Hcr Bussiness 12

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Hcr Bussiness 12

  1. 1. Human Care Research Clinical Research Consulting & Site Management Organization (SMO) -- Excellence with Ethics & Quality www.humancareresearch.com
  2. 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. 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. 4. CLINICAL CONSULTING SITE HCR CONTRACT MANAGEMENT SERVICES RESEARCH ORGANIZATION ORGANIZATION PRECLINICAL RESERCH
  5. 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. 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. 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. 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. 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.
  10. 10.  GCP trained Principal Investigator bank and Research Network  Collaboration with Hospitals: Good quality infrastructure  Patient Pool: Trial patients with own healthy volunteer database  Integrated Approach & Expertise  Qualified and skilled professionals  Time and cost effectiveness  Quality management system  Data confidentiality  Fully validated 21 CFR Part 11 compliant database  Regulatory compliance at every step  Quality deliverables  Quick and efficient processes  Investigations & Sample Storage facility
  11. 11. Our Network in India We have an expanding network of dedicated, experienced, GCP trained, and quality conscious investigators throughout India.  Mumbai, Navi Mumbai  Thiruvananthapuram  Thane  Kolkata  Pune  Bhopal  Nashik  Mangalore  Aurangabad  Aligarh  Dhule  Karnal  Nagpur  Chandigarh  Goa  Lucknow, Azamgarh, Varanasi.  Ahmadabad  Surat  Vadodara  Delhi  Jaipur  Chennai  Raipur  Bangalore  Mysore  Hyderabad
  12. 12.  Wet/Dry granulation up to 5 kg batch size.  Drug layering and/or polymer coating of multiparticulates (Pellets)- Up to 1 kg batch.  Pelletization using extruder spheronizer- Upto 5 kg batch size.  Tablet compression upto 5-10 kg batch.  Qualty control tests for tablets (Precompression/ postcompression)  Stability testing as per ICH guidelines.  Formulation analysis using HPLC.  Spray drying of material- upto 1 kg batch size.  Quality control testing of packaging materials.  Development of nanoparticles using high pressure homogenizer.  Formulation & evaluation of semisolid dosage forms.
  13. 13. We provide following type of services:  Anti-inflammatory  Anti-arthritic  Anti-fertility  Anti asthmatic  Immunomodulator  Kidney stone  Anti-hypertensive  Anti-diabetic  Neuropathic pain  Behavioral studies  Toxicities Studies: Acute/ Sub acute/ Chronic / Reproductive Toxicity/ Genotoxicity  Special Toxicity Studies:
  14. 14. Decision to place a clinical trial Cost HCR Research Balance Speed Quality 14
  15. 15.  Anesthesiology  Oncology  Cardiovascular Diseases  Nephrology  Critical Care Medicine  Neurology  Obstetrics & Gynecology  Dermatology  Ophthalmology  Endocrinology  Orthopedic Pediatrics  Gastroenterology  Pulmonary Disease  Geriatric Medicine  Urology  Gynecological Oncology  Internal Medicine
  16. 16. Office Address: LALIT GORE Human Care research Pvt. Ltd. Plot No 201, A wing, Daffodil Apartment, Near Lal chowki, Kalyan (w)-421301 Thane (Maharashtra) (India) : 9271250403/9867929416/9833508963  lalit@humancareresearch.com , bd@humancareresearch.com , cra_lalit@rediffmail.com www.humancareresearch.com
  17. 17. Site Address: Human Care research Pvt. Ltd. Dr. Deshpande’s ASHIRWAD HOSPITAL Maratha Section, Near Jijamata Udyan Ulhasnagar-421004 Dist Thane (Maharashtra) (India)
  18. 18. LALIT GORE

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