechanically affixed individually to each mailing piece. The types of paper include fanfold, accordion fold, etc.

 
Chromosome
One of a set of threadlike structures, composed of DNA and a protein, that form in the nucleus when the cell begins to divide and that carry the genes which determine a persons genetic heredity.  We have 23 pairs of chromosomes, each composed of DNA sub units whose sequence determines our entire array of genes.

Product/Service Category: Genomics
Suggested Reading:
Molecular Biotechnology 
From Genome to Therapy: Integrating New Techhnologies with Drug Development
Suggested Trade/Journal Publications:
Genetic Engineering News,Genomics

Genetics 101 
Tissue|Cell| Nucleus|Chromosome|DNA Strand|Gene|Nucleotides|Base Pair bp|Molecule|Atom

Clinical Research Associate (CRA)
Person employed by a sponsor, or by a contract research organization (CRO) acting on a sponsor's behalf, who monitors the progress of investigator sites participating in a clinical study. At some (primarily academic) sites, clinical research coordinators are called CRA's.
Source: Applied Clinical Trials/Advanstar. Click for their site: www.advanstar.com

Product/Service Category: Contract Services Sub Category:  Validation-Clinical
Suggested Reading:
Clinical Trials : A  Methodologic Perspective
Drug Biotechnology Regulation
Regulatory Practice for Biopharmaceutical Production
Suggested Trade and Journal Publications:
Applied Clinical Trials,Contract Pharma,  Pharmaceutical Executive,R & D Magazine

Clinical Trials: Phases
Clinical Trials are generally categorized into four (sometimes five) phases. An investigational medicine or product may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases.

Phase 1:
Initial safety trials on a new medicine in which investigators attempt to establish the dose range tolerated by about 20-30 healthy volunteers for single or multiple doses. Although usually conducted with healthy volunteers, Phase 1 trials are sometimes conducted with severely ill patients, for example those with cancer or AIDS. When pharmacokinetic issues are being addressed (for example, metabolism of a new antiepileptic medicine on stable epileptic patients whose microsomal liver enzymes have been induced by other antiepileptic medicines), trials may be conducted in less ill patients. Pharmacokinetic trials are usually considered Phase 1 trials regardless of when they are conducted during a medicine's development.

Phase 2a:
Pilot clinical trials to evaluate efficacy and safety in selected populations of about 100 to 300 patients who have the disease or condition to be treated, diagnosed or prevented. often involve hospitalized patients who can be closely monitored. Objectives may focus on dose-response, type of patient, frequency of dosing, or any of a number of other issues involved in safety and efficacy.

Phase 2b:
Well controlled trials to evaluate safety and efficacy in patients who have the disease or condition to be treated, diagnosed or prevented. These trials usually represent the most rigorous demonstration of a medicine's efficacy. Synonym: pivotal trials.

Phase 3:
Multicenter studies in populations of 1000 to 3000 patients (or more)
for whom the medicine is eventually intended. Phase 3 trials generate additional safety and efficacy data from relatively large numbers of patients in both controlled and uncontrolled designs and are used to support a PLA (Product License Application). Trials are also conducted in special groups of patients or under special conditions dictated by the nature of the particular medicine and/or disease. Phase 3 trials are often provide much of the information needed for package insert and labeling of the medicine.

Phase 3b:
Trials are conducted after submission of a new drug application (NDA), but before the product's approval for market launch. Phase 3b trials may supplement or complete earlier trials, or they may seek different kinds of information (for example, quality of life or marketing). Phase 3b is the period between submission for approval and receipt of marketing authorization.

Phase 4
After a medicine is marketed, Phase 4 trials provide additional details about the product's safety and efficacy. They may be used to evaluate formulations, dosages, durations of treatment, medicine interactions, and other factors. Patients from various demographic groups may be studied. An important part of many Phase 4 studies is detecting and defining previously unknown or inadequately quantified adverse reactions and related risk factors. Phase 4 studies that are primarily observational or non experimental are frequently called post marketing surveillance.

Phase 5:
Post marketing surveillance is sometimes referred to as Phase 5.

Source: Applied Clinical Trials/Advanstar. Click for their site: www.advanstar.com

Product/Service Category: Clinical Services, Contract Services Sub Category: Clinical Trial Mgmt Phase l,  Validation-Clinical
Suggested Reading:
Analysing Survival Data from Clinical Trials and Observational Studies
Clinical Trials : A  Methodologic Perspective
Improving R & D Performance the Juran Way
Suggested Trade and Journal Publications:
Applied Clinical Trials,Contract Pharma,  Pharmaceutical Executive,R & D Magazine

Cloning
The process of producing, exact copies of a single gene, other DNA segments, an entire cell or a complete organism. Cloned collections of DNA  are called clone libraries and are useful tools in helping scientists piece together our genetic information.

Product/Service Category: Genomics
Suggested Reading:
From Genome to Therapy: Integrating New Techhnologies with Drug Development
Automation Technologies for Genome Characterization
Suggested Trade/Journal Publications:
Genetic Engineering News,Genomics

Community Health
Or public health is an aspect of health services concerned with threats to the overall health of a community based on population health analysis.
www.dictionaryofeverything.com/explore/957/Medicine.html
Computed Radiography (CR)
Is a technology that Fujifilm pioneered and began marketing in the early1980s, is a system that brings the power of computers to image acquisition, processing, display and management. 
     Advantages of CR
       Virtual elimination of the need for re-takes.
       Elimination of lost images.
       Simplification in the filing of images.
       Increased capability for consultation made
       possible by electronic transmission of digital
       images.

Source: Fujifilm Medical Imaging. Click for their site: www.fujimed.com/medical/medical.html

Product/Service Category: Instrumentation : Sub Category: Microscopy & Image Analysis
Suggested Reading:
Bioprocess Engineering : Systems, Equipment and Facilities
Maintenance and Repair of Laboratory, Diagnostic Imaging and Hospital Equipment
Suggested Trade and Journal Publications:
American Biotechnology Laboratory,  Biomedical Products,Laboratory Equipment

CRO, Contract Research Organization
This term applies to a type of organization that offers their clients a wide range of pharmaceutical research services. These services include; product development and formulation, clinical trial management-preclinical through phase IV, central  laboratory services for processing trial samples, data management services for preparation of an FDA New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA), and many other complementary services. The primary benefit CROs offer their clients is the experience of moving a new drug from its conception to FDA marketing approval. 

Product/Service Category: Clinical Services, Contract Services Sub Category: Clinical Trial Mgmt Phase l,
Suggested Reading:
Clinical Trials : A  Methodologic Perspective
Improving R & D Performance the Juran Way
Suggested Trade and Journal Publications:
Applied Clinical Trials,Contract Pharma,  Pharmaceutical Executive,R & D Magazine

Cosmetic Surgery
The term "Cosmetic Surgery" means medically unnecessary surgical procedures, usually, but not limited to, plastic surgery directed toward preserving beauty.
www.wwcta.org/ins7-def.htm
Critical Care
Critical healthcare provided to a critically ill patient during a medical emergency or crisis.
www.hc-sc.gc.ca/english/organandtissue/glossary/
Customer Relationship Management (CRM)

Customer Relationship Management, which places the customer's needs first, involves two different steps: first, deeply understanding your customers, and secondly, aligning the organization's capabilities in order to better deliver value to customers. (Andersen Consulting, Mr. Dale Renner).

Customer Relationship Management is the ability to treat different customers differently. The focus of the 1:1 enterprise is not to find more customers for it's products, but to find more products for it's customers, CRM with a customer is not a reward for past transactions, but an investment in the future, (Peppers and Rogers Group). 

Customer Relationship Management, is the integration and alignment of processes, culture and systems to deliver an organization's most valuable customers, (White Whale Limited).

Product/Service Category: Marketing, Media & CRM
Suggested Reading: CRM Conference Summary-Phila 3/28-3/30/2001
Successful Pharmaceutical Selling 
Drugs to Market : Creating Value and Advantage in the Pharmaceutical Industry 
Pharmaceutical Marketing in the 21st Century
Pharmaceutical Marketing : Strategy and Cases

From The CRM Forum


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