- Phone: 072-1257-09-99
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- savansamravati@gmail.com
Radiant Superspeciality Hospital (RSH)- Clinical Trail Research (CTR)
has been constituted in the year 2018, under the able leadership of Executive Director Dr. Sikandar G. Adwani
The Research Mission of RSH-CTR is to undertake and promote excellence in clinical research and to foster and support patient care and treatment. At RSH-CTR, Pharma-sponsored, Investigator-initiated and Academic research projects provide the foundation for the research activities. These projects are complemented by large organizational projects, population-based epidemiologic studies, community-based intervention programs, multicenter controlled clinical trials, and research training programs.
⦁ Experienced and GCP trained Research Investigators assisted by a dedicated and full time GCP trained Research Team.
⦁ Spacious working area with facilities for storage, audit and archival of research related activities
⦁ Updated SOPs in accordance with national and international regulations.
⦁ Centre for Accident & Emergency
⦁ Centre for Children
⦁ Centre for Diabetes and Obesity
⦁ Centre for Neurosciences
⦁ Centre for Cardiac Sciences
⦁ Children’s Heart Centre
⦁ Critical Care
⦁ Centre for Mother & Child
⦁ Centre for Physical Medicine & Rehabilitation
⦁ Centre for Internal Medicine
⦁ Centre for Gastroenterology
⦁ Set directions, priorities and thrust areas for Research.
⦁ Periodically review the progress of Scientific and Clinical Research Projects.
⦁ Suggest and review Research Proposals within RSH and in collaborations with other National and International Organizations.
⦁ Review sponsored (Pharma Sponsored, Govt Sponsored etc.) Research Proposals for feasibility and conduct at the Institute.
⦁ Coordinate the functioning of committees for research and ethics in RSH
:
Clinical studies helps to bridge research and patient care by evaluating therapies, drugs and diagnostic tools to give way to discoveries that might be of benefit to the human patients in future.
Clinical trials are used to test the safety and effectiveness of drugs and devices. Usually, they are sponsored by pharmaceutical companies and are conducted by research teams that include doctors and other medical professionals. Clinical trials are typically conducted in four phases:
– Phase I is when generally healthy people are given the medication to test if the ingestion of the pill or treatment will have no adverse and/or toxicological effect and that it is absolutely safe to be used in human patients.
– Phases II and III involves deeper evaluation regarding the safety, effectiveness, and dosage of the medication. It’s after these stages that the country drug regulator would approve the drug or device.
– Phase IV examines and conducted to collect more information for previously approved treatments.
All of the phases in clinical trials are governed by strict protocols, and are overseen by many regulatory bodies, from the Drug Controller General of India to Institutional Ethics Committee (DCGI). DCGI are a group of independent medical experts, ethicists, as well as lay person. Researchers periodically report to the IEC regarding entire conduct of the study which includes the tests involved in the study, the results recorded and even the side effects reported. According to the recent regulations, IEC now needs to be accreditated with NABH. (National Accreditation Board for Hospitals
Institutional Ethics Committee is an independent body constituted of medical, non-medical, scientific and non-scientific members whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in the trial by, among other things, reviewing, approving and providing continuing review of trial protocols and amendments.
Timely reviews and safeguarding of high ethical standards formed the basis of the IEC review process which are essential for clinical research including student research, investigator initiated research and multi-centric multinational research.
Name: Dr. Sanket Pande
Gender: Male
Education Qualification: MD (Pediatrics)
Role in IEC: Chairman
Current Organization : Consultant Pediatrician, Hope & Life care Hospital, Amravati
Affiliation (Yes/No): No
Name: Dr. Madhuri Agrawal
Gender: Female
Education Qualification: MD (Pediatrics)
Role in IEC: Member Secretary
Current Organization : Radiant Superspeciality Hospital, Amravati
Affiliation (Yes/No): Yes
Name: Dr. Kishor Bansod
Gender: Male
Education Qualification: MD (Pharmacology)
Role in IEC: Basic Medical Scientist
Current Organization : Bansod Nursing Home, Old bypass road, Dastur Nagar, Amravati
Affiliation (Yes/No): No
Name: Dr. Ganesh Bansod
Gender: Male
Education Qualification: MBBS; MD(internal Medicine)
Role in IEC: Clinician
Current Organization : Gajanan Township No 4, Pote Estate, Near P.R. Pote engineering college, Kathora Road, Amravati
Affiliation (Yes/No): No
Name: Mr. Nilesh Ahuja
Gender: Male
Education Qualification: LLB
Role in IEC: Legal Expert
Current Organization : DEVIKA, beside PratidinAkhbar, Rajapeth, near Ice Factory, Amravati, 444606
Affiliation (Yes/No): No
Name: Dr. Arti Murkey
Gender: Female
Education Qualification: MBBS; DGO
Role in IEC: Clinician
Current Organization : Kabra Hospital, Moti Nagar, Amravati ( Maharashtra) 444606
Affiliation (Yes/No): No
Name: Dr. Anuradha Kakani
Gender: Female
Education Qualification: MD (Obs& Gyn.)
Role in IEC: Clinician
Current Organization : Radiant Superspeciality Hospital, Amravati
Affiliation (Yes/No): Yes
Name: Ms. Sushama Kingaonkar
Gender: Female
Education Qualification: MSW
Role in IEC: Social Scientist
Current Organization : C/o S.M Watkar, Chabda Layout, LIC colony, Amravati
Affiliation (Yes/No): No
Name: Mrs. Anita Patil
Gender: Female
Education Qualification: BA, MA, M.Lib
Role in IEC: Lay Person
Current Organization : c/o Dream Signature, Congress Nagar, AV Block no 603, Amravati, Maharashtra
Affiliation (Yes/No): No
Name: Dr.Saurabh Ambadekar
Gender: Male
Education Qualification: MBBS; MD (Resp. Medicine)
Role in IEC: Clinician
Current Organization : Mahalakshmi Colony Near Balaji Nagar, Amravati.(Maharashtra)
Affiliation (Yes/No): No
⦁ Right to voluntary participation in research study.
⦁ Right to know about Institutional Ethics Committee and its responsibilities towards protecting patients rights, safety and well-being involved in a research project and to provide public assurance of that protection
⦁ Right to information about Research Study in an understandable language.
⦁ Right to informed consent and if necessary audio-video consenting before participation in any Research Study.
⦁ Right to refusal of participation or withdrawal of participation at any point in the study without disclosing any reason.
⦁ Right to receive quality healthcare in a safe, clean environment without discrimination because of race, age, color, religion, nationality, culture, ethnicity, language, disability, sex or manner of payment.
⦁ Right to be treated with dignity, respect and courtesy in a non-judgmental and non-threatening manner.
⦁ Right to information regarding investigational product, duration of study, treatment option available as per standard of care, anticipated expenditure, information on medical management of any injury and compensation in case of any study related injury or death or any compensation provided for participation in an understandable language.
⦁ Right to be informed of the risks, benefits and alternatives of proposed treatment
⦁ Right to privacy and confidentiality.
⦁ Right to be informed on how to voice a complaint to express concerns, violation of your rights and/or grievance and seek redressal
⦁ Right to participation in research and innovative therapies.
⦁ Right to consent for diagnostic and therapeutic procedures.
⦁ Right to access clinical records
⦁ Right to get 24 hours emergency contact details of Research doctor
⦁ Right to get contact details of Chairperson and Member Secretary of Institutional Ethics Committee.
Responsibilities & role of Research Participant:
⦁ To provide correct and complete demographic information including full name, age, address, telephone number and e-mail ID (if available)
⦁ To be compliant with research protocol and procedures
⦁ To ask question when he/she does not understand what the doctors, research study team, or other healthcare team members tells about diagnosis or treatment
⦁ To inform your research study doctor and research study team, immediately in case of any injury or development of any new medical conditions
⦁ Not to take any medications without the knowledge of research doctor and research study team
⦁ To disclose to doctors and research study team if currently part of any other Clinical Trial or had participated in any other Clinical Trial in last one year
⦁ Provide complete and accurate information about your health including your previous medical history, and all the medications that you are presently taking including alternative treatments like Ayurveda, Homoeopathy, Unani or herbal medications, all records of previous investigations and treatment and of allergic reactions, especially sensitivity to any drug
⦁ To follow instructions, advice and restrictions regarding treatment plan and visit schedules
⦁ To treat hospital staff and study team with courtesy
Investigator: Dr.Sikandar G. Adwani
Speciality: Neurology
Study Name: A Double Blind,Double-Dummy Randomized Prospective, Two Arm, Parallel, Multicenter Phase VI Clinical Trail To Evaluate and Safety Of Gabapain NT (Fixed-Dose Combinatation of Gabapain And Nortriptyline) In Comparison With Gabapain In Patients With Neuropathic Pain”
Company Name: LAMBDA THERAPEUTIC RESEARCH LTD
Phase: IV
Type: National
Status: Completed
Investigator: Dr.Anand B. Kakani
Speciality: Neurosurgery
Study Name: A Prospective, Multi-Centric, Randomized, Double-Blind, Parallel, Phase-III Study To Assess Efficiency Of Pmz-2010 As A Resuscitative Agent For Hypovolemic Shock To Be Used As An Adjuvant To Standard Shock Treatment
Company Name: PHARMAZZ INDIA PRIVATE LIMITED
Phase: III
Type: National
Status: Completed
Investigator: Dr.Sikandar G. Adwani
Speciality: Neurology
Study Name: A Prospective, Multi-Centric, Randomized, Double-Blind, Parallel, Phase-III Study to Assess Efficiency of Pmz-1620 Along with Standard Treatment in Patients of Acute Ischemic Stroke.
Company Name: PHARMAZZ INDIA PRIVATE LIMITED
Phase: III
Type: National
Status: Completed
Investigator: Dr.Sikandar G. Adwani
Speciality: Neurology
Study Name: A prospective, multicentric, randomized, double-blind, parallel, phase IV study to assess the safety and efficacy of TycamzziTM (sovateltide) in patients with acute cerebral ischemic Stroke.
Company Name: PHARMAZZ INDIA PRIVATE LIMITED
Phase: IV
Type: National
Status: Completed
Investigator: Dr.Ganesh Bansod
Speciality: Physician
Study Name: “A Phase 2, Randomized, Double Blind, Multicenter Study to Evaluate the Immunogenicity, Reactogenicity and Safety of an Intranasal Adenoviral vector COVID-19 vaccine (BBV154) in Healthy Volunteers.”
Company Name: BHARAT BIOTECH PVT.LTD.
Phase: II
Type: National
Status: Completed
Investigator: Dr.Anuradha Kakani
Speciality: Gynaecologist
Study Name: : “A real-world prospective study to evaluate the geographical distribution of prevalence, sensitization rate, and utilization of prophylactic treatment of Rh-negative women in India.”
Company Name: BHARAT SERUM AND VACCINE LIMITED
Phase: OBSERVATIONAL
Type: National
Status: Ongoing
Investigator: Dr.Ganesh Bansod
Speciality: Physician
Study Name: : A PHASE II/III, MULTICENTER, DOUBLE BLIND, RANDOMIZED STUDY OF SII YELLOW FEVER VACCINE TO COMPARE SAFETY AND IMMUNOGENICITY WITH STAMARIL® IN ADULTS
Company Name: SERUM INSTITUTE OF INDIA PVT.LTD.
Phase: II/III
Type: National
Status: Ongoing
Investigator: Dr.Ganesh Bansod
Speciality: Physician
Study Name: A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicentric Study of Dengue Monoclonal Antibody in Children ≥ 5 Years and Adults with Dengue
Company Name: SERUM INSTITUTE OF INDIA PVT.LTD.
Phase: III
Type: National
Status: Ongoing
Welcome to Radiant Super Speciality Hospital with Rehabilitation Center, where compassionate care meets advanced medical expertise. We are dedicated to providing exceptional healthcare services with a focus on holistic healing and personalized patient care.