Corporate Presentation

Genelife Clinical Research

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.

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.

Clinical Services

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

Study Lifecycle at Genelife

Operational Plan

INVESTIGATOR SELECTIONPLANNING REGULATORY STATISTICAL INPUT

MEDICAL COMMUNITY MEDICAL 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

Project Approach

SFA- Site & Study

feasibility

Analysis

PP- Project Planning

PMC- Project

Management

and Commissioning

E-Documentation System

Data ManagementSe

t Up • 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

Proc

essi

ng • Double Data entry & verification

• Query Management• Clinical data Coding• Data Import/Export• Audit trails and access

log maintenance• Project specific

Document Management• SAE** Reconciliation

Revi

ew

• 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

Data ManagementCl

ose-

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-EXCESSEDC Studies-Oracle RDC, Medidata RAVE, INFORM

Statistical Analysis and ProgramingSA

P cr

eatio

n &

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

Stati

stica

l Ana

lysi

s • 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/

Val

idati

on

• Programming and quality review based on written specifications

• Independent validation of all project-specific programming

• Quality review of all outputs

• Senior review

Statistical Analysis and Programing

Repo

rt G

ener

ation

• Prepare integrated clinical/statistical Reports

• Programming

• Report generation

Statistical Tool-SAS-9.2

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

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

Industry Challenges

Regulatory Approvals Reluctant InvestigatorSites SelectionPatient Recruitment

Transforming Customer Expectation

Hassel free regulatory approvalTime bound completion of ProjectFast Requirement Large investigator poolAllows sponsor to view real-time project development

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

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

Tools

The tools used at Genelife Clinical Research are: Project Management SoftwareClinical Data Management SoftwareDocumentation Control SystemCentral Randomization Software Temperature Control System for IP

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

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

Thank You

www.genelifecr.com