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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.
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: