Human Care Research Clinical Research Consulting & Site Management Organization (SMO) www.humancareresearch.com -- Excellence with Ethics & Quality
Human Care Research
Clinical Research Consulting & Site
Management Organization (SMO)
www.humancareresearch.com
-- Excellence with Ethics & Quality
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.
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 SERVICES
CLINICAL
CONSULTING
CONTRACT RESEARCH
ORGANIZATION
PRECLINICAL RESERCH
SITE MANAGEMENT ORGANIZATION
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
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.
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
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
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.
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
Mumbai, Navi Mumbai
Thane
Pune
Nashik
Aurangabad
Dhule
Nagpur
Goa
Ahmadabad
Vadodara
Jaipur
Raipur
Mysore
Thiruvananthapuram
Kolkata
Bhopal
Mangalore
Aligarh
Karnal
Chandigarh
Lucknow, Azamgarh, Varanasi.
Surat
Delhi
Chennai
Bangalore
Hyderabad
Our Network in IndiaWe have an expanding network of dedicated, experienced, GCP trained, and
quality conscious investigators throughout India.
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:
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
Decision to place a clinical trial
HCR
Research
Balance
Cost
Speed Quality
Anesthesiology
Cardiovascular Diseases
Critical Care Medicine
Dermatology
Endocrinology
Gastroenterology
Geriatric Medicine
Gynecological Oncology
Oncology
Nephrology
Neurology
Obstetrics & Gynecology
Ophthalmology
Orthopedic Pediatrics
Pulmonary Disease
Urology
Internal Medicine
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
[email protected] , [email protected] ,
www.humancareresearch.com
Site Address:
Human Care research Pvt. Ltd.
Dr. Deshpande’s
ASHIRWAD HOSPITAL
Maratha Section, Near Jijamata Udyan
Ulhasnagar-421004
Dist Thane (Maharashtra) (India)
LALIT GORE