Human Care Research is an independent clinical research organization located in Mumbai, India that provides a wide range of clinical trial services including project management, clinical operations, preclinical operations, data management, medical writing, and regulatory services. It has a network of qualified principal investigators across India and adheres to ICH/GCP guidelines, Indian GCP, and US FDA regulations. Its goal is to support successful clinical trials and drug development through strict ethics and quality standards.

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.

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.