Post Graduation in Clinical Research

About Bhaktivedanta Hospital & Research Institute

Introduction

The Medical Research Department at Bhaktivedanta Hospital & Research Institute, Mira Road undertakes and promotes Scientific & Ethical research studies for New & better outcomes in patient treatment and care / Healthcare area.

We are conducting Clinical Trials in collaboration with more than 50 National/Global Sponsors as well as Clinical Research Organisations in various Multispecialty Clinical Research Projects since 1998. The Medical Research Department is well equipped with all essential facilities which are necessary to conduct clinical trials of drugs, medical devices, and surgical trials. We have successfully completed CRO and Sponsor Quality Analysis audits without any significant findings. A dedicated team of experienced, GCP trained Investigators, Co-ordinators, and QA Manager Work together to ensure study Protocol compliance.

We are a tertiary care, Multispeciality 300 bedded hospital, NABH accredited, serving Mumbai-Thane sub urban area in the last 20 years. Medical Research department of BhaktiVedanta Hospital is established in year 2013, has conducted more than 50 Indian/Global Clinical trials and around 90 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.

Courses

Post-Graduation in Clinical Research course at our Institute not only equips candidate to understand Clinical Research but also allows actual conduct of it. Immaterial of what calamity, for that matter even in covid-19 pandemic need of Clinical Research is felt more and more. Any nation stands unique only through Research and Innovation. Young and intelligent minds must explore this aspect as career as it is intellectually and even financially very much satisfying.

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.

  • Course Curriculum : This unique Clinical Research course in blending of Classroom Learning through series of lectures and Hands on training
  • lectures sessions by Doctors
  • Guest lectures of Clinical Research Industry professionals
  • Practical lecture series from Research Investigators and Ethics Committee Members
  • Case study learning
  • Tailored Individual Student Mentoring
  • Hands on training on actual conduct of Clinical Trials and Investigator Initiated Research.
  • Application based Assignment for each module

Course Evaluation :- There would be separate exam for every module. Candidates need to score at least 80% to be eligible for the next module. There would be additional Final exam which will be based on all the modules.

  • 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 Pharmaco-vigilance
  • Module IX – Soft Skills Training
  • Module X – How to appear for Interviews
Limited Batch Size - 15 students only
  • Duration Of Course : 6 month, Full time Course
  • 6 Month online PGDCR Course :
    • This Clinical Research course in blending of E-Learning through series of lectures.
    • Weekly lectures session by Experienced faculty.
    • Guest lectures of Clinical Research Industry professionals
    • Practical lecture series from Research Investigators and Ethics Committee Members
    • Case study learning
    • Internship for interested candidates.
  • Internship - What a wonderful concept. No need to again invest time for internship post completing the course. Complete your internship while doing the course. As Bhaktivedanta Hospital has all required resources to provide internship , namely , patients , Research Medications , National & International Clinical Trials , hospital facility to conduct these clinical Trials , Specialist Doctors who are Investigators and can undertake any complex clinical trial , dedicated Research Associates , state of the art facility to undertake any clinical trial , govt accredited Research Committees , NABH Assessors at site .Each Student will be assigned few Clinical research projects since beginning of course itself. Student will be provided ‘Internship certificate’ at the end of course which distinguish him/her during Job application process.
  • Hands on Training : We don’t believe in only theory classes or internship at the end of theory classes. Both must happen parallel so as to understand the subject matter thoroughly, and hence we are offering hands on training simultaneously . During course student will be exposed to ‘live –Clinical Research Operation’ process. It will help student to correlate classroom learning to practical Clinical Research operations. Student will get opportunity to have following hands-on trainings :
    • Opportunity to work with centralized Medical Research Department. Clinical Trials of all specialties, all clinical trials phases, various indications are happening in centralized Medical Research Department.
    • Opportunity to directly conduct International Clinical Trials.
    • Opportunity to receive direct training from Sponsors, Contract Research Organization, Medical Monitors and Principal Investigators
  • Opportunity to learn communication skills to deal with external vendors required for Clinical Trials (Monitors, Clinical Research Associate, Interactive voice response system Representatives, Interactive Web Response representatives, Drug Controller General of India Office personnel, NABH Personnel , Ethics Committee Personnel)
  • Opportunity to directly report Clinical Trial Safety Information to Head of Institute, DCGI and Sponsors
  • Opportunity to participate in Site Qualification Visit, Site Selection Visit, Site Initiation Visit, Site Monitoring Visit, Site Assessment Visit, Site Audit Visit, Site Close Out Visit.
  • Opportunity to understand functioning of Institutional Ethics Committee, Committee for Biomedical Research, Committee for Investigator Initiative Study Research, Scientific Committee.
  • Opportunity to directly network with CRO Sponsor so that it is easy to get good placements.
  • Clinical Trial Start up activities including Informed Consent Process
  • Data Management - electronic data entry software
  • 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
  • Career in Clinical Research :
    • Biostatistician
    • Clinical Data Management (CDM)
    • Clinical Research Associate (CRA)
    • Clinical Research Coordinator
    • Clinical Research Scientist
    • Clinical Trial Manager
    • Clinical Trial Monitor
    • Pharmacovigilance Associate (PVA)
    • Regulatory Affairs Manager (RAM)
    • Quaility Auditor
  • Eligibility for the Course :
    Minimum eligibility criteria for application to the course would be either of the following :
    • Graduates in Life sciences / Bio Sciences - (Biochemistry, Microbiology, Genetics, Biotech, Biology etc.)
    • Physiotherapy, Occupational Therapy, Nursing Graduates
    • Pharmacy Graduates
    • Medical Graduate- MBBS, BAMS, BDS, BHMS
  • How to Register for these courses :
    Follow following 3 steps for registration of any of the courses :

    Note : Documents required as per steps 1, 2 & 3 can be
    WhatsApp on 9320199122 , 9167774038 or
    Email to drvijaykumar.g@bhaktivedantahospital.com , pgdcr@bhaktivedantahospital.com

    • Step 1 : Application form fees For NEFT Transaction of Form Fees Rs 1000 : Sri Chaitanya Seva Trust , Axis Bank - Mira Road, Account Number : 916010017610073 , IFSC Code : UTIB0000573. Fees Transaction details required to be shared
    • Step 2 : Share Scan copy of FILLED Application
    • Step 3 : Solve the Aptitude test
  • 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’

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