KPS Clinical Services (KPSCS) is set up by the RAHE Group of Organizations, with an aim to become one of the India's leading research-based Contract Research Organization (CRO). Our commitment is to improve the quality of human life & to provide world class clinical research services to pharmaceutical, biotechnology, medical device companies, academic and government organizations. We wish to focus on the prevailing issues in clinical research & give their solutions with a fresh and rational approach. In this endeavor, we have successfully established a team of highly qualified and experienced multi-disciplinary GCP trained personnel. The services provided by KPSCS are knowledge-driven and based on the understanding of the pharmacology and molecular basis of disease. We believe in providing quality services & we prioritize customer relationships.

1. KPS CLINICAL SERVICES PVT. LTD.
(Contract Research Organization)
KPS
Clinical Services
Bestowing Research to Life
www.kpsclinicalservices.com

2. 2
Together Everyone Achieves More
ORGANOGRAM
Managing Director
CEO & Director
Clinical
Operation
Project
Manager
Deputy
Manager
Clinical
Trial Lead
Senior
CRA
CRA
CTA Trainee
Trainee Trainee Trainee Trainee Trainee Trainee Trainee Trainee
Manager
Assistant
Manager
Sr.
Executive
Executive Executive Executive Executive Executive Executive Executive
Assistant
Manager
Sr.
Executive
Assistant
Manager
Senior
Medical
Writer
Medical
Writer
Assistant
Manager
Sr.
Executive
Sr.
Executive
Sr.
Executive
Sr.
Executive
Sr.
Executive
Assistant
Manager
Admin
Officer
IT
Officer
Assistant
Manager
Manager Manager Manager Manager Manager Manager Manager Outsourcing
Quality
Assurance
Medical
Writing
Buissness
Development
Human
Resource
Admistration IT Legal
Ancillary
Services
Drug
Regulatory
Affairs
ACCREDITATION
We are an ISO 9001:2008 certified company■■
Our BA/BE Centre Inspected and Approved by DCGI■■

3. KPS Clinical Services (KPSCS) is set up by the
RAHE Group, with an aim to become one of the
India's leading research-based Contract Research
Organization (CRO). Our commitment is to improve
the quality of human life & to provide world class
clinical research services to pharmaceutical,
biotechnology, medical device companies, academic
and government organizations.
We wish to focus on the prevailing issues in
clinical research & give their solutions with a fresh
and rational approach. In this endeavor, we have
successfully established a team of highly qualified
and experienced multi-disciplinary GCP trained
personnel. The services provided by KPSCS are
knowledge-driven and based on the understanding
of the pharmacology and molecular basis of disease.
We believe in providing quality services & we prioritize
customer relationships.
ABOUT US
Our vision is to become leading drug development
solution provider by delivering apposite services to
the global healthcare industry.
We believe in our values & have established
competency:
To provide a nurturing work culture that stimulates■■
professional excellence through training.
To achieve authorization with accountability and■■
recognition.
To provide a fair return on investment to KPSCS’s■■
investors by driving exponential growth.
To enable delivery of new medicines, while■■
maintaining the most eminent ethical measures
and be a creditworthy corporate national.
VISION
MISSION
Innovation Excellence
Service Excellence Trustworthiness
Continuous Learning Integrity
Community Responsibility Compassion
Quality Work Environment
VALUES
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4. Services
KPSCS staff comprise of highly qualified and
experienced professionals who manage all aspects
of Phase I to Phase IV studies including:
Development of essential clinical trial documents►►
(Protocol, ICD, CRF and Investigator Brochure).
Feasibility of clinical trial studies.►►
Investigator site selection and management.►►
Monitoring and audit of clinical trial site.►►
Clinical trial material logistics and management.►►
Analysing and preparation of clinical study►►
reports.
Responding to regulatory agency’s request for►►
information pertaining to product safety.
DIVISION OF CLINICAL TRIAL EXECUTION
DIVISION OF BIOEQUIVALENCE STUDY CENTER
KPS Clinical Services Pvt. Ltd. has been established own 32-beded
Bioavailablity / Bioequivalence study center in the campus of RV
Northland Institute, Greater Noida.
MAJOR CLIENTS
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5. Services
KPSCS provides regulatory affairs consultancy
tailored to meet client’s specific needs. Client’s data
security and confidentiality is assured to the highest
level.
Ourregulatoryteamhavesignificantglobal experience
in development of Dossiers, Drug Master File (DMF),
and Common Technical Document (CTD).
We provide services from submission to final approval
of regulatory documents at the office of DCG(I), FDA
Bhawan, New Delhi.
We facilitate the guidelines for getting approval /
N.O.C. for following applications:
Bulk Drugs■■
Finished Formulations■■
Medical Devices■■
Vaccines■■
In short, we serve the entire spectrum of regulatory
needs for our clients, based on experience and
knowledge.
DIVISION OF REGULATORY AFFAIRS
DIVISION OF TDM & CLINICAL DATA MANAGEMENT
At KPSCS, we ensure that timelines are met and
quality is maintained. Responsibilities, processes
and expectations are clearly defined at an early stage
for a smooth Therapeutic Drug Monitoring & Clinical
Data management execution.
KPSCS offers services for management and
execution of Therapeutic Drug Monitoring & Clinical
Data Management from single center to multi-centeric
studies in a variety of therapeutic areas.
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6. Services
DIVISION OF MEDICAL WRITING & TRANSLATION
KPSCS provides a wide variety of Post-Marketing
Surveillance services that help the sponsors in
collecting, comparing, processing, tracking, and
reporting the possible adverse events to determine
safety of products. Generally, post marketing
surveillance is done in the Phase-IV of the clinical
trial.
Call Centre services to sort and compile adverse►►
event data
Literature search►►
Data processing and reporting to regulatory►►
authorities
Periodic Safety Update Reports (Preparation of►►
PSURs)
Preparation of Individual Case Safety Reports►►
(ICSR)
DIVISION OF POST MARKETING SURVEILLANCE
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KPSCS offering all medical writing services from
Phase I to IV clinical studies. Our medical writing team
comprises of physician and pharmacologists who
have experience in developing documents in various
therapeutic areas such as Oncology, Cardiology,
Ophthalmology, Diabetolgy, Dental Science,
Neuropsychiatry, Respiratory Disorders, Infectious
Diseases, Dermatology, Hematology, Nephrology,
Cosmetology, Ophthalmology, Antimicrobiological
Agents and Herbal Drugs.
Ourteamhaveexpertiseinscientificwriting,abstracts,
posters, manuscripts and SOPs development.
Documents are prepared strictly in accordance with
ICH/EU/US guidelines and regulations.
The medical writing group has access to excellent
translating services ranging from patient information
sheet, Patient Diaries, ICD, CRF, Product Labels,
Pharmacology Reports, Toxicology reports, Clinical
Study Reports (CSR) and Investigator Brochures.
We are providing translation services in 70+
languages.

7. Services
DIVISION OF TOXICOLOGICAL STUDIES
KPSCS provides pre-clinical laboratory research
services supported by state of the art facilities
worldwide. we can conduct individual studies to
customer specification and also provide goal driven,
consultative study design and execution.
KPSCS conducts research in niche areas of
toxicology such as:
System toxicology & Health risk assessment■■
Nanotherapeutics & nanomaterial toxicology■■
Environmental toxicology■■
Food, Drug & Chemical toxicology■■
KPSCS offering their services to the pharmaceutical,
biotech, medical device, agrochemical or chemical
industries as well as Universities, Government and
other research organizations.
KPSCS has a rich experience in performing Pre-clinical
studies with expertise ranging from acute studies to
more complicated multiple phased studies.
Acute/subacute toxicology studies■■
Chronic toxicology studies■■
Allergic Sensitization■■
Carcinogenic and Mutagenic■■
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8. Services
Animal Facility performs in-vivo tests for quality control
evaluation of biologicals. The Facility ensures timely
availability of lab animals for various in vivo tests by
planned breeding program or by procuring animals
from other CPCSEA registered sources. Animal
Facility ensures high quality animal husbandry and
care that meets the requirements of animal welfare
regulations and guidelines provided by CPCSEA.
Regular Institutional Animal Ethics Committee (IAEC)
meetings are held to obtain ethical clearance for use
of animals in QC testing.
Currently, the following animal strains are
maintained
Mice■■
Rats■■
Rabbits■■
Guinea Pigs■■
ANIMAL HOUSE
MAJOR AREAS FOR TOXICOLOGICAL STUDIES
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Medical devices (Syringes, Catheters, Blood transfusion►►
sets, Dialysis units, Gloves, Sutures etc.).
Genetically Modified crops and Genetically modified►►
organisms.
Contraceptives (Copper T, Tubal rings, Condoms etc.).►►
Herbal formulations and Ayurvedic drugs.►►
Bulk Drugs and Pharmaceuticals.►►
Dyes and Dye intermediates.►►
Cosmetics.►►

9. Services
OTHER SERVICES
Our toxicology laboratory is well equipped with
wide range of instruments for various Biochemical,
Histopathological and Haematological investigation:
Haematology Analyzer►►
Biochemistry Analyzer►►
Various microscopes including inverted►►
microscope
UV/Visible Spectrophotometer►►
Urine Analyzer►►
CO►► 2
Incubator
Automatic Tissue Processor►►
Deep freezer►►
Microtome►►
Centerifuge►►
HPLC►►
Post Marketing Surveillance►►
Safety Assesment Studies►►
Food Suppliment Assesment►►
Health Survey►►
INSTRUMENTS
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Instrumentation Laboratory provides the most
comprehensiveandvaluablesolutionsforyourtesting
needs. Our technology is revolutionizing whole blood
and hemostasis testing. Discover how our laboratory
and point-of-care instruments, assays and reagents
are setting the pace - with more capabilities, more
end-to-end automation and more convenience -
saving time and helping deliver the best possible
patient care. Our facilities comprises of:
Hemostasis Diagnostics■■
Critical Care Diagnostics■■
Clinical Chemistry■■
Accuracy, Intelligence, Speed, Simplicity

10. DIVISION OF bioequivalence
Clinical Pharmacology Unit (CPU)
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32 bed Volunteer Housing Unit Intensive Care Unit Volunteer Counselling Unit
Mess AreaSample Processing Unit Subject Screening Unit
Phlebotomist AreaQuality Assurance Bio Analytical Unit

11. We are in “VOLVO - AGE”. Everywhere healthcare facilities are playing a predominant role in providing
appropriate platform to take off and reach the dream world of health and wellness. At KPS Clinical Services
Pvt. Ltd., we provide variety of services for pre-clinical, BA/BE, clinical study conduct and thier management
and regulatory affairs at global level.
KPS Clinical Services is a pioneer in the concept to develop a way of cost effective execution of various
Research Projects to Pharmaceutical, Biotechnological, Medical Device Companies including Academic and
Government Organizations.
We believe in applying innovative technologies and therapeutic expertise with a commitment to enhance
quality of life to meet our corporate ethics. Our strategic hierarchy aims in maximizing return of our sponsors
on investment and accelerate the delivery of safe and effective therapeutics to patients.
We wish to focus on the prevailing issues in clinical research and works to provide their solutions with a fresh
and rational approach. In this endeavor, we have been successfully established a team of highly qualified and
experienced multi-disciplinary GCP trained personnel.
The services provided by KPS Clinical Services are knowledge-driven and based on the understanding of the
pharmacology and molecular basis of disease. As a result of our tireless efforts in the past and through the
future, we are continuously developing and moulding our strength to deliver best services to our client.
Thanking You
Best Regards,
Mukesh Kumar
CEO & Director- Clinical Operations
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12. KPS CLINICAL SERVICES PVT. LTD.
S-203/204, II Floor, Meridian View Plaza, Alpha Commercial Belt, Alpha-I,
Greater Noida (NCR), G.B. Nagar, U.P. (India)- 201306
Ph. 0120-4231720 / 21 Fax: 0120-4213840
Email: contact@kpsclin.com Web: www.kpsclin.com, www.kpsclinicalservices.com
KPS
ClinicalServices
Bestowing Research to Life