Brief introduction of Panther CTMP platform from Edetek. http://www.edetek.com

1. EDETEK Introduction

2. AGENDA
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Introductions
EDETEK Overview
CDISC Compliance
Panther CTMP™
Quality Control
CDISC Data Analytics and Submission Services
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3. INTRODUCTION TO EDETEK
Company
CDISC Commitment
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 CDISC “Gold Member”
 Member of 6 CDISC Working Groups:
SDS, ADaM, CDASH, ODM, CT, Share
 Participated in CDISC Pilot
 CDISC Registered Solution Provider (RSP)
for SDTM, ADaM, & Define.xml
Services
Quality Work
Full-service CRO established in 2009
Headquarter in Princeton, NJ
Branch office in Beijing
ISO 9001-2008 Certified
Over 50 member team with more than 30
dedicated to CDISC Services
 Partner with multiple clinics in US and 600+
sites in China
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 Full data management services to 20
pharmaceutical companies
 Prepared hundreds of study packages
 Completed 4 NDA submission
(including ISS/ISE packages) in 2013
 Customers including largest
pharmaceutical companies
 World-wide data standardization
partner of HCL
Study Design – Protocol Development
Monitoring
Clinical Data/Study Management
Stats and Programming
CDISC Conversion/e-Submission
Medical Writing
Technology & Platform Provider
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4. THERAPEUTIC AREA EXPERIENCE
CDISC Involvement
 Oncology
As an example
 Other therapeutic areas
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Anti-inflammatory/Pain
Anti-infective
Neurology/CNS
Cardiovascular
Gastroenterology
Ophthalmology
Allergy
Vaccine
PK/PD
Diabetes and metabolic
disease
 Dermatology
 CDISC SDS Oncology SubTeam Member
 CDISC Oncology Terminology
Sub-tem Member
Oncology Library
 Standard Libraries for Solid
and Liquid Tumor
 Endpoints: OS, PFS, ORR, DFS,
TTF, TTP, PRO, QOL
 CTC AE Library
Oncology Module
 Dedicated Oncology Mapping
Module
Submission Experience
 Prepared multiple NDA
Submission Packages
 SDTM, ADaM, TLF, CSR
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5. PANTHER CTMP™ – COMPLETE PLATFORM
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6. PANTHER CTMPTM GOALS
Standardized & streamlined process
Automated programming
Elimination of redundancy
Performance
Reduced error
Reduced manual efforts
Reduced time /
resource requirements
Cost
Quality
Control
Standard and Metadata driven
Open architecture for integration and access
Elimination of black boxes and bottle necks
Make No Compromise!
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Built-in QC/QA framework
Single version of truth
Reduction of human errors
Enhanced communication

7. PANTHER CDMSTM
External System
Unified Access Portal
Web Services
CRF Design
Study Administration
Data Repository
Forms & Items
Study
Management
Data Capture
Presentation
Layout
Site
Management
External Data
Integration
Standardization
(SDTM)
Edit Checks
Investigator
Management
Query
Management
Coding
Standardization
Rules
Patient
Management
Document
Management
Panther CDMSTM
Study Protocol
CDASH
Sponsor
Standards
Edit Check
Library
Data Standardization
Reporting
Monitoring
Administration
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Coding

8. COMPREHENSIVE QUALITY CONTROL FRAMEWORK
CRF
Design
Study
Raw Data
SDTM
Data
ADaM &
Results
eCTD
CRF Design
Validation
Study Raw
Data Validation
SDTM Data
Validation
Analysis Data &
Results
Validation
Submission
Package
Validation
Quality Control
Framework
• Quality Check
• Quality Assurance
• Monitoring &
Tracking
• Exception
Resolution
• Reporting
Quality Control
Framework
Repository
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Web Portal

9. PANTHER CLINICAL DATA WAREHOUSE
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Explore changes in treatment effect over time
Integrate Summaries of Safety and Efficacy
Integrate existing information
Provide data for rational decision making
Prospective planning in drug development
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10. CONTACT INFORMATION
Primary Contact:
President: Jian Chen (jian.chen@edetek.com)
EDETEK, Inc.
1 Independence Way, Suite 405
Princeton, NJ 08540
Phone: 609-720-0888/9
Fax:
609-720-0880
E-mail: info@edetek.com
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