Clinical Trials, Research and Data Management (6 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 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.

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.

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.

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 Research Manager
• Clinical Project Manager
• Business Development Manager
• Drug Safety Associate
• Medical Writer

India today unarguably is the most favored destination for the pharmaceutical R&D and clinical research. The key reasons are:

• 100 million plus English speaking people (Largest outside US).
• Over 2 million science post graduates.
• Large pool of treatment- naive 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.

Program Duration : The Program Duration is 6 months.

Program Eligibility

The eligibility for the program is Graduation/Post Graduation in Life Science. 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.

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.

Fee Structure

Total Course Fee Rs. 45,000 (Student can pay in installment Rs. 15,000 each)

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.
• Registration Fee for Regular Program is Rs. 5,000.
• 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.

 

Program Curriculum:

• Module-I Clinical Trials and Clinical Trials Environment
• Module-II Statistics for Clinical Trials
• Module-III Clinical Data Management
• Module-IV Contract Research
• Module-V Regulatory Affairs, Good Clinical Practices, Pharmacovigilance and Ethics
• Module-VI Medical Writing and Documentation
• Module-VII Practical
• Module-VIII Research Study

For further details and enquiries

Program Co-ordinator

Advance Program in Clinical Trials, Research and Data Management

BIOINFORMATICS INSTITUTE OF INDIA
C-56A/28, Sector - 62,
Noida - 201301
(INDIA)
Tel : 0120-4320802
E-mail : kumud@bii.in