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Published

HCR contract Research Organization Part1

HCR contract Research Organization Part1

Published in Health & Medicine
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Transcript

  • 1. Human Care Research Clinical Research Consulting & Site Management Organization (SMO) www.humancareresearch.com -- Excellence with Ethics & Quality
  • 2.
    • Vision:
    • “ Dedicated in providing superior clinical research to better the lives of all those we serve with Ethics & Quality.”
    • Mission:
    • To help our customers to achieve their business objective by providing superior medical research, be innovative , best-in-class consulting, clinical research solution and services.
  • 3.
    • Human Care Research is an independent consultant & a Site Management Organization, created with passion whose sole purpose is to support a successful outcome of clinical trials and to provide drug Development which include pre-clinical, clinical research and Regulatory services support to the Pharmaceutical, Biotechnology, Medical Device Industry and Clinical site.
    • HCR offers wide range of services to Contract Research Organizations and Pharmaceuticals for clinical trial services.
    • HCR, Mumbai (India) based, is a fully integrated research facility with capabilities geared to provide services in all aspects of Clinical Trials.
    • HCR work with a network of qualified and experienced Principal Investigators across India to provide safe, thorough and cost effective management of clinical programs and business development consulting through strict adherence to ICH/GCP guidelines, the Indian GCP, schedule Y and US FDA regulations.
  • 4.  
  • 5.
    • HCR offers a complete spectrum of preclinical and clinical research services. We are as comfortable offering individual service components or executing a complete process. Our services includes:    
    • Project Management
    • Clinical Operations – Phase II-IV
    • Preclinical Operations – Toxicology /In vitro/In Vivo
    • Data Management Services
    • Medical Writing & Biostatistics
    • BA/ BE Study, First-in-Man Study
    • Central Lab Selection & co-ordination
    • Corporate Training
    • Regulatory Services
    • Pharmacovigilance and Safety Assessment
    • Patient Recruitment-Healthy volunteers / Patients for CT
    • Quality assurance
    • Translation of study documentation
  • 6.
    • Site Feasibility Assessment & PI Selection, PI meeting
    • Clinical Research Documents Development: CRF / Protocol / ICF Design
    • Site Managements: Site initiation, Monitoring/Medical Monitoring, Site Closeout
    • Trial logistics, trial supplies
    • Clinical Monitoring of Phase I, II, III, and IV trials.
    • Audit of Clinical Trials
    • Study Team Training
    • Site Infrastructure Provisioning
    • IRB/EC Submission/Approval
    • DCGI Submission/Approval
    • Consulting & Regulatory Support Services
    • Documentation with Electronic Data Capture (EDC) expertise
    • Help-out for faster patients recruitment
    • Obtaining import and export licenses for new molecules/products.  
  • 7.
    • Clinical Trials Identifications
    • Budget and contract preparation and negotiation
    • Centralised communication between sites and the sponsor
    • Assistance with patient recruitment, including advertising campaigns
    • ICH-GCP Education to Clinical research staffs / PI
    • Selections of Contract research staff (experienced clinical trial co-ordinators) and recruitments for PI sites
    • Developments of SOPs ( Site / trials specifics)
    • Site Coordination & Management
    • Management of patients recruitments strategies /advertisement campaign
  • 8.
    • Design course syllabus-Clinical Research
    • Conduct Clinical Research (GCP) Training
    • Placement services
    • Help PhD Student for supply chemicals / products samples
    • Research people provide Journals articles
    • Corporate Training Services (ICH GCP, CRA/CRC, Site/Investigator)
    • Ethical approval for student research
    • Arrangement of guest for career guidance
    • Arrangement of Industrial Visit for Students
  • 9.
    • Investigators
    • Large No. of specialists in different therapy segments
    • Medical Training In English : PG training from Europe/US
    • 600,000 Eng. Speaking physicians
    • Large no. of ICH/GCP compliant Investigators / sites
    • Patient population
    • Large and diverse patient pool
    • Advantage of having 6 out of 7 genetic varieties
    • Large pt. pool in acute/chronic disease segment
    • Increasing no. of patients in life style disorders segment, HIV, Oncology
    • Central lab facilities (Internationally, Nationally accredited).
    • Regulatory prospective
    • ICH/GCP guidelines implementation.
    • USFDA/DCGI/ICMR: Regulatory guidelines and government policies helping clinical research in India.