Clinical Development Sciences

PROGRAM DURATION

6 - 8 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week

Advanced PG Diploma in Clinical Research & Business Development

In addition to providing you with a thorough understanding of clinical trials the program will also equip you with the knowledge and skills essential to creating strategic business plans, identifying new clients and closing business deals.

TOTAL CREDITS: 32

Next Commencement Date

01 SEP

2019

Apply Now

INTRODUCTION

Why study this program?


Introduction

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 lengthy, 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.

PROGRAM STRUCTURE

What will be taught?


Program Structure

MODULE 01: GENERAL INTRODUCTION
MODULE 02: EPIDEMIOLOGY & EVIDENCE BASED MEDICINE
MODULE 03: PHARMACEUTICAL MEDICINE
MODULE 04: THERAPEUTIC AREAS
MODULE 05: ETHICS IN CLINICAL RESEARCH
MODULE 06: ROLES AND RESPONSIBILITIES
MODULE 07: CLINICAL TRIAL PREPARATION
MODULE 08: ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 09: STUDY START-UP
MODULE 10: CLINICAL TRIALS MONITORING
MODULE 11: COMPLIANCE AND AUDITS
MODULE 12: DATA MANAGEMENT AND BIOSTATISTICS
MODULE 13: REGULATORY AFFAIRS IN CLINICAL RESEARCH
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
MODULE 18: MARKETING INNOVATION AND SERVICE
MODULE 19: ADVANCED FINANCIAL MANAGEMENT
MODULE 20: INTERNATIONAL BUSINESS DEVELOPMENT
MODULE 21: BUSINESS LAWS
MODULE 22: CORPORATE COMMUNICATIONS

TOTAL CREDITS: 32

MODE OF STUDY: ONLINE

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.

ASSESSMENT

How will I be assessed?


Assessment

Course assessment involves online multiple choice questions for each lecture, followed by assignments for each study module.


Overall academic performance in the program is measured on a 4 point Cumulative Grade Point Average (CGPA) scale. More information about this is available here: Evaluation System

ELIGIBILITY

Am I eligible?


Eligibility

The minimum eligibility criteria for Advanced Post-Graduate Diploma in Clinical Research & Business Development (APGDCR-BD) would include either of the following:

- Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
- Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
- Any degree in Pharmacy / Pharmaceutical Sciences
- Any degree in Chemistry / Biostatistics / Bioinformatics
- Any degree in Nursing / Allied Health.
- Students in their final year of graduation for the above courses are also eligible to apply.

Candidates without any science background such as graduates in business administration or candidates with some work experience in the pharmaceutical industry / allied areas may also be eligible for this program. Please check with our counsellors for more information.

ACADEMIC SUPPORT

What support will I receive?


Academic Support

Throughout the course, the students can interact with the faculty and other students via the e-Campus to discuss any coursework related issues.


Each student enrolled in the Advanced Post-Graduate Diploma in Clinical Research & Business Development Course (APGDCR-BD) is also assigned a mentor throughout the course who will be a senior professional from the industry. Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.

Receive More Information

Enter your email id and we will instantly send you more information about this program
more info


Program Fee

How much will it cost?
Please use our online fee calculator to calculate the fee applicable to you.



CAREER OPPORTUNITIES

This online clinical research & business development training program prepares you to enter the pharma-biotech or clinical research industry as “Business Development Associate, Executive or Manager”. The program also prepares you to explore positions in clinical operations such as clinical research associate, clinical research manager and many others.


MORE INSIGHT

The clinical research industry is struggling to find people who have good marketing experience along with a thorough understanding of the core concepts of clinical research. The later is the key to interacting with potential clients in understanding their requirements, problems at hand and providing innovative solutions.


james lind institute
James Lind Institute (India) - Golden Square, 2nd floor # 579 32nd D Cross Road, 10th Main Rd, 4th Block, Jayanagar, Bengaluru 560011 | Phone: +91-80-46473435, +91 40 42023318,
James Lind Institute (Singapore) - 16 Collyer Quay Level 18, Singapore 049318 | Phone: +65 31631880
James Lind Institute (US) - 244 5th Avenue, Suite C-155 , New York 10001 | Phone: +1 866-259-4781 (Toll Free), +1-718-362-6065