Course - Post Gradulate Diploma in Clinical Research And Business Development

COURSES

James Lind institute conforms to the best practices for web based learning. A skills gap analysis is conducted when a new student enrolls at JLI. Availability of tutors for each student helps to overcome the gap by relevant instructions which are both course oriented as well as for grasping the soft skills. Tutors also help students to keep themselves motivated and focused.

Advanced Post-Graduate Diploma in Clinical Research
and Business Development

Clinical trials are a vital component of the larger research and development landscape for getting safe and efficacious healthcare products to the market. Along with this basic and genuine concept, pharmaceutical industry and the society at large are recognizing the need to expedite the processes of drug development so that the basic science discoveries are not shelved but get efficiently translated into clinical practice.

Drug development is a length, and expensive endeavor. The cost of getting a drug or biologic from the bench to the bedside has crossed $800 million. From an economic standpoint the pharmaceutical and the clinical research industry is constrained to channelize their recourses with a strategy to be able to constantly fund the drug pipelines. This has effected in a drift of the clinical research industry towards India, China, Latin America and South-East Asia. According to a US Food and Drug Administration report the number of clinical trials in these new hubs of clinical research has grown at a rate of 8% each year since 1997.

In this pharmaceutical industry scenario and growing number of clinical research management organizations worldwide (CROs, SMOs, Clinical research consultancies, etc.), the need for scientific and strategic business development is well recognized.

We at the James Lind Institute understand the fact that clinical trials are a scientific activity requiring professionals in contact with clients to have a firm understanding of the science of clinical research and the art of marketing.

This course develops students to enter this exciting, challenging and highly rewarding discipline as “Scientific business development associate / manager” in the pharma-biotech or clinical research industry. The students of the APGDCR-BD course at JLI develop the skills necessary to find business leads, mature them into prospects and finally closing the deals with sponsors or vendors.

The APGDCR-BD course curriculum is fully reviewed and endorsed by the Industry and the academia thus helping students to acquire that edge they require to enter the business development sector. This course is also beneficial for professionals working in the clinical research or pharmaceutical industry to take up a business development role.

Course Structure

MODULE 1 GENERAL INTRODUCTION
MODULE 2 EPIDEMIOLOGY AND EVIDENCE BASED MEDICINE
MODULE 3 PHARMACEUTICAL MEDICINE
MODULE 4 THERAPEUTIC AREAS
MODULE 5 ETHICS IN CLINICAL RESEARCH
MODULE 6 ROLES AND RESPONSIBILITIES
MODULE 7 CLINICAL TRIAL PREPARATION
MODULE 8 ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 9 STUDY START-UP
MODULE 10 CLINICAL TRIALS MONITORING
MODULE 11 REGULATORY AFFAIRS IN CLINICAL RESEARCH
MODULE 12 COMPLIANCE AND AUDITS
MODULE 13 DATA MANAGEMENT AND BIOSTATISTICS
MODULE 14 MEDICAL DEVICE TRIALS
MODULE 15 PROJECT AND VENDOR MANAGEMENT
MODULE 16 FINANCIAL MANAGEMENT OF CLINICAL TRIALS
MODULE 17 PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS

BUSINESS DEVELOPMENT

MODULE 1 MARKETING INNOVATION AND SERVICE
MODULE 2 ADVANCED FINANCIAL MANAGEMENT
MODULE 3 INTERNATIONAL BUSINESS DEVELOPMENT
MODULE 4 BUSINESS LAWS
MODULE 5 CORPORATE COMMUNICATIONS

The later part of the course would involve mock exercises concerned with a real-time role review of a Clinical Research Professional in different capacities.

Course duration

Self Paced 8 - 10 months

A student enrolled for the Advanced Post Graduate Diploma in Clinical Research & Business Development (APGDCR-BD) course is expected to study online for a minimum of fifteen hours per week.

Course Assessment

Course assessment involves online MCQs for each lecture, followed by assignments and numerous assessments by tutors in the “Online Campus Tutoring Centre” by the method of interactive discussion.

Eligibility Criteria

The minimum eligibility criteria for the course would include either of the following:

MBBS/BHMS/BAMS/BPT/MPT/BDS/BMLT/Bachelor in Naturopathy & Veterinary Science /MD/MS.
Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences.
Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).
Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics.
Graduate or equivalent degree in Nursing/Allied Health.
Students in their final year of graduation for the above courses may also apply.

Fee Structure

Course fee for the Advanced Post Graduate Diploma in Clinical Research & Business Development (APGDCR-BD) course for 2010-2011 is INR 22,500.
For more details about admissions click here

Academic Support

Each student in the APGDCR-BD course is assigned a mentor throughout the course who will be a senior professional from the Industry. Students are in close contact with the “Student Success Team” during the course and thereafter as alumni. To know more about the “Student Success Team”, click here

In a global clinical trial market report by Visiongain the total clinical trials business was worth $50 billion in 2008 and is growing at a rate of 10% each year. This business projection shows the need of and opportunities for business development managers in the clinical research industry.