Clinical Research

Clinical Research:
Noble Hospital is a multispecialty 250 bed private hospital, providing advanced diagnostic and therapeutic services in all major indications, and easily approachable by the patients from the main city and periphery, this results in a good amount of patient pool. Noble Hospital provides clinical research services for pharmaceutical and biotechnology product development from Phase I to Phase IV. Clinical trials must be scientifically conducted using appropriate methods on the basis of strict observance of Good Clinical Practice and ethical considerations. This requirement places an increasingly heavy administrative burden on the medical institutions that perform clinical trials. A separate dedicated clinical research facility

compliments the work of the investigators by providing them vital administrative and infrastructural support. Noble has a advantage of having efficient PI group in all major therapeutic areas like Oncology, Gynecology, Cardiology, ENT, Ophthalmology, Orthopedics, Dermatology, Gastroenterology, Urology & Nephrology. To mention a few of these, we are glad to have studies running under Dr. D. N Mane (M.D Med), Dr. D.N Hambire (M.D Med), Dr. Shripad Pujari (Neurologist), Dr. Minish Jain(Oncologist), Dr. Padmaj Kulkarni (Oncologist), Dr. Prasad Shah (Cardiologist), Dr. Mini Salunkhe (Gyn/Obs), Dr. Abhay Sadre (Nephrologist), Dr. R.K Shimpi(Urologist), Dr. Sanjay Salunkhe(Gastroenterologist), Dr. S.K Raut (Industrial Physician). All clinical trials are commonly divided into 4 phases. The drug will be approved for use in the general population if it passes through phase 1, 2 & 3. Phase 1 : In this phase a small group of healthy human volunteers are selected. Here, the safety of the drug is monitored closely to determine its side effects. Phase 2 : Trials are done on a group of patients and are designed to assess the activity of the therapy. This phase is safer than phase 1 trials. Phase 2 trials are designed to study the efficacy. Phase 3 : Studies in this phase assess the value of the test drug in a larger group of patients against an approved drug or therapy. Phase 4 : Studies are undertaken by the sponsor company for competitive or other reasons (Example: the drug may not have been tested in certain population groups such as pregnant woman, or it could be tested for interaction with other drugs, etc).

These trials involve the post-launch safety surveillance of a drug to detect longterm adverse effects over larger patient population.

The scope of our services include:

Patient Screening and Recruitment Our project management and study co-ordinators provide support to the investigators in speedy recruitment of patients. A database of all patients admitted in the hospital and those availing out-patient facilities across therapeutic area is maintained to aid in recruitment. This ensures that patients from various ethnic backgrounds and demographics are considered for the trial. Clinical Operations and Project Management Our full time staff of study co-ordinators ensure that planning and execution of the clinical trials is smoothly managed from start to finish.

Clinical Research Facility:

Dedicated space for clinical trials: Noble Hospital Clinical Research Department has a dedicated Space with 1200 sq ft space within the hospital premises exclusively for conducting clinical trials. This includes clinics for consultants to see patients, sample collection room, data entry room, drug storage, conference hall and training hall facilities. State of the art drug storage: A separate fully automated temperature controlled drug storage area for storage of the investigational product. Separate area for archival: A separate fire and water resistant area has been made for archival of study documents. IT infrastructure: Noble Hospital Clinical Research Department has a full scale IT infrastructure with computers connected by LAN with broadband connection to enable study coordinators to handle the data entry and data management requirements.

Research Laboratory

We provide laboratory services for those sponsors who are interested in local labs instead of central labs. Independent, active Ethics committee Noble Hospital Institutional Ethics Committee is independent Ethics Committee of 11 members who are trained in ICH GCP. They have been appointed as per ICH GCP guidelines. They include 5 doctors, a Pharmacologist, a lawyer, a layperson, a lady, a basic scientist and a social worker. The EC is setup to ensure that the research protocols carried out: Are conducted according to the parameters of ICH GCP as well as local regulatory requirements. Do not compromise the safety, rights and well being of the patients participating in the research study. Are conducted under the supervision of medical persons with the required experience/ expertise. Include solely patients who, through their legally acceptable representative have given informed consent for participation in the research study. The Committee can also be called upon to solve the ethical issues of the Noble Hospital on request.

Ethics committee
The Ethics committee meets every fourth Wednesday of the month. It requires 11 sets of the following documents at least 2 weeks prior to the meeting for approval: Curriculum Vitae of Investigators Brief description of proposal/summary Copy of the Protocol/Project and questionnaire (if any) Investigators Brochure Copy of Patient information sheet & Consent form in local language Copy of Advertisements/Information brochures DCGI/DBT/BARC clearance if obtained Copy of Insurance Policy Copy of Clinical trial agreement Copy of IEC proforma Copy of PI undertaking Copy of Case Report Form

For more information, visit http://www.noblehospitalspune.com