Genelife Clinical Research is a clinical research organization established in 2010 in Mumbai, India. Their mission is to be the preferred partner for clinical trial sponsors by providing high quality and innovative product development solutions. They offer a full range of clinical research services including operations, data management, statistics, quality assurance, and regulatory affairs. Genelife takes a systematic approach to clinical trials utilizing tools like project management software, EDC systems, and randomization software. They have experience conducting trials across many therapeutic areas for regulators like DCGI, FDA, and TGA. Their differentiating factors include transparent services, advanced techniques, strong regulatory expertise, and a presence in multiple countries.

1. Corporate
Presentation
Genelife Clinical Research

2. Genelife Background
The company was established with an initiative to provide clinical research services
with assured high recruitment rate and quality data.
The company was founded at Mumbai in February 2010.

3. Mission and Vision
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 needs.

4. Clinical Services
• Clinical Operations
• Data Management
• Statistical Analysis
• Quality Assurance
• Regulatory Affairs
• Medical Writing
• Pharmacovigilance

5. Study Lifecycle at Genelife

6. Operational Plan
INVESTIGATOR SELECTIONPLANNING REGULATORY STATISTICAL INPUT
MEDICAL COMMUNITYMEDICAL WRITING
IN PUT
OPERATION CONTROL REPORTINGPROJECT EXECUTIONASSESSMENT
PROCESS
COST EFFECTIVE
LOW RISK
QUALITY DATA FAST RECRUITMENT BIGGER MARKET
OUT PUT
S
Y
S
T
E
M

7. Project Approach
SFA- Site & Study
feasibility
Analysis
PP- Project Planning
PMC- Project
Management
and Commissioning

8. E-Documentation System

9. Data ManagementSetUp
• CRF Design
• Creation of Project
specific Guidelines
• Database Set-up
• Annotation
• Design
• Query
• Programming
• Validation etc.
• Import/Export Set-up
• Dictionary set-up(e.g.
MedDRA)
• CRF Tracking Set-up
• Protocol Inputs
Processing
• Double Data entry &
verification
• Query Management
• Clinical data Coding
• Data Import/Export
• Audit trails and access log
maintenance
• Project specific
Document Management
• SAE** Reconciliation
Review
• Adverse events
• Margin notes and data
alerts
• Evaluation of medical and
scientific consistency of
data
• Trend Analysis
• Periodic review for
protocol adherence, data
recorded and regulatory
file maintenance
• Data Quality Control

10. Data Management
Close-Out
• 100% Quality Control of
selected patients (i.e. selected
randomly)
• Soft/Hard Locking of
database
• Relevant project closure
documentation (Data
Handling Report)
Paper Based Studies- Open Clinica, Oracle Clinical 4.6, MS-EXCESS
EDC Studies-Oracle RDC, Medidata RAVE, INFORM

11. Statistical Analysis and ProgramingSAPcreation&set-up
• Study objectives are
summarized
• Study population finalized
• Sample size rationale and
statistical power
determination
• Description of statistical
methodology
• Create and finalize
• Programming processes
and directory structures
• Shells of all planned
tables, listings and graphs
StatisticalAnalysis
• Creation and validation of
analysis datasets using
CDISC* standards
• Creation of integrated
databases
• Creation of tables, listings
and graphs
• Exploratory
analysisSummary of
methodologies and results
• ISS & ISE
QC/Validation
• Programming and quality
review based on written
specifications
• Independent validation of
all project-specific
programming
• Quality review of all
outputs
• Senior review

12. Statistical Analysis and Programing
ReportGeneration
• Prepare
integrated
clinical/statistic
al Reports
• Programming
• Report
generation
Statistical Tool-SAS-9.2

13. Contd.
E-Submission
• Creation of e-submission
deliverables
• CRF Annotation
• SAS Transport Files
• Define. PDF/ Define.xml
• eCTD Guidelines
• QA of deliverables
• Hyper linking
• ISI Toolbox, Ultralink
Pharmacovigilance
• Adverse Event Planning
• SAE Reconciliation
• Signal Detection
• Medical Evaluation
• Safety Reports
• Literature Search
• P2 Table

14. Medical Writing
• Manuscripts
• Slide Kits
• PostersCTR* Summary
• CSR
• Annual Safety Reports
• Protocol
• Investigator Brochure Financial Disclosure
• Patient narratives
• Abstracts
• Informed consents
• Risk profile
Medical
Writing

15. Industry Challenges
Regulatory Approvals
Reluctant Investigator
Sites Selection
Patient Recruitment

16. Transforming Customer Expectation
Hassel free regulatory approval
Time bound completion of Project
Fast Requirement
Large investigator pool
Allows sponsor to view real-time project development

17. Innovative Approach
 We have conducted a Disease surveillance report (DSR) in all regions of India to
ensure:
* Fast feasibility and Documentation
* Investigator/Patient Database
* Fast Recruitment rate
* Excess of Patient Data in small cities
* Physician Database
 Study Design
* We have high success rate in NDAC
* We are having maximum Study approvals in India
* Patient and Recruitment friendly study design
 Patient Recruitment
* Audio Visual consenting
* External OPD
* Physician Referral

18. Differentiating Factor
 Transparent Service through:
* EDC
* Documentation Control System
 Advanced Technique:
* Project Management Software
* Randomization
 Better Risk Assessment & Management Skill
 Strong Regulatory Background
 Source Data Verification 100%
 Globally acceptable SOPs
 Policy Enforcement
 Presence in Germany, Denmark, Australia and South Africa

19. Tools
The tools used at Genelife Clinical Research are:
Project Management Software
Clinical Data Management Software
Documentation Control System
Central Randomization Software
Temperature Control System for IP

20. Expertise
S. No. Indication Status Regulatory Body Number of Project
1 Cancer 1Completed/ 1On going 1 AYUSH, GmbH 2
2 Gynecology 1Completed/ 1On going DCGI 2
3 Gastroenterology Completed FDA 1
4 Dermatology Completed 1 FDA, 1TGA 2
5 Male Health Completed AYUSH 2
6 Female health Completed Non-Regulated 1
7 Respiratory 1Completed/ 1On going DCGI 2
8 Liver Dysfunction Completed Non-Regulated 1
9 Ophthalmology On going DCGI 16
10 Hypertension On going DCGI 5
11 ENT On going FDA 4
12 Diabetes On Going DCGI 2
13 Orthopedics On Going DCGI 4
14 Infection On going DCGI 1

21. Expertise
S. No. Indication Status Regulatory Body Number of Project
1 Hemostat On going DCGI 1
2 Stent Completed TGA 1
3 Asthma On going DCGI 1
3 Diagnostics Completed Non-Regulated 1

22. Thank You
www.genelifecr.com