Career in Clinical Research Seminar by Bilcare Research Academy
Dates and Time
-----------------------
> 1 Dec, 2007 12 pm to 1 pm
> 2 Dec, 2007 12 pm to 1 pm
> 3 Dec to 7 Dec, 2007 4 pm to 5 pm, 6pm to 7pm
Venue : Bilcare Research Academy
Bangalore Diabities Hospital,
16/M Thimmaiah Road,
Vasan Nagar, Bangalore-52
Saturday, December 1, 2007
Sunday, November 18, 2007
Free Clinical Research Books available Online
| To Learn Basics Of Clinical Research on your own. Check - “Harvard-MIT Lecture Series : Learn Basic Clinical Research on you own” |
| If you are looking for Clinical Research Jobs Check - Here |
| 60+ Clinical Research Companies Check – Here, The information could serve handy in finding jobs and other information about the Companies |
| Free Clinical Research Books available Online Check - Here |
Clinical Research: What It Is and How It Works by Lori A. Nesbitt
Principles and Practice of Clinical Research by John I Gallin
Designing Clinical Research by Stephen B. Hulley
Physician Investigator Handbook: Gcp Tools and Techniques by Deborah Rosenbaum
Ethics and Regulation of Clinical Research
Clinical Research: Concepts and Principles for Advanced Practice Nurses
Sample Size Calculations in Clinical Research by Shein-Chung Chow, Jun Shao, Hansheng Wang
Clinical Research in Pharmaceutical Development by Barry Bleidt, Michael Montagne
The Clinical Research Process in the Pharmaceutical Industry by Gary M. Matoren
Allogeneic Stem Cell Transplantation: Clinical Research and Practice
HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP)
Saturday, November 17, 2007
Clinical Research Opportunities
> For MBBS, BHMS, BAMS Doctors, Phrma and other Medical Graduates
Principal Investigator
Co-investigator
Medical Advisor
Drug Developers
Regulatory Affairs Manager
Clinical Research Physician
Medical Writers
Clinical Research Associates
Site Co-ordinators
Clinical Research Managers
Drug Development Associates
> For Management Professionals
Business Development
Clinical Project Management
Clinical Research Management
Regulatory Affairs Management
Principal Investigator
Co-investigator
Medical Advisor
Drug Developers
Regulatory Affairs Manager
Clinical Research Physician
Medical Writers
Clinical Research Associates
Site Co-ordinators
Clinical Research Managers
Drug Development Associates
> For Management Professionals
Business Development
Clinical Project Management
Clinical Research Management
Regulatory Affairs Management
Clinical Research Books to Buy
Clinical Research – What it is and How it Works Author Lori A. Nesbitt
Link : Read
Conducting Clinical Research, Author Judy Stone, M. D.
Link : Read
Fundamentals of Clinical Trials, Author Laurence M. Friedman, Kurt D. Furberg and David L. DeMets
Link : Read
Becoming a successful Clinical Research Investigator, Author David Ginsberg
Link : Read
A CRAs guide to Monitoring Clinical Research, Author Karen E. Woodin and John C. Schneider
Link : Read
A guide to patient recruitment and retention, Author Diana L. Anderson
Link : Read
Clinical Trials Design, Author Stark NJ
Link : Read
CRA Hanbook, Author Stark NJ
Link : Read
Investigator's Guide to Clinical Research, Author Stark NJ
Link : Read
Project Management for Clinical Trials, Author Stark NJ
Link : Read
Other Books
Ethics of the use of human subjects in research, Author Adil E. Shamoo and Felix A. Khin-Maung-Gyi
Responsible Research- A guide for Coordinators, Author Carol A. Fedor, Philip A. Cola and Christine Pierre
Biomedical Ethics, Author Walter Glannon
Protecting study volunteers in Research, Author Cynthia M. Dunn and Garry L. Chadwick
Fundamentals of Clinical Research, Author Antonella Bacchieri and Giovanni D. Cioppa
Link : Read
Conducting Clinical Research, Author Judy Stone, M. D.
Link : Read
Fundamentals of Clinical Trials, Author Laurence M. Friedman, Kurt D. Furberg and David L. DeMets
Link : Read
Becoming a successful Clinical Research Investigator, Author David Ginsberg
Link : Read
A CRAs guide to Monitoring Clinical Research, Author Karen E. Woodin and John C. Schneider
Link : Read
A guide to patient recruitment and retention, Author Diana L. Anderson
Link : Read
Clinical Trials Design, Author Stark NJ
Link : Read
CRA Hanbook, Author Stark NJ
Link : Read
Investigator's Guide to Clinical Research, Author Stark NJ
Link : Read
Project Management for Clinical Trials, Author Stark NJ
Link : Read
Other Books
Ethics of the use of human subjects in research, Author Adil E. Shamoo and Felix A. Khin-Maung-Gyi
Responsible Research- A guide for Coordinators, Author Carol A. Fedor, Philip A. Cola and Christine Pierre
Biomedical Ethics, Author Walter Glannon
Protecting study volunteers in Research, Author Cynthia M. Dunn and Garry L. Chadwick
Fundamentals of Clinical Research, Author Antonella Bacchieri and Giovanni D. Cioppa
Basic Clinical Research Tutorial
What is Clinical Research?
Clinical Research is systematic study of new drugs, devices, biological products and vaccines intended for diagnosis, prevention or treatment of diseases. The aim of the study is to improve healthcare in the society by making safe and effective drugs available at low cost.
The new drug development process involves drug discovery, animal experiments followed by studies conducted on human beings to assess the therapeutic effectiveness and toxicity by way of well designed experiments known as clinical trials. The word clinical refers to human beings. Clinical trials are conducted in three phases with increasing participation of human subjects at each subsequent stage. Clinical trials ensure safety and help to prove therapeutic efficacy of the new drug before the drug is available for prescription. Since drug trials involve human subjects, these are governed by scientific, medical, ethical, and legal guidelines to impart maximum safety and benefits to human subjects participating in the trials.
What are Clinical Trials?
Clinical Trials are studies conducted on human subjects for verifying the clinical, pharmacological and adverse effects of the drug. These are clearly defined and well designed studies to meet the objective of determining safety and efficacy of the new drug. They are generally comparative studies conducted in a randomized double blind fashion. The subjects participating in the study are duly informed about the risks and benefits involved in the study and a written voluntary consent is obtained. A protocol is prepared describing the details of the various steps and procedures to be followed which must be duly approved by an independent Ethics Committee. The data generated is submitted to the regulatory authority with New Drug Application for registration and marketing approval.
Why Clinical Research?
Clinical research helps to bring new drugs into the market for new diseases, or introduce drugs with lesser side effects, drugs having low cost, better compliance, and lower undesirable drug interactions. They may be conducted to study delayed and long term adverse effects of the drugs meant for chronic ailments. All new vaccines, Diagnostic products, medical devices, biological and biotechnology products are considered as new drugs and have to undergo similar testing before marketing.
Why are Clinical Trials important?
Animal data help to predict the biological effects and toxicity of a new drug but cannot be directly extrapolated to humans due to species differences. The only way to know the actual effects of a drug in human beings is through human experiments or trials. Well designed trials conducted based on sound scientific principles and standards (Good Clinical Practice) generate good quality data for interpretation and regulatory approval.
What are phases of Clinical Trials?
These are the stages of drug developments with increasing information on human safety and effectiveness. There are four phases of trials and the results of one phase help to plan the next. Conducting trials in phases helps to minimize risk by exposing limited number of subjects at each stage and generate sufficient data for further studies. Of these phases three are conducted for regulatory approval of the drug or device and the fourth phase is conducted after marketing.
Pre regulatory clinical trials are been divided into 3 Phases:
Phase I: These are also known as Human Pharmacology. This is the most crucial phase since the new drug is given for the first time to a small group of healthy human volunteers under close medical supervision to assess the tolerability and toxicity at selected doses. The pharmacokinetic and pharmacodynamic parameters are studied to establish the safety of the new drug in human being. This study may be done with increasing doses or repeating single doses.
Phase II: These are known as Exploratory Trials. After the drug has been proved safe in phase I, it is tested on few hundred patients to assess the therapeutic effectiveness and safety. Both improvement in disease symptoms and adverse effects are observed and recorded on structured sheets called Case Report Form.
Phase III: These are also known as Confirmatory Trials. The studies are conducted in a larger number of patients and the efficacy and safety of the new drug is compared with a standard drug based on predefined criterion. This phase is conducted at multiple sites and includes few thousand patients who resemble end users. Majority of the time and money spent on clinical development is in this phase.
Disclaimer : The above data is taken from website http://www.bilcareacademy.com/faq.htm
Clinical Research is systematic study of new drugs, devices, biological products and vaccines intended for diagnosis, prevention or treatment of diseases. The aim of the study is to improve healthcare in the society by making safe and effective drugs available at low cost.
The new drug development process involves drug discovery, animal experiments followed by studies conducted on human beings to assess the therapeutic effectiveness and toxicity by way of well designed experiments known as clinical trials. The word clinical refers to human beings. Clinical trials are conducted in three phases with increasing participation of human subjects at each subsequent stage. Clinical trials ensure safety and help to prove therapeutic efficacy of the new drug before the drug is available for prescription. Since drug trials involve human subjects, these are governed by scientific, medical, ethical, and legal guidelines to impart maximum safety and benefits to human subjects participating in the trials.
What are Clinical Trials?
Clinical Trials are studies conducted on human subjects for verifying the clinical, pharmacological and adverse effects of the drug. These are clearly defined and well designed studies to meet the objective of determining safety and efficacy of the new drug. They are generally comparative studies conducted in a randomized double blind fashion. The subjects participating in the study are duly informed about the risks and benefits involved in the study and a written voluntary consent is obtained. A protocol is prepared describing the details of the various steps and procedures to be followed which must be duly approved by an independent Ethics Committee. The data generated is submitted to the regulatory authority with New Drug Application for registration and marketing approval.
Why Clinical Research?
Clinical research helps to bring new drugs into the market for new diseases, or introduce drugs with lesser side effects, drugs having low cost, better compliance, and lower undesirable drug interactions. They may be conducted to study delayed and long term adverse effects of the drugs meant for chronic ailments. All new vaccines, Diagnostic products, medical devices, biological and biotechnology products are considered as new drugs and have to undergo similar testing before marketing.
Why are Clinical Trials important?
Animal data help to predict the biological effects and toxicity of a new drug but cannot be directly extrapolated to humans due to species differences. The only way to know the actual effects of a drug in human beings is through human experiments or trials. Well designed trials conducted based on sound scientific principles and standards (Good Clinical Practice) generate good quality data for interpretation and regulatory approval.
What are phases of Clinical Trials?
These are the stages of drug developments with increasing information on human safety and effectiveness. There are four phases of trials and the results of one phase help to plan the next. Conducting trials in phases helps to minimize risk by exposing limited number of subjects at each stage and generate sufficient data for further studies. Of these phases three are conducted for regulatory approval of the drug or device and the fourth phase is conducted after marketing.
Pre regulatory clinical trials are been divided into 3 Phases:
Phase I: These are also known as Human Pharmacology. This is the most crucial phase since the new drug is given for the first time to a small group of healthy human volunteers under close medical supervision to assess the tolerability and toxicity at selected doses. The pharmacokinetic and pharmacodynamic parameters are studied to establish the safety of the new drug in human being. This study may be done with increasing doses or repeating single doses.
Phase II: These are known as Exploratory Trials. After the drug has been proved safe in phase I, it is tested on few hundred patients to assess the therapeutic effectiveness and safety. Both improvement in disease symptoms and adverse effects are observed and recorded on structured sheets called Case Report Form.
Phase III: These are also known as Confirmatory Trials. The studies are conducted in a larger number of patients and the efficacy and safety of the new drug is compared with a standard drug based on predefined criterion. This phase is conducted at multiple sites and includes few thousand patients who resemble end users. Majority of the time and money spent on clinical development is in this phase.
Disclaimer : The above data is taken from website http://www.bilcareacademy.com/faq.htm
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