Post Graduate Diploma in Clinical Research

Bhaktivedanta Hospital and Research Institute offers Full time ‘Post Graduate Diploma in Clinical Research’. This Clinical Research course is blending of Classroom learning and Hands on training. This unique clinical research training course provides you with a thorough understanding of all important and relevant knowledge areas of drug development and clinical research management.


About Clinical Research


   Clinical Research is a branch of medical science, related to the effectiveness and testing of medications, diagnostic products, medical devices and treatment procedures for human use. These can be used for a disease’s treatment, prevention, diagnosis or for relief. Clinical research refers to the comprehensive bibliography of biology, drugs, and devices.


Scope of Clinical Research


Clinical Research is a fast growing industry, the global clinical trial service market is expected to reach more than $64 billion by 2020, up from $38.4 billion at present. India has been involved in clinical research for the past many years and is now on its way to becoming a major hub for it. The billion dollar industry is already witnessing high demand for qualified professionals across Pharmaceutical companies, Contract Research Organizations (CRO), Site Management Organizations (SMO), Research Hospitals and Government Regulatory body.


Carrier options in Clinical Research


  To enter in Clinical Research field, person must have at Medical/Pharmacy/Nursing/Life Science degree along with professional course in Clinical Research.  Person having hands on training or internship experience is always preferred over fresher for entry level positions.  Following are various carrier options in Clinical Research field across various organizations



  • Clinical Research Coordinator

  • Clinical Research Associate

  • Pharmacovigilance/Data safety associate professionals

  • Data Management professionals

  • Medical Writing

  • Regulatory affairs

  • Business development executive


About Bhaktivedanta Hospital and Research Institute


   We are a tertiary care, Multispecialty 200 bedded hospital, NABH accredited, serving Mumbai-Thane sub urban area since 20 years.  Medical Research department of BhaktiVedanta Hospital is established in year 2013, has conducted more than 40 Indian/Global Clinical trials and around 50  hospital initiated research projects within short duration. Hospital is working with more than 35 different pharmaceutical company and Contract Research organization (CRO) for different clinical trial projects.


Achievement of Medical Research Department



  • NABH accreditation of Clinical Trial – 1st Institute in Maharashtra and 2nd Institute in India

  • Registered under US Govt - Department of Health and Human Service as a  'Research Institute'  (FWA registration)

  • Recognized Research Institute with USFDA (GDUFA FEI No-3010542690)

  • Ethics Committee registered under Union Health Ministry, New Delhi

  • Prestigious ‘Worldwide Achiever Award 2015 - Best Multispecialty Hospital for Innovation and Research’


Course Objective


    This Post Graduate Diploma in Clinical Research Course equips you with the knowledge and skills required for making a successful career in Clinical Research.The program has been designed in a way so as to compliment your basic education and to provide you a platform to enter the pharmaceutical and healthcare industry as a clinical research professional.


Eligibility


Minimum eligibility criteria for application to the course would be either of the following:



  • Medical Graduate- MBBS, BAMS, BDS,BHMS

  • Physiotherapy, Occupational Therapy, Nursing Graduates

  • Pharmacy Graduates

  • Graduates in Life sciences/ Bio Sciences-(Biochemistry, Microbiology, Genetics, Biotech, Biology etc.)


Duration of course- 10 months, Full time


Limited Batch Size- 10 students only


Application and selection process


Candidate need to submit detail application form along with required documents and Application fee Rs 1000.  Selection procedure is based upon following evaluations



  • Education Background

  • Entrance test (MCQs)

  • Interview


Course Curriculum


This unique Clinical Research course in blending of



  • Classroom Learning through series of lectures

  • Weekly lectures session by Experience faculty

  • Guest lectures of Clinical Research Industry professionals

  • Practical lecture series from Research Investigators and ethics committee members

  • Case study learning

  • Application based Assignment for each module


Course Evaluation- Total 10 Credit point includes 8 Applied Clinical Modules and Applied Research Projects


 Course will be delivered through 8Applied Clinical Modules (1 Credit Point Each)



  • Module I – Basic of Clinical Research and stakeholders in Clinical Research

  • Module II – Basic Pharmacology in Clinical Research and New Drug Development

  • Module III – Ethics in Clinical Research and Ethical Guidelines

  • Module IV – Regulations in Clinical Research (Indian and Global)

  • Module V – Clinical Research Methodology

  • Module VI – Clinical Trial Monitoring, Audits and Inspections

  • Module VII– Clinical Data Management

  • Module VIII – Drug Safety and Pharmacovigilance



  • Practical Learning through Hands on training and Internship


A unique feature of this course is ‘Hands on Training’ and Internship. 



  • Internship- Each Student will be assigned one Clinical research projects as ‘Intern’ since beginning of course. Student will be provided ‘Internship certificate’ at the end of course which distinguish him/her during Job application process.

  • Hands on Training


During course student will be exposed to ‘live –Clinical Research Operation’ process. It will help student to correlate class room learning to practical Clinical Research operations. Student will get opportunity to have following hands on trainings



  • Clinical Trial Start up activities

  • Informed Consent Process

  • Data Management- electronic data entry software

  • Serious Adverse Event Reporting and safety data entry process

  • Ethics Committee Communications

  • Clinical Research Operation



  • Applied Clinical Research Projects (2 credit Point)

    Each student will conduct Individual Clinical Research Project under supervision of Hospital Investigator during course tenure.  It includes complete start to end activities of research process from design of research projects, Ethics Committee submission and approval, data collection, Data Analysis and presentation.



    • Stage 1: Design of a research proposal   (1 Credit Point)

    •   Stage 2: Conducting Research - Data collection, Data Analysis and presentation. (1 Credit Point)




Placement Assistance


We will groom our students to face industry. We will work with them to make  future successful Clinical Research Professionals.



  •   Training -Soft Skills for a Clinical Research Professional

  •   Training-Resume customization and Job interview preparation

  •   Personal Assistance for Job Placement of student across Hospitals, Pharmaceutical companies, Contract Research Organizations (CRO), Site Management Organizations (SMO), Research Hospitals


For Admissions, Contact Us



  • Medical Research Department, 5 Floor

    Bhaktivedanta Hospital and Research Institute


    Srishti Complex, Mira Road (East) Thane MH India- 401107



  • Phone- 09326192487

  • Email : pgdcr@bhaktivedantahospital.com