The drug and medical device development industry is experiencing a tremendous change globally. This change has geared momentum towards development of unique, newer and safer therapies and towards personalized medicinal drugs. The business models are advancing to the higher levels of niche busters and towards a coexistence of newer and blockbuster therapies used in the past.
Due to the strengthening of economies in the BRIC countries i.e. Brazil, Russia, India & China, drug and device companies are focusing their research and development efforts in these regions particularly the research for clinical development of products i.e. Phase I to Phase IV clinical trials. Further, local pharmaceutical and biotech companies in these regions are also rapidly stepping up their work in Research and Development for developing promising new molecules as well as generics.
The growth of this industry has amplified the demand for trained staff in the clinical research industry. This M.Sc in Clinical Research equips you with the knowledge and skills required for making a successful career in drug development and clinical trials. The program has been designed in a way so as to provide you a platform to enter the pharmaceutical and biotech industry as a clinical research professional. The program is suitable for fresh graduates as well as experienced industry professionals.
The program is comprised of 90 ECTS credits and can be completed in about 18 months. For a detailed list of courses taught in this program, please refer to the curriculum.
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: ADVANCED FINANCIAL MANAGEMENT
MODULE 18: PROJECT MANAGEMENT (BASED ON PMBOK)
MODULE 19: CLINICAL PROJECT MANAGEMENT OVERVIEW
MODULE 20: PRINCIPLES OF PHARMACOVIGILANCE
MODULE 21: PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES
MODULE 22: PHARMACOVIGILANCE SYSTEMS
MODULE 23: GLOBAL PHARMACOVIGILANCE AND SAFETY STANDARDS
MODULE 24: PHARMACOVIGILANCE REGULATIONS AND GUIDELINES
MODULE 25: PHARMACOEPIDEMIOLOGY
MODULE 26: BASICS OF GOOD MEDICAL WRITING
MODULE 27: BASICS OF CLINICAL DATA MANAGEMENT
MODULE 28: QUALITY & QUALITY MANAGEMENT
MODULE 29: THE QUALITY ASSURANCE FUNCTION
MODULE 30: AUDITS
MODULE 31: QUALITY GUIDELINES
MODULE 32: GCP/GMP/GLP
MODULE 33: BUSINESS LAWS
MODULE 34: CORPORATE COMMUNICATION
This program is conducted fully online.
Once you are enrolled you will be provided a username and password to login to our e-Campus. All the courses that you are supposed to study will be available in your account. You can log in and complete your courses at any time of your convenience. Study materials are provided in the form of lectures, reading materials, additional videos, research papers, and so on. The faculty can be contacted for any assistance when required. All tests and assignment submissions also take place via the e-Campus. For more information please refer to the online learning section of the website.
Bachelor's degree (or equivalent / higher)
This program requires a bachelor’s degree or an equivalent recognized academic title, preferably in a life science-related area. If you are unsure about your eligibility, please reach out to our admission staff.
This program is taught in English. Therefore, you should be comfortable in using English as a language of communication (reading, writing and speaking). If you have taken an English language test in the last two years, that is good to have. If not, you can explore a waiver for the English language test.
The English proficiency test is waived-off for the following candidates:
- Native English speakers, OR;
- Applicants who have completed their previous qualifications (e.g. bachelor’s degree) in English language, OR;
- Applicants who have at least 2 years of work experience in an organization in which English is the primary language of communication.
Our program fees are very reasonable in comparison to other schools. Please calculate the fees applicable to you by using our online fee calculator.
The program is conducted in our e-Campus. The login credentials are provided to each student upon enrollment. The e-Campus contains all the study materials and academic resources needed by you during the program. As a student, you can log in and work through your assigned courses at any time. The faculty members are available for any assistance throughout the program.
Multiple Choice Question Tests & Assignment Submissions
Throughout the program you will be assessed on an ongoing basis via multiple choice question tests and assignment submissions.
Assignments contribute 40% towards the overall final grade of each course.
This program can be completed in about 1.5 years. It is fully self-paced, so you can increase your pace or go slow based on your time availability.
The primary mode of learning is via pre-recorded lectures, videos, reading materials etc. A few live guest lectures are scheduled during the program however they are optional to attend. Whenever such sessions are scheduled they are planned in a way that is convenient for most of our students. If you are unable to attend, a reccorded version will be provided.
You will be able to interact with the faculty via the personal messaging facility available in your study account, discussion forum, or via emails. A short phone call can also be scheduled if necessary.
A discussion group is available for the program. You can post your questions in the group and other students may respond.
Generally, you do not need to purchase any books. All the resources that you need will be made available by the faculty in your account. If you do wish to have text books, then the faculty can recommend to you some, and you may purchase them on your own,
Please refer to the assessments section in this page above.
You can save the pdf study notes that will be provided for each unit. Videos and other multimedia content cannot be downloaded.
Once you are nearning the completion of your coursework, you will work with your mentor to finalize a topic. You will then work on your dissertation under the guidance of your mentor and submit it once complete. The word count required is a minimum of 20000 words. You may be required to defend the dissertation as per the applicable academic policies.
No, our degree does not mention that the program was conducted online.
A virtual graduation ceremony may be conducted for which you will be invited to join via video-conferencing. After this the completion documents are sent to your postal address by courier.