6 - 8 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week
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 Start Date
Why study this program?
Clinical studies are an essential component of the much larger R&D landscape for bringing safe and effective medicinal products to the marketplace. Along with this fundamental and legitimate concept, pharma-biotech sector and the community at large are acknowledging the need to speed up the methods of drug development so that the discoveries of the laboratory are not shelved but rather successfully translated into clinical practice.
New drug development is a time consuming, and costly undertaking. The cost of bringing a new molecule from the bench to the bedside has surpassed US $800 million. From an financial point of view the pharmaceutical and biotechnology sector are constrained to effectively utilize their resources with an approach to be able to consistently invest in new product pipelines. This has resulted the clinical research sector to get attracted to strengthening economies such as India, China, Brazil and South-East Asia. As per a US FDA report, since 1997 the number of clinical studies in these developing regions has grown at the rate of 8% annually.
In today's scenario where the number of service providers such as contract research organizations (CROs), site management organizations (SMOs) etc are growing every year globally, there is an unmet need for scientifically driven strategic business development to enable organizations gain more business and revenue.
At JLI, we recognize the simple fact that clinical research is a scientific exercise that requires professionals in contact with potential sponsors to have a strong knowledge of clinical research coupled with the art of marketing and this program has been designed to achieve just that.
What will be taught?
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.
How will I be assessed?
You will be assessed on an ongoing basis by the faculty based on the following criteria:
One is the completion of the online multiple choice question tests that follow each lesson; and second is the timely submission of assignments for each study module within the JLI e-Campus.
Your academic performance in the program will be assessed on a 4 point GPA scale. More details about our evaluation system is available in the following link: Evaluation System
Am I eligible?
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.
What support will I receive?
As a student you can interact online with the faculty members and fellow students to network and to discuss important topics via your e-Campus. The faculty promptly answers all questions related to the study in the Online Campus Tutoring Center (OCTC).
Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.
In addition, each participant registered in the Advanced Post-Graduate Diploma in Clinical Research & Business Development Course is provided with a mentor who is an experienced professional from the clinical research industry. The mentor can be contacted at any time via email or phone.
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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.
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.