Genelife Clinical Research is a technologically advanced CRO that aims to reduce drug development timelines through high quality services. It provides comprehensive clinical trial services from early phase to late phase trials across multiple therapeutic areas globally. Genelife utilizes experienced professionals and innovative tools to efficiently manage projects and ensure quality and regulatory compliance. Its goal is to become the most respected partner in providing product development and meeting unmet clinical research needs.

1. Genelife Clinical Research Pvt. Ltd.
Your Trustworthy Partner in Product Development

2. “Our Belief and Vision define our Success”
Genelife Clinical Research was founded in 2010 with a belief to
succeed in creating a delivery channel which will be able to
reduce the timeline of Drug Development process with highest
possible quality.
Our commitment drives us to carry out the necessary actions to
achieve our objectives successfully. Our aim is to provide the best
service to our clients through the excellence of our work. This
demanding level of professionalism gives belief and security to
our clients.
Quality is base of our growth and to sustain this growth we have
inculcated this as our responsibility of daily work.
Values - Honesty, Morality and Transparency
unbiased and up-front service to our clients and associates.

3. Mission:
To be the preferred partner to our Sponsors in providing complete
solution to product development with unique hallmarks of Quality
and Innovation in the process of integrating and streamlining the
development.
Vision:
To be the most respected partner in providing product
development and unmet clinical research requirements.
Business Goals & Objectives:
To become the world's leading knowledge-driven service provider
for our all Clinical Trial Participants.
“People may forget how fast you did a job –
but they remember how well you did it”
- Famous Quote

4. Genelife is a technologically advanced CRO with experienced
professionals who apply innovative tools and processes to their
clinical development research. We are one of the fastest growing
Contract Research Organization (CRO) providing comprehensive
clinical trials services to the pharmaceutical, biotech, and medical
device industries over a wide range of therapeutic areas. Genelife
is an initiative to provide trust based strategic partnership with
sponsors. Genelife holds to the principle that defensible study
design, reliable data, and thorough analyses are the key
components of a successful product development program.
Genelife’s ability to deliver is demonstrated by the company’s
growth from a small organization to a respected midsize CRO.
Our
APPROACH

5. Services
PLANNING REGULATORY STATISTICAL INPUT
INVESTIGATOR SELECTION MEDICAL WRITING MEDICAL COMMUNITY
ASSESSMENT OPERATION PROJECT EXECUTION
CONTROL REPORTING
QUALITY DATA FAST RECRUITMENT BIGGER MARKET
COST EFFECTIVE LOW RISK
Early Phase Research (Phase I-II)
Genelife Clinical Research believes that a successful trial begins
good site selection to achieve maximum enrollment. Genelife
utilizes experienced project managers and site startup manager
to assist in the recruitment of key investigators for the complex
programs launched in the early phase.
Genelife Clinical Research offers a full range of services for Phase
I-II clinical trials including study design, protocol development,
medical oversight from practicing physicians, site monitoring,
regulatory affairs, database development, biostatistics and data
management.

6. We have developed early phase units within hospitals in India,
Singapore, and Central and East Europe. This provide direct
emergency room access to the subject which is ideal for early
phase study.
Genelife Clinical Research has developed an automated system
for site feasibility and section of early phase clinical trials to select
sites suitable for phase I-II studies.
End Point Studies and Observational Studies
Genelife Clinical Research has extensive experience in Phase III
and Phase IV clinical Trials in different therapeutic areas.
Genelife has conducted/conducting more than 40 global and
domestic clinical trials.

7. Genelife Clinical Research possesses an attitude of difference
with its therapeutic area wise approach for all segments.
We have taken an innovative initiative of developing Theme
Corelab for assisting Clinical Trials with expertise of core-lab in
minimal expenses.
Knowledge Base
Clinical Operations Expertise
Expertise of Investigational tests
Large Data Base of each
Therapeutic area Investigators
Help you determining methodology
for your desired endpoints to
demonstrate safety and performance
, Innovative designs that deliver what
you want Designed customizable
scores and statistical tools
Expertise on Medical out-comes and
their evaluations in reference to the
disease progress and the
investigational product, Inputs in
Designing efficacy and safety trials
Theme core-lab ° is an Expert work
up on theme of a core laboratory for
advanced investigations like
Histopathology, ECG, EEG, Imaging
investigations, mechanical tests
outcomes such as pulmonary function
tests etc. pertaining to respective
therapeutic areas
Disease surveillance reports on
several therapeutic areas Data bases
of many association / societies

8. Project Management is our core competency. We have created an
infrastructure that is based upon some of the most experienced
program and project managers and seasoned investigators who
can smoothly guide any project from the bench to the bedside with
unparalleled speed. Genelife uses Project Managers who have
broad experience in the conduct of complex clinical trials, a key
element to study success. Additionally, we believe, that the Project
Manager’s experience with the therapeutic area being studied is
very important. Our Project Managers are supported by well-
defined, time-tested processes to ensure the completion of study
with limited time and budget.
Project Management
Status, Issues, Results
of process and
project evluations;
measures and analysis
C rr c
e a tio
o e tiv
c
n
What
to monitor
How To Do
How To Do
t
Commitmen s
Project requirements
Technical issues
Completed project components
Acceptance reviews and tests
Plans
Replan
Status, issues
results of
progress and
milestone
review
Corrective
action
SFA -
PP -
PMC -
Site & Study Feasibility Analysis
Project Planning
Project Management And Commissioning
“Effective Project Management is a key element to study success”

9. Genelife has long standing association with few of the esteemed
medical institutes. Genelife has a database of over 900
investigators in all regions of India. These investigators are from
government and private institutions. Considering shrinking
patient population we have identified investigators in tier 2 and 3
cities. Genelife offers unique access and optimal utilization of
opinion leaders, principal investigators, clinics, special subject
populations, regulatory venues, and other trial resources.
Genelife has significant experience in conducting site monitoring.
An onsite monitoring will address regulatory compliance, subject
informed consent, drug accountability, and comparison of
selected CRF data against source documentation.
Clinical Operations

10. Genelife’s Data Management Department dedicates itself to
assuring the integrity of the data generated and its meaningful
interpretation. This is accomplished with rigorous Quality Control.
Genelife follows firm techniques and review procedures to
maintain the integrity of the clinical Trial data. Data management
team speeds the clinical trial process and ensures that data
collection, validation and quality control of data are accurate and
consistent. Our understanding of nCRF and eCRF enables us to
provide the optimum solution for each project. We offer a full range
of EDC services through our own tool using PHP as front end and
MY SQL for database. It is CDISC compliant and can be tailored
to meet all requirements.
Data Management
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CRF and Database designing Reconciliation of external data
Validation & database validation Discrepancy & Query
specifications Management
Programming & maintain Clinical Data Coding
validation checks Data Quality Control
Data Receipt, Logging, and Data Lock & Database Transfer
Tracking Data Management Reporting
Double Data Entry

11. Genelife Clinical Research offer excellence in SAP writing through
final analysis reporting. The Biostatisticians at who have
extensive experience with ICH E9 as well as analysis and
reporting of clinical trial data. We at Genelife develop the
statistical analysis plan (SAP), design all required tables, listings,
and graphs, and provide final output of all clinical trial data and
final analyses. Our experienced statisticians also provide insight
into the need for expanded analyses in order to clarify a trial’s
outcome with respect to all endpoints evaluated.
For randomization we have developed a computerized central
randomization system that fully validated and 21 CFR, Part 11
compliant. This central Randomization system provide rapid, and
secure access to randomization. This is 24 hour online facility
through which investigators can generate randomization code.
Random
Study Population
Treatment
Control

12. Medical Writing
Genelife Clinical Research provides qualitative medical writing
service for Clinical Trials. Our medical writing team has wide
experience in writing Protocol writing and Clinical study report of
complex drugs. Our reports and Protocols have been excepted by
all regulatory bodies.
With extensive experience, we provide medical writing services as
a whole or at any stage of medical writing.
We have also hired services of some global consultant of study
designing.
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Manuscripts Protocol, Investigator
Slide Kits Brochure Financial Disclosure
Posters Patient narratives
CTR Summary Abstracts
CSR Informed consents
Annual Safety Reports Risk profile

13. Genelife’s Medical Safety department offers preparation, review,
approval and reporting of all SAEs reported along with tailored
risk-management strategies across all stages of Product
Development consistent with the requirements of applicable
regulatory bodies.
Pharmacovigilance
þAE and SAE logging, tracking, þPeriodic safety updates
coding as per MeDRA/WHOdrug þSafety analysis and benefit-risk
þSafety/Medical monitoring evaluation
þMedical review of data listings þClinical safety reports
þReview of medical coding data
þPreparation of CTD Module II
þIndividual case safety reports
þExpedited reporting of SAEs
Our Regulatory Department deals with Regulatory Submissions
in and outside India to get necessary clearance from regulatory
bodies for the Study. We have collaborators and consultants who
are able to get faster clearance from any regulatory body.
Regulatory Affairs

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Technologically advanced CRO
Time bound completion of Project
Fast recruitment
Large investigator pool
Allows sponsor to view real-time project development
Global Operations
USPs
èTransparent and technologically advanced Service
# EDC
# eDocumentation Control System
# Project Management Software
# Central Randomization Software
èBetter Risk Assessment & Management Skill
èSource Data Verification 100%
èExtensive experience working alongside other CROs and understand the
challenges that sometimes arise with multi-CRO integration.
èGlobal Presence
Salient features

15. Genelife Clinical Research Pvt. Ltd.
Your Trustworthy partner in Product Development

16. Asia
12, Ground Floor, Evershine Mall, Chincholi Bunder,
Malad(W), Mumbai-400064, Maharashtra. India
Telephone:+91-22-65242555/67083284
USA
4010 Moorpark Avenue,
Suite 226, San Jose, CA 95117
Telephone: +1-866-994-3121
UK
12, Enterprise Place, 175,
Church Street East, Working, Surrey,
UK GU216AD | Telephone: +44-7424335288
Europe
Dr. Amal k. Mukhopadhyay, Elbgaustrasse 71,
22523 Hamburg Germany
Telephone: +49-163-3243522
www.genelifecr.com