Hcr Part1


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HCR contract Research Organization Part1

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Hcr Part1

  1. 1. Human Care Research Clinical Research Consulting & Site Management Organization (SMO) www.humancareresearch.com -- Excellence with Ethics & Quality
  2. 2. <ul><li>Vision: </li></ul><ul><li>“ Dedicated in providing superior clinical research to better the lives of all those we serve with Ethics & Quality.” </li></ul><ul><li>Mission: </li></ul><ul><li>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. </li></ul>
  3. 3. <ul><li>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. </li></ul><ul><li>HCR offers wide range of services to Contract Research Organizations and Pharmaceuticals for clinical trial services. </li></ul><ul><li>HCR, Mumbai (India) based, is a fully integrated research facility with capabilities geared to provide services in all aspects of Clinical Trials. </li></ul><ul><li>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. </li></ul>
  4. 5. <ul><li>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:     </li></ul><ul><li>Project Management </li></ul><ul><li>Clinical Operations – Phase II-IV </li></ul><ul><li>Preclinical Operations – Toxicology /In vitro/In Vivo </li></ul><ul><li>Data Management Services </li></ul><ul><li>Medical Writing & Biostatistics </li></ul><ul><li>BA/ BE Study, First-in-Man Study </li></ul><ul><li>Central Lab Selection & co-ordination </li></ul><ul><li>Corporate Training </li></ul><ul><li>Regulatory Services </li></ul><ul><li>Pharmacovigilance and Safety Assessment </li></ul><ul><li>Patient Recruitment-Healthy volunteers / Patients for CT </li></ul><ul><li>Quality assurance </li></ul><ul><li>Translation of study documentation </li></ul>
  5. 6. <ul><li>Site Feasibility Assessment & PI Selection, PI meeting </li></ul><ul><li>Clinical Research Documents Development: CRF / Protocol / ICF Design </li></ul><ul><li>Site Managements: Site initiation, Monitoring/Medical Monitoring, Site Closeout </li></ul><ul><li>Trial logistics, trial supplies </li></ul><ul><li>Clinical Monitoring of Phase I, II, III, and IV trials. </li></ul><ul><li>Audit of Clinical Trials </li></ul><ul><li>Study Team Training </li></ul><ul><li>Site Infrastructure Provisioning </li></ul><ul><li>IRB/EC Submission/Approval </li></ul><ul><li>DCGI Submission/Approval </li></ul><ul><li>Consulting & Regulatory Support Services </li></ul><ul><li>Documentation with Electronic Data Capture (EDC) expertise </li></ul><ul><li>Help-out for faster patients recruitment </li></ul><ul><li>Obtaining import and export licenses for new molecules/products.   </li></ul>
  6. 7. <ul><li>Clinical Trials Identifications </li></ul><ul><li>Budget and contract preparation and negotiation </li></ul><ul><li>Centralised communication between sites and the sponsor </li></ul><ul><li>Assistance with patient recruitment, including advertising campaigns </li></ul><ul><li>ICH-GCP Education to Clinical research staffs / PI </li></ul><ul><li>Selections of Contract research staff (experienced clinical trial co-ordinators) and recruitments for PI sites </li></ul><ul><li>Developments of SOPs ( Site / trials specifics) </li></ul><ul><li>Site Coordination & Management </li></ul><ul><li>Management of patients recruitments strategies /advertisement campaign </li></ul>
  7. 8. <ul><li>Design course syllabus-Clinical Research </li></ul><ul><li>Conduct Clinical Research (GCP) Training </li></ul><ul><li>Placement services </li></ul><ul><li>Help PhD Student for supply chemicals / products samples </li></ul><ul><li>Research people provide Journals articles </li></ul><ul><li>Corporate Training Services (ICH GCP, CRA/CRC, Site/Investigator) </li></ul><ul><li>Ethical approval for student research </li></ul><ul><li>Arrangement of guest for career guidance </li></ul><ul><li>Arrangement of Industrial Visit for Students </li></ul>
  8. 9. <ul><li>Investigators </li></ul><ul><li>Large No. of specialists in different therapy segments </li></ul><ul><li>Medical Training In English : PG training from Europe/US </li></ul><ul><li>600,000 Eng. Speaking physicians </li></ul><ul><li>Large no. of ICH/GCP compliant Investigators / sites </li></ul><ul><li>Patient population </li></ul><ul><li>Large and diverse patient pool </li></ul><ul><li>Advantage of having 6 out of 7 genetic varieties </li></ul><ul><li>Large pt. pool in acute/chronic disease segment </li></ul><ul><li>Increasing no. of patients in life style disorders segment, HIV, Oncology </li></ul><ul><li>Central lab facilities (Internationally, Nationally accredited). </li></ul><ul><li>Regulatory prospective </li></ul><ul><li>ICH/GCP guidelines implementation. </li></ul><ul><li>USFDA/DCGI/ICMR: Regulatory guidelines and government policies helping clinical research in India. </li></ul>