Clinical Trials Research and Administration (12 Months)

Overview

Traditional medical practice entails a doctor prescribing for a patient that treatment which in his judgment, based on past experience of himself and others, offers the best prognosis. Since there are few conditions for which treatment is 100% effective, there is much scope for potential improvements in therapy and such improvements are derived via clinical trials. Clinical trial is a new emerging field in the area of pharmaceutical sciences or medical sciences. Clinical trials are research studies that test the effects of "health interventions" on people. Such health interventions are most commonly new drugs or treatments, though clinical trials may also examine the effects of other health interventions such as diagnostic methods, surgeries, technological devices, and educational methods.

Aims & Objectives

This course aims to endow an overall understanding of clinical trials before moving into the field, and for those who already have general or specialist experience of clinical trials and who wish to broaden their role in the design, management, analysis and reporting of clinical trials. The objective of the course is to provide students with a theoretical and practical understanding of the issues involved in the design, conduct, analysis and interpretation of clinical trials. Further the course aims to develop:

• A theoretical and practical understanding of the issues involved in the design, conduct, analysis and interpretation of randomized controlled trials of health interventions.
• Skills to scrutinize information, to critically analyze and carry out research, and to communicate effectively. Describe the uses and applications of the main types of interventive studies: clinical trials and community trials.

Benefits of the Course

The course would equip the students with methodology employed in clinical trials. The course curriculum would provide the students an update knowledge in order to plan and design clinical trials along with the writing of protocols. Following are the other benefits of the course:

• Unique education program with a curriculum that combines business principles, an understanding of the good clinical research practices pertinent to the new therapeutic product research and development industry, and skills necessary for navigating the changing political, regulatory, and financial landscapes in the pharmaceutical and healthcare industries.
• Highly interactive Learning system engages students while remaining convenient for the working professional.
  

Program Fee

BII Program Participation Fee for this program is Rs 10,300 (for participants based in India / USD 750 ( for overseas participants ). Payment is to be made through Demand Draft / At Par Cheque in favor of Bioinformatics Institute of India.

Examination Fees

Every student has to pay Rs.300/- per module as examination fees . Examination fee for overseas participants is USD 30 Per Module

Download the Examination Form

Program Areas

• Module I- Clinical Trials
• Module II- Contract Research
• Module III- Contract Research and Clinical Trial Environment
• Module IV- ICH -GCP Guidelines - International Conference of Harmonization
• Module V- ICMR -Guidelines on Biomedical Research on Human Subjects
• Module VI- SCHEDULE Y
• Module VII- Biostatistics
• Research Study

Clinical trials Industry and Career Prospects

According to BioSpectrum “Trained clinical research professionals will also be in demand abroad. Today, there are more than 2,50,000 positions vacant worldwide. And salaries vary from a minimum of $40,000 per annum for a clinical research coordinator to almost $1,00,000 per annum for a business development manager” .According to McKinsey report, by 2010 more than 50,000 professionals will be required in the field of clinical research in India alone. Many pharmaceutical and clinical research organizations have already come forward to unlock the vast potential India has and, are conducting clinical trials in India. This means science, pharmacy and medicine graduates can look forward to exciting and rewarding career opportunities in clinical research.

Careers in Clinical Research

• Clinical Research Associate
• Clinical Research Investigator
• Study Coordinator
• Data Manager / Biostatistician
• Regulatory Affairs Manager
• Clinical Trials Auditor
• Clinical Project Manager
• Clinical Research Manager
• Business Development Manager
• Drug Safety Associate
• Medical Writer

For further details and enquiries
Call:0120-4320801/02
Mob:09810535368,9818473366
E-mail : info@bii.in

Global Students for any queries

E-mail : global@bii.in,
info@bii.in