Hcr Part1

Human Care ResearchHuman Care Research

Clinical Research Consulting & Site Clinical Research Consulting & Site Management Organization (SMO)Management Organization (SMO)

www.humancareresearch.com www.humancareresearch.com

-- Excellence with Ethics & Quality-- Excellence with Ethics & Quality

Vision:Vision:

““Dedicated in providing superior clinical research to better the lives of all Dedicated in providing superior clinical research to better the lives of all those we serve with Ethics & Quality.”those we serve with Ethics & Quality.”

Mission: Mission:

To help our customers to achieve their business objective by providing To help our customers to achieve their business objective by providing superior medical research, be innovative , best-in-class consulting, clinical superior medical research, be innovative , best-in-class consulting, clinical research solution and services.research solution and services.

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.

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 Project Management Clinical Operations – Phase II-IVClinical Operations – Phase II-IV Preclinical Operations – Toxicology /In vitro/In VivoPreclinical Operations – Toxicology /In vitro/In Vivo Data Management Services Data Management Services Medical Writing & Biostatistics Medical Writing & Biostatistics BA/ BE Study, First-in-Man StudyBA/ BE Study, First-in-Man Study Central Lab Selection & co-ordination Central Lab Selection & co-ordination Corporate TrainingCorporate Training Regulatory Services Regulatory Services Pharmacovigilance and Safety Assessment Pharmacovigilance and Safety Assessment Patient Recruitment-Healthy volunteers / Patients for CTPatient Recruitment-Healthy volunteers / Patients for CT Quality assurance Quality assurance Translation of study documentationTranslation of study documentation

Site Feasibility Assessment & PI Selection, PI meetingSite Feasibility Assessment & PI Selection, PI meeting Clinical Research Documents Development: CRF / Protocol / ICF DesignClinical Research Documents Development: CRF / Protocol / ICF Design Site Managements: Site initiation, Monitoring/Medical Monitoring, Site Site Managements: Site initiation, Monitoring/Medical Monitoring, Site

Closeout Closeout Trial logistics, trial suppliesTrial logistics, trial supplies Clinical Monitoring of Phase I, II, III, and IV trials.Clinical Monitoring of Phase I, II, III, and IV trials. Audit of Clinical TrialsAudit of Clinical Trials Study Team TrainingStudy Team Training Site Infrastructure ProvisioningSite Infrastructure Provisioning IRB/EC Submission/ApprovalIRB/EC Submission/Approval DCGI Submission/ApprovalDCGI Submission/Approval Consulting & Regulatory Support ServicesConsulting & Regulatory Support Services Documentation with Electronic Data Capture (EDC) expertiseDocumentation with Electronic Data Capture (EDC) expertise Help-out for faster patients recruitmentHelp-out for faster patients recruitment Obtaining import and export licenses for new molecules/products. Obtaining import and export licenses for new molecules/products.  

Clinical Trials IdentificationsClinical Trials Identifications Budget and contract preparation and negotiation Budget and contract preparation and negotiation Centralised communication between sites and the sponsorCentralised communication between sites and the sponsor Assistance with patient recruitment, including advertising campaignsAssistance with patient recruitment, including advertising campaigns ICH-GCP Education to Clinical research staffs / PIICH-GCP Education to Clinical research staffs / PI Selections of Contract research staff (experienced clinical trial co-Selections of Contract research staff (experienced clinical trial co-

ordinators) and recruitments for PI sitesordinators) and recruitments for PI sites Developments of SOPs ( Site / trials specifics)Developments of SOPs ( Site / trials specifics) Site Coordination & Management Site Coordination & Management Management of patients recruitments strategies /advertisement campaignManagement of patients recruitments strategies /advertisement campaign

Design course syllabus-Clinical Research Design course syllabus-Clinical Research Conduct Clinical Research (GCP) TrainingConduct Clinical Research (GCP) Training Placement servicesPlacement services Help PhD Student for supply chemicals / products samples Help PhD Student for supply chemicals / products samples Research people provide Journals articlesResearch people provide Journals articles Corporate Training Services (ICH GCP, CRA/CRC, Site/Investigator) Corporate Training Services (ICH GCP, CRA/CRC, Site/Investigator) Ethical approval for student researchEthical approval for student research Arrangement of guest for career guidanceArrangement of guest for career guidance Arrangement of Industrial Visit for StudentsArrangement of Industrial Visit for Students

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.