Human Care Research
Clinical Research Consulting & Site
Management Organization (SMO)
-- Excellence with Ethics & Quality
“Dedicated in providing superior clinical research to better the lives of all
those we serve with Ethics & Quality.”
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.
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.
SITE HCR CONTRACT
MANAGEMENT SERVICES RESEARCH
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:
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
Pharmacovigilance and Safety Assessment
Patient Recruitment-Healthy volunteers / Patients for CT
Translation of study documentation
Site Feasibility Assessment & PI Selection, PI meeting
Clinical Research Documents Development: CRF / Protocol / ICF Design
Site Managements: Site initiation, Monitoring/Medical Monitoring, Site
Trial logistics, trial supplies
Clinical Monitoring of Phase I, II, III, and IV trials.
Audit of Clinical Trials
Study Team Training
Site Infrastructure Provisioning
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.
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
Design course syllabus-Clinical Research
Conduct Clinical Research (GCP) Training
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
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
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).
ICH/GCP guidelines implementation.
USFDA/DCGI/ICMR: Regulatory guidelines and government policies helping
clinical research in India.
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
Fully validated 21 CFR Part 11 compliant database
Regulatory compliance at every step
Quick and efficient processes
Investigations & Sample Storage facility
Our Network in India
We have an expanding network of dedicated, experienced, GCP trained, and
quality conscious investigators throughout India.
Mumbai, Navi Mumbai Thiruvananthapuram
Goa Lucknow, Azamgarh, Varanasi.
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.
We provide following type of services:
Toxicities Studies: Acute/ Sub acute/ Chronic / Reproductive Toxicity/ Genotoxicity
Special Toxicity Studies:
Decision to place a clinical trial
Human Care research Pvt. Ltd.
Plot No 201, A wing, Daffodil Apartment,
Near Lal chowki,
Thane (Maharashtra) (India)
email@example.com , firstname.lastname@example.org ,
Human Care research Pvt. Ltd.
Maratha Section, Near Jijamata Udyan
Dist Thane (Maharashtra) (India)