About the Institute
Bioinformatics Institute of India, BII has been setup as a premiere institution for the promotion, growth and prosperity of Bioinformatics, Biotechnology and the related sciences. Today it is recognized across the globe as a premier institution offering programs and trainings in the emerging domains of Pharma, Bioinformatics, Clinical trials etc.
The institute aims not only educational and research initiative in this direction but also vouch for creating a talent pool of professionals from various fields who can contribute for the growth and prosperity of Bioinformatics / Biotechnology / Cheminformatics / Biomedical informatics as a career
More >>
Program 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 a clinical trial. 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 or procedures, technological devices, and educational methods.
The main 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.
Program Objectives
The program would endow an introduction to the area of clinical trials, with more detailed coverage of some of the key issues to be considered in their design, analysis, documentation and interpretation.
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 intervention studies: clinical trials and community trials.
- Describe the essential features and stages in the conduct of a clinical trial, and the role of randomization, use of placebo, blinding / masking and intention-to-treat analysis.
- Discuss the ethical issues involved in the conduct of a clinical trial.
Program Methodology
The prospective participants may join the program by submitting Application form with the necessary fees and attachments. The methodology for the program delivery would be:
- Delivery of the lectures by the technically expertise Faculty.
- Guest Faculty from industry and academia would deliver the lectures.
- Along with the theoretical knowledge student would also get a chance to have a practical oriented understanding of the subject e.g. role of computers in Clinical Trials
- E-learning platform via Moodle would also be employed for the classes.
- Students would also be taken for Industrial and Hospitals visits to have an overview of the entire Clinical trial process.
BII Lecture CDs
BII Courseware
Learning Outcome
After completion of the course the participant would be able to:
- Have better understanding of Good Clinical Practice (GCP) and Standard Operating Procedures for Clinical Research.
- Participate in design, conduct and management of Global Clinical Trials, conducted at multicentric sites in India and Overseas.
- Contribute more effectively in their profession - pharmaceutical/Bio pharmaceutical companies in drug development.
- CRO's offering clinical research and clinical data management services, in BIO-IT Life science, Industry or Academic Research institutions.
- As a clinical investigator at hospitals, medical sites conducting trials on subjects.
- Handle regulatory affairs as per the changes in the statutory laws.
BII Blog
BII Blog - is an open interactive knowledge platform
for you. It is meant to be a platform "Of the Participants, for the
Participants by BII". BII Blog will provide the following facilities:
-
Knowledge interchange and exchange among the users.
-
Web based resources.
-
Information sharing on jobs, events etc.
-
Other activities of mutual interest among the users.
So, through this Synchronous Discussions - computer mediated communication
(CMC) participants are able to communicate with other participants of the Institute
to share news, views, comments and opportunities in the domain area.
BII Blog is available on
website. The link is http://www.biinoida.blogspot.com. All program participants are provided access to BII Blog.
Career Prospects
Career prospects include a professional career in Clinical Research industry either as a clinical investigator, site coordinator in at a hospital conducting clinical investigations or CRO (Clinical Research Organization).Jobs are also available in pharmaceutical industry, drug development, medical writing, biostatistics or as a Manager of Clinical Project, Clinical Research Business Development, Clinical Operations, Data Management, Regulatory Affairs and Auditing of Clinical Trials.
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
Projected figures in respect of revenue, human power and patient load for clinical research in India
|
|
2003
|
2008
|
2010
|
| Value (million USD)
|
50
|
200
|
1000
|
| Revenue (crore INR)
|
75
|
300
|
875
|
| Full time staff requirement
|
800
|
4000
|
20,000
|
| Site-staff requirement
|
1500
|
6000
|
30,000
|
| Patient load
|
10,000
|
50,000
|
300,000
|
India today unarguably is the most favored destination for the pharmaceutical R&D and clinical research. The key reasons area:
- 100 million plus English speaking people (Largest outside US).
- Over 2 million science post graduates.
- Large pool of treatment- naïve patients from multiethnic and multiracial backgrounds.
- Easy patient recruitment and compliance.
- Favorable Regulatory Policies – Updated Schedule Y.
- IPR / WTO, GATT on board.
- Cost effective business operations.
- International regulatory approvals for GMP/GLP/GCP.
- Maximum number of approved GMP plants outside USA.
- Excellent quality management, Technology and infrastructure.
- Presence of all Pharma major & also in-house CROs set up by leading pharma companies.
- Presence of all leading international CROs and several domestic CROs – over 75 CROs.
- Strong IT industry availability of IT skilled manpower.
Some of our students are associated with the following renowned companies
| Company Name |
Company Name |
| Panacea Biotech Ltd |
Elder Pharma Ltd |
| Spic Science Foundation |
Sai Mirra Pharma |
| Aventis Pasteur India P. Ltd. |
Glaxosmithkline |
| ANZ Grindlays, ABN Amro, Rabo India |
Macleods Pharmaceuticals Ltd. |
| Lupin Ltd. |
Tata Elxsi Ltd. |
| Charak Pharmaceuticals |
A.I.I.M.S. |
| Datatech Information Study Centre |
Tamil Nadu Veterinary University |
| Bio-Rad Laboratories (I) Pvt. Ltd. |
CMC Ltd. |
| NIIT-GIS Ltd. |
Ranbaxy Lab Ltd. |
| Aurobindo Pharma Ltd. |
Stedman Pharmaceuticals (P)Ltd. |
| Dr. Reddy's Lab |
International Institute Of Biotechnology & Toxicology |
| Cadila Pharmaceuticals Ltd. |
Pfizer Ltd |
| GSK India |
Shasun Chemicals&Drugs Ltd. |
| L&T Information Tech. Ltd. / Polaris Software Lab Ltd. |
Infosys Technologies Ltd. |
| Wipro Technologies |
IPCA Lab |
| ANR Right Gen Technology |
Deptt. Of Plant Molecular Biology Univ. Of Delhi |
| Novartis India Ltd. |
N.B.F.G.R. |
| National Informatics Centre (Govt. Of India) |
Netaji Subash Institute Of Tech (N.S.I.T.) |
| IICB |
Fippat |
| Ecosolar Systems (I) Ltd. |
M.E.I. Polytechnic |
| National Institute Of Oceanography |
Nagpur Test Tube Baby Centre |
| Coffee Board-Biotech Centre |
Program Duration
The Program Duration is 6 months.
Program Eligibility
The eligibilty for the training program is graduation in any discipline.Highly interested participants in final year can also apply. The program is most suitable for Doctors, medical professionals, pharmacists etc.
Attendance
A minimum of 75% attendance is compulsory, failing which the students will be debarred from appearing in any examination and he/she will have to repeat the term.
Discipline
Students are expected to follow the code of discipline failing which action, as considered necessary, including rustication may be taken at the discretion of the Director. These rules are displayed on the notice board
Evaluation
The candidate will be evaluated throughout the program tenure by submitting the assignments, research study.Practical evaluation will be done through the practical classes, assignments and documentation work of clinical trial program.
Final evaluation of the candidates would be on the basis of examination conducted at the end of the program.
Faculty
Lectures of the Advance Program in Clinical Trials will be taken by expertise faculty.
Dr.Kumud Sarin Ph.D View Profile
Dr. Neena Valecha View Profile
Dr. Anirban Das Ph.D View Profile
Mr. G.K. shrivastava (Clinical Trial Specialist) View Profile
Fee Structure
Total Course Fee Rs. 35,000
Payment in Installments can also be made.
Admission Procedure
- Submission of Application Form along with the demand draft of Rs. 300 /- in favor of Bioinformatics Institute of India, payable at Delhi / Noida.
-
Enclosures :
- Mark sheets: Two sets of Xerox copies of Mark-sheets of qualifying/last attended examination
- High School, Higher Secondary (10+2), Graduation, Post Graduation.
- Photographs: Two recent passport size photographs.
- Envelopes Three Self Addressed Envelopes, duly Stamped should be enclosed with the application form.
-
Personnel & Telephonic Interview.
The classes would commence from 15th December, 2008.
Last Date for registration is 30th Nov,2008.
Program Curriculum:
For further details and enquiries
Program Co-ordinator
Advance Program in Clinical Trial, Research and Data Management
Bioinformatics Institute of India
C-56 A/28, Sector - 62
Noida - 201301, UP(INDIA)
Tel : 0120 - 4320801/02
Mob : 09818473366 ,09810535368
E-mail : info@bioinformaticscentre.org
support@bioinformaticscentre.org
Home
