OVERVIEW

The Medical Research Department at Bhaktivedanta Hospital & Research Institute undertakes and promotes Scientific as well as Ethical research studies dedicated towards new outcomes for better patient treatment and care. The department is centralized and co-ordinates with all the clinical departments of the Hospital to facilitate Investigator Initiated and Sponsored Clinical Trial research projects. The Medical Research Department enhances the strength of the Hospital with distinguished competent clinicians and clinical researchers. The Hospital supports the effective functioning of the Medical Research Department through a variety of patients, state-of-the-art diagnostic and therapeutic technologies and an excellent medical record system.


KEY FEATURES





  • Established SOPs in compliance with GCP guidelines, Schedule Y, QCI and other international requirements




  • Experienced and GCP trained Investigators and Clinical Research Co-ordinators




  • Established SOPs for Audio-Video Consent process




  • Separate drug and blood sample storage refrigerators for research




  • Dedicated working area, for storage, archival and Sponsor/Regulatory Audit




  • Assistance for Preparation for Research protocol, Publication or any other Medical Writing




  • Training Internship for Clinical Research Professionals




 


CONTACT US


For more information and further assistance please contact:





  • Dr. Komal Dalal Advisor - Clinical Research





E-mail: drkomal.bhaktivedantamrd@gmail.com





  • Dr. Parag Sarve Asst. Manager- Clinical Research





E-mail: drparag@bhaktivedantahospital.com


 


Medical Research Department


5th and 6th Floor,


Bhaktivedanta Hospital & Research Institute


Mira Road East, Thane - 401107


Phone: 022-2945 2532/2469/2603


HOSPITAL RESEARCH COMMITTEE

Bhaktivedanta Hospital Research Committee is constituted under Dr. Ajay Sankhe – Director, Bhaktivedanta Hospital & Research Institute to supervise the activities of the Medical Research Department. The committee provides administrative approval prior to commencement of a study and oversees administrative aspects including legal agreements, collaborations as well as infrastructure requirements for conduct of a study. Research study is initiated only after approval of both Bhaktivedanta Hospital Research Committee and Ethics Committee of the Hospital.

HOSPITAL ETHICS COMMITTEE

Bhaktivedanta Hospital Ethics Committee reviews the Scientific and Ethical aspects of each research project to safeguard the dignity, rights, safety and wellbeing of all potential research participants. Bhaktivedanta Hospital Ethics Committee (Bhaktivedanta HEC) is registered as Institutional Ethics Committee under Central Drug Standard Control Organization (CDSCO) working under Union Health Ministry (Reg. No.: ECR/396/Inst/MH/2013/RR-16). Bhaktivedanta HEC monitors each ongoing study at intervals, appropriate to the degree of risk to human subjects.


For more details, please contact on 022-29452532 or send an e-mail to bhaktivedantahec@gmail.com


To download Ethics Committee SOP please click the link below


bhaktivedanta-hec_sops_version_05_21_08_17-min.pdf


Rights & Responsibilities of Research Participants


For English: Research Participants Rights Responsibility


For Hindi: Research Participants Rights Responsibility


 


LIST OF BHAKTIVEDANTA HOSPITAL ETHICS COMMITTEE MEMBERS




























































































Name of Members Position on Ethics Committee Designation & Affiliation Qualification
Dr. Raakhi Tripathi Chairperson, External Associate Professor, (Pharmacology) GSMC & KEMH MBBS, MD
Dr. Suraj Bhagde Member Secretary, Clinician, Internal Consultant Ophthalmologist, Bhaktivedanta Hospital & Research Institute MBBS, MS, DNB
Dr. Swapnil Gautam Member, Clinician, Internal Consultant Physician and Intensivist Bhaktivedanta Hospital & Research Institute MBBS, MD, DNB (General Medicine) MRCP
Dr. Ameya Joshi Member, Clinician, Internal Consultant Endocrinologist Bhaktivedanta Hospital & Research Institute MBBS MD (Internal Medicine) DM (Endocrinology)
Dr. Komal Dalal Member, Internal Consultant Accupuncturist, Advisor - Clinical Research Bhaktivedanta Hospital & Research Institute MBBS, PGDCRM
Dr. Sunil Kuyare Member, Basic Medical Scientist, External Assistant Professor, Department of Microbiology H.B.T Medical College and Dr. R. N. Cooper Hospital, Mumbai MBBS, MD, DHA, FME Post Graduate Diploma in Bioethics (PGDBE)
Dr. Anita Ramchandran Member, Basic Medical Scientist, External Assistant Professor, Microbiology LTMMC & GH, Sion, Mumbai MBBS, MD, FME, FAIMER
Mrs. Noopur Desai Member, Representative of NGO, External Social Worker for KATALYST and ISKCON Food Relief Foundation BSc Life Sciences
Mrs. Hetal Varma Member, Social Scientist, Internal Medical Social Worker, Bhaktivedanta Hospital and Research Institute Masters of Social Work
Mr. Anant Singh Member, Legal Expert, External Practicing Advocate at Mumbai Court; Lawyer - Regrace Group of Companies, Mumbai LLM, LLB, Masters of Public Administration
Mrs. Devyani Maheshwari Member, Legal Expert, External - BA, LLB
Mrs. Sarita Gadhari Member, Lay person, External - BA, BEd
Mrs. Meera Singh Member, Lay person, External - BCom

HOSPITAL INITIATED & ACADEMIC RESEARCH

The Medical Research Department conducts multi-speciality Investigator Initiated (Hospital funded) and Academic studies. We provide assistance in study related Documents Preparation, Data Analysis (Statistical work), Project Management, Manuscript Writing and Publications. We are conducting Hospital Initiated & Academic Research studies in the following domains:





  • Spiritual Care




  • Community




  • Ayurveda




  • Nutraceuticals




  • Nursing




  • Medicine




  • Integrated Medicine




CLINICAL TRIALS

We are conducting Clinical Trials in collaboration with more than 25 National/Global Sponsors as well as Clinical Research Organisations in various Multispecialty Clinical Research Projects since 2013. 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. Dedicated team of experienced, GCP trained Investigators, Co-ordinators and QA Manager work together to ensure study Protocol compliance. We are conducting Clinical Trials in the following therapeutics areas:





  • Cardiology




  • Dermatology




  • ENT




  • Endocrinology




  • Gynecology




  • Hematology




  • Medicine




  • Neurology




  • Pulmonary Medicine




  • Urology




  • Rheumatology




  • Oncology




  • Ophthalmology




  • Orthopedics




PUBLICATIONS

 


ORIGINAL ARTICLES


(To read an Original Article, please click on its title.)






























































Sr. No. Title Authors Name of Journal
1 Spiritual Care Therapy on Quality of Life in Cancer Patients and Their Caregivers: A Prospective Non-randomized Single-Cohort Study Dr. Ajay Sankhe, Dr. Komal Dalal, Dr. Vishnu Agarwal, Dr. Parag Sarve Journal of Religion and Health (Springer, Pubmed Index)
2 Evaluation of the effect of Spiritual care on patients with generalized anxiety and depression: a randomized controlled study Dr. Ajay Sankhe, Dr. Komal Dalal, Dr. Devendra Save, Dr. Parag Sarve Psychology, Health and Medicine Journal(PubMed Indexed, Peer review)
3 Evaluation of performance of the Medical Research Department in 'Research naive' non-academic hospital: An audit Mrs. Mukta Kuyare, Dr. Parag Sarve, Dr. Komal Dalal, Dr. Raakhi Tripathi Perspective in Clinical Research (PubMed Index, Peer review)
4 A Comparative Assessment of Hydroxyl and Calcium Ion Diffusion from Calcium Hydroxide Based Intracanal Medicaments in Primary Teeth - An In Vitro Study Dr. Sneha Sreedhar, Dr. Rashmi Nayak BAOJ Dentistry
5 Vitamin D – Is it a neglected analgesic for non-specific musculoskeletal pain? Dr. Pramodini S., Dr Parag Sarve European Journal of Biomedical and Pharmaceutical Sciences (Peer review)
6 Integrated approach in the management of bronchial asthma: A retrospective analysis Dr. Memane, Dr. Sankhe International journal of Ayurveda and Pharmaceutical Research (Peer review)
7 Establishing Institutional Ethics Committees: Challenges and Solutions- a review of the Literature Mrs. Mukta Kuyare, Dr. Santosh Taur, Dr. Urmila Thatte Indian Journal of Medical Ethics (PubMed Index, Peer review)
8 Perceptions and Experiences of Community Members Serving on Institutional Review Boards: A Questionnaire Based Study Mrs. Mukta Kuyare, Dr Marathe, Dr. Urmila Thatte, Dr. Sunil Kuyare (KEM Hospital) HEC Forum International Journal (PubMed Index, Peer review)


 


CASE REPORTS


(To read a Case Study, please click on its title.)






















































































Sr. No. Title Authors Name of Journal
1 Strawberry skull in Edwards syndrome Dr. Umesh Shriniwas Mudaliyar, Dr. Sneha Umesh Mudaliyar The British Institute of Radiology Journal (PubMed Indexed)
2 Chaos syndrome Dr. Umesh Mudaliyar, Dr. Sneha Sreedhar The British Institute of Radiology Journal (PubMed Indexed)
3 A case of intrauterine contraceptive device in peritoneal cavity invading sigmoid colon – A rare entity Dr. B. C. Shah, Dr. Sarang Degloorkar Journal of Case Reports
4 Giant Fibro epithelial Polyp of Vulva – A rarest of its occurrencel Dr. B. C. Shah, Dr. Sarang Degloorkar Mumbai Journal of Case Reports
5 Hyperphosphatemic Tumoral Calcinosis Dr. Umesh Mudaliyar Journal of Case Reports
6 A rare case of left sided acute appendicitis in a patient with mid gut malrotation Dr. B. C. Shah, Dr. Sarang Degloorkar Journal of Case Reports
7 Largest Chondroid Syringoma of the skin: A case report Dr. Vishnu Agarwal Indian Journal of Medical Case Reports
8 Obturator Hernia Causing Intestinal Obstruction Dr. B. C. Shah, Dr. Sarang Degloorkar Journal of Case Reports
9 Volvulus Of Meckels Divetticulum – A Rare Cause Of Intestinal Obstruction In Children Dr. B. C. Shah, Dr. Sarang Degloorkar Journal of Case Reports
10 Leiomyoma Of Testis Dr B. C. Shah, Dr. Sarang Degloorkar Journal of Case Reports
11 Rare Occurrence Of Enterocutaneous Fistulae Following Onlay Mesh Repair For Incisional Hernia: A Case Series Dr. B. C. Shah, Dr. Sarang Degloorkar South American Journal of Surgery
12 Gall stones presenting as left lumbar pain: A rare occurrence Dr. B. C. Shah, Dr. Sarang Degloorkar Journal of Case Reports


 


RESEARCH PAPER/POSTER PRESENTATION AT CONFERENCES
































Sr. No. Title Authors Name of Journal
1 Spirituality and Medicine: An integrated approach to cope up with anxiety and depression among patients and caregivers Dr. Ashok Shetty DERMACON - National Conference of Indian Association of Dermatologist, 2015
2 Reviewing use of deception as Intervention in Clinical Research Mrs. Mukta Kuyare


  • American College of Clinical Pharmacology (ACCPSF2015), San Francisco, USA

  • The Forum for Ethical Review Committees in the Asian and Western Pacific FERCAP - 2015 International Conference at Nagasaki, Japan



3 Community Member Perspective in Institutional Review Board Mrs. Mukta Kuyare The Forum for Ethical Review Committees in the Asian and Western Pacific FERCAP -2015 International Conference at Nagasaki, Japan

NEWS & ACHIEVEMENTS




  • Successful Registration renewal of BhaktiVedanta Hospital Ethics Committee (Institutional Ethics Committee) under Central Drug standard control organization (CDSCO) working under Union Health Ministry, New Delhi (Reg. No.: ECR/396/Inst/MH/2013RR-16, Period: June 2016 to June 2019)


    http://www.cdsco.nic.in/writereaddata/mhBHAKTI-804%20RC.pdf




  • Bhaktivedanta Hospital & Research Institute is the recipient of the prestigious ‘Worldwide Achiever Award 2015 - Best Multispecialty Hospital for Innovation and Research’




  • Hospital is registered under USFDA for conducting Global Clinical Trials – (GUDFA FEI number- 3010542690) in May 2015




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