Clinical Research Department

Clinical Research Department

Overview

Overview Image

The Clinical Research Department at Bhaktivedanta Hospital & Research Institute, Mira Road undertakes and promotes Scientific & Ethical research studies for new & better outcomes in patient treatment, care and in healthcare field.

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 necessary to conduct clinical trials of drugs, medical devices, and surgical trials. We have successfully completed CRO and Sponsor Quality Analysis audits without any hassles. A dedicated team of experienced, GCP trained Investigators, Coordinators, and QA Manager work together to ensure study protocol compliance.

The Medical Research department was established in the year 2013 and is credited for conducting more than 50 Indian/Global Clinical trials and around 90 hospital-initiated research projects within short duration. Our department is working with more than 35 different pharmaceutical company and Contract Research organization (CRO) for different clinical trial projects.

Achievement of Clinical 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’

Courses

Overview

The Post-Graduation in Clinical Research courses at our institute not only equips candidate to understand Clinical Research but also helps them understand it practically. Immaterial of what calamity, for that matter even in covid-19 pandemic, the need of Clinical Research is felt more and more. Any nation stands unique only through Research and Innovation. Young and intelligent minds must pursue Clinical Research as career as it is intellectually and financially 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. The findings of the research 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.

  • 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
Full-time Course Duration 1-year
Batch Size: 15 students only

Course Curriculum: The Full-time one-year duration course is a unique clinical research course that blends classroom learning through series of lectures and hands-on training.

Highlights of the Course:
  • Lectures are conducted by doctors
  • Guest lectures by Clinical Research Industry Professionals
  • Case study learning
  • Tailored Individual Student Mentoring
  • Hands-on training on conduct of Clinical Trials and Investigator initiated research
  • Application based assignment for each module
Module of the Course:
  • 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

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

Limited Batch Size - 15 Students only
Online Course Duration 6- months
Highlights of the PGCR Course:
  • This Clinical Research course blends E-Learning through series of lectures.
  • Weekly lectures session by Experienced faculty
  • Guest lectures by Clinical Research Industry Professionals
  • Practical lecture series by Research Investigators and Ethics Committee Members
  • Case study learning
  • Internship Opportunities for the candidates
Batch Size: 15 students only

Course Curriculum: The Full-time one-year duration course is a unique clinical research course that blends classroom learning through series of lectures and hands-on training.

Highlights of the Course:
  • Lectures are conducted by doctors
  • Guest lectures by Clinical Research Industry Professionals
  • Case study learning
  • Tailored Individual Student Mentoring
  • Hands-on training on conduct of Clinical Trials and Investigator initiated research
  • Application based assignment for each module
Module of the Course:
  • 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

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

Limited Batch Size - 15 Students only
Highlights of the PGCR Course:
  • This Clinical Research course blends E-Learning through series of lectures.
  • Weekly lectures session by Experienced faculty
  • Guest lectures by Clinical Research Industry Professionals
  • Practical lecture series by Research Investigators and Ethics Committee Members
  • Case study learning
  • Internship Opportunities for the candidates

What we offer ?

Internship

Candidate enrolling for our courses need not invest time for internship post completing the course. Our institute provides internship opportunities within the campus of the Bhaktivedanta Hospital & Research Institute. With the hospital facilities to conduct the clinical trials, Specialist Doctors (who are Investigators and can undertake any complex clinical trial), dedicated Research Associates, Research Medications, National & International Clinical Trials, state-of-the-art facility to undertake any clinical trial, govt accredited Research Committees, NABH Assessors at site, our institute has all resources available to give best exposure to our candidates. Each Student will be assigned few Clinical research projects since beginning of course itself and will be provided ‘Internship certificate’ at the end of course.

Hands on Training:

We don’t believe in only theory classes or internship at the end of classes. Both must happen simultaneously to understand the subject matter thoroughly, hence we encourage hands on training at the same time. 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.

Students 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 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 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 Visits of Qualification, Selection, Initiation Monitoring, Assessment, Audit, Close Out and more
  • Opportunity to understand functioning of committees like Institutional Ethics, Biomedical Research, Investigator Initiative Study Research, Scientific
  • 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 train our students as per the industry standards and help them become successful Clinical Research Professionals.

Training
  • Soft Skills for a Clinical Research Professional
  • Customizing Resumes and preparing students for Job interview
  • Personal Assistance for Job Placement of student across Hospitals, Pharmaceutical companies, Contract Research Organizations (CRO), Site Management Organizations (SMO), Research Hospitals

Education & Career

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)
  • Quality Auditor