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1. Human Care Research
Clinical Research Consulting & Site
Management Organization (SMO)
-- Excellence with Ethics & Quality
www.humancareresearch.com

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.

4. CLINICAL
CONSULTING
SITE HCR CONTRACT
MANAGEMENT SERVICES RESEARCH
ORGANIZATION ORGANIZATION
PRECLINICAL
RESERCH

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.

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. 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.  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. 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
Cost
HCR
Research
Balance
Speed Quality
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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. 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. Site Address:
Human Care research Pvt. Ltd.
Dr. Deshpande’s
ASHIRWAD HOSPITAL
Maratha Section, Near Jijamata Udyan
Ulhasnagar-421004
Dist Thane (Maharashtra) (India)

18. LALIT GORE