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 based on 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 Hospital started its clinical research services in 2009. We have completed over 50 trials in various specialties and phases to date. Our team comprises Site Start-up specialists, QA manager and Clinical Research Coordinators (CRCs), headed by Dr. S. K. Raut, Director, Clinical Research.
Noble has the advantage of having efficient PI group Specialties in all major therapeutic areas like Oncology, Gynaecology, Cardiology, ENT, Ophthalmology, Orthopaedics, Dermatology, Gastroenterology, Urology & Nephrology.
The scope of our services includes
- Patient Screening and Recruitment: Our project management and study coordinators provide support to the investigators in the speedy recruitment of patients. A database of all patients admitted in the hospital and those availing out-patient facilities across the 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 ensures that the planning and execution of the clinical trials are smoothly managed from start to finish.
Clinical Research Facilities
- Dedicated space for clinical trials: Noble Hospital Clinical Research Department has a dedicated Space with 1200 sqft 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 a 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.
Noble Hospital Institutional Ethics committee
Noble Hospital Institutional Ethics Committee (IEC) is approved by the Central Drugs Standard Control Organization (DCGI), under the Drugs and Cosmetics (Third Amendment) Rules 2013. Institutional Ethics Committee constituted as per ICH – GCP guidelines & Schedule – Y, has 11 members from various walks of life, with gender balance as per local statutory requirements. IEC meets every once in three months or whenever required and ensures that universal ethical values and international scientific standards are expressed in terms of local community values and customs. It especially has a focus to protect the safety, dignity, rights, and well-being of research participants.
The IEC attempts to ensure the protection of subjects by reviewing research protocols and related materials. The purpose of the IEC is to assure, both in advance and by periodic review, those appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. It promotes fully informed and voluntary participation by prospective subjects and seeks to maximize the safety of subjects. If required we seek expert opinion from various specialty and super specialty from our Hospital.
(DCGI Reg. NO. – ECR/259/Inst/MH/2013)
The Ethics committee 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.
- All Ethics Committee Members undergo a training program to update themselves about the current scenario in Clinical Research Also we send our Principal Investigators for ICH GCP Training programs.