Clinical trials are research studies that test new drugs and treatments on people. This 12-month course provides students with a theoretical and practical understanding of how to design, conduct, analyze, and interpret clinical trials. Students will learn about clinical trial methodology, regulations, and ethics. The course aims to equip students with the skills needed for careers related to clinical research such as clinical research coordinator, associate, investigator, and manager. There is high demand for professionals in the growing field of clinical research in India and abroad.

1. 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.

2. 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.
Eligibility : Any Science Graduate
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

3. 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
BIOINFORMATICS INSTITUTE OF INDIA
H-109, Ground Floor Sector-63
Noida - 201 307 (U.P) (INDIA)
Call : 0120-4320801/02 Mobile : 09818473366,09810535368
E-mail : info@bii.in Website: www.bii.in