1. Quartesian Capabilities
The material contained in this presentation is proprietary and confidential to Quartesian. Quartesian provides it to its clients for its sole use.
Access to this presentation should be restricted to authorized individuals. All documents are the property of Quartesian.

2. Infrastructure
• Headquarters
– Princeton, NJ
• Business Development
– San Diego, CA
• Kharkov, Ukraine
• Bangalore, India
• Global IT Infrastructure
– US-Based IT Hub;
Global Secure Network
Quartesian: At a Glance
A Brief Background
• Founded in January 2003
• Began as a Statistics and
Programming Consultancy
• Added CDISC, eDC,
Clinical Data Management
and Medical Writing
and Communications
• Data Management Process for
Risk Based Monitoring
• Embracing Disruptive
Technologies in Clinical Research
- Cloud Computing and Mobile
Platforms
- Analytics in the Life Science
Space
Bandwidth
• 110+ People Corporate Wide
Serving a Global Client Base
• 80+ Clients Served Over
• 280+ Clinical Studies

3. Quartesian: Follow the Sun
Bangalore, India
Kharkov, Ukraine
Princeton, NJ
San Diego, CA

4. Quartesian: Services and Models
Services Phase I-IV
Clinical Trials
• Data Management and EDC
• Statistics and Programming –
Statistical and PK Analysis, CDISC
• Medical Writing –
Protocols, IBs, CSRs,
Medical Communications
Delivery Models
• In-Sourcing – Onsite, Offsite,
Blended Onsite/Offsite
• Functional Outsourcing
• Traditional CRO Model –
Various Scope of Services

5. Quartesian: Services and Models
Insourcing and Functional Outsourcing
• Two top 10 CROs
- Tables, Listings and Figures
- Novel Methodologies
- CDISC SDTM and ADaM
• Top 10 Pharma Company
- Late Phase Studies - sNDA
- Integrated Summaries of Safety
- CDISC SDTM and ADaM
• Top 10 Biotech Company
- Statistical Analysis Plans
- Tables, Listings and Figures
- Novel Methodologies
- CSR and Medical Communications

6. Quartesian: New Technologies
eDC Technology
• Near Term
- Economic Early Phase
Solution
- ”Express” Version for HV,
BA/BE Studies
• Long Term
- Scalable
- RBM Functionality
- “Add-on” Modules
Analysis and Reporting
g
• Collaborative Open Source Based on R
Language
• Statistical and PK/PD Modules
- Simulations
- Co-primary Endpoints
- Randomizations for different study
designs
- Novel Graphics
• Analytics in the Life Science Space

7. Quartesian: Therapeutic Experience
7

8. Quartesian: Experienced Leadership
Senior Management
• Average 20+ Years in
Clinical Research and Development
– Top Tier and Mid-sized
Pharmaceutical Companies
– Large and Mid-Sized CROs
– Clinical Pharmacology Units
– Academia
– Regulatory Authorities
• Academic Backgrounds
– Clinical Pharmacology
– Statistics
– PK/PD Modeling
– Management Information Systems
– Computer Science
– Engineering

9. Quartesian: Building the Team
Recruitment
• Selective List of Universities; Incubator Programs
• Public Training Modules; Thought Leadership
• Competitor Intelligence in Growing Global Talent Pool
Training
• Premium Talent are Trained in Role-Based Modules
– Statistical Programming
– Data Management
– Medical Writing
• Continued Development in the Clinical Trial Knowledge Base
– Clinical Trial Process
– ICH and 21CFR
– Current Best Practices in Clinical Data Interchange and Standards
Retention
• Competitive Compensation in Local Markets
• Empowerment of Employees
Staff
Development

10. Quartesian: Data Management Process Study Start-Up
• Data Management Plan
• Design and Build Electronic Case Report Form
(eCRF) and Database – CDISC CDASH
• Edit Check Programming
• User Acceptance Test (UAT) of database
(eCRF screens) and Edit Checks
• Database in Production
• Site Assessment and Training
• External Data Interoperability with – CDISC ODM

11. Quartesian: Data Management Process Study Start-Up
Data Management Plan
• Comprehensive Document
• Covers all Aspects of Data Management
– Database Set-Up
– Status Reports
– Quality Control
– Database Transfer and Archive

12. Quartesian: Data Management Process Study Start-Up
Design and Build Electronic Case Report Form (eCRF) and Database
• eCRF Design – Could be CDASH Compliant Mapping Protocol Defined
Assessments to a Data Capture Model
• Assessments within Scheduled Events
• Data Attributes
• Navigation and Functionality
• Field Validations
• Placeholders for ECG Findings
• Clinical Laboratory and Other External Collection Points
• Edit Check Programming
• User Acceptance Test (UAT) of Database (eCRF screens) and Edit Checks
• Database in Production

13. Quartesia n : D a t a M a n a g e m e n t Process Study Start-Up
Final Protocol
and CRF
Database
Design / Build / UAT Process
Database objects are built
in test instance using a CRF
Changes?
Database structure is
exported for review
YES
NO
Circulate Sign-Off Sheet
Enter test data for two patients. Make any necessary changes
Export database to production instance

14. Quartesian: Data Management Process Study Start-Up
Handling Data from
Multiple Sources – CDISC ODM
• eSource
• Cross Database/
File Management Systems
• Preserve Structure
• Preserve Content Meaning
Site Assessment
and Training
• Connectivity and Client Images
• User Roles and Profiles
• System Access and Security

15. Quartesian: Data Management Process Study Conduct
• Data Flow – EDC
• Transfer of Obligations and
Quality Control Points
• Clinical Laboratory and PK Data
Integration
• Data Validation
• Database Soft Lock

16. Legend:
Investigator
Sites/CRA
External Data
Source
Investigator
Sites
Quartesian
Activity
controlled from
Quartesian USA
Quartesian: Data Management Process Study Conduct
Quartesian Data Flow – EDC –Transfer of Obligations and Quality Control Points
Data entered from
client machine at
the investigator site
Data transferred to
back-end database
via SSL
Field level checks
and automatic
queries fired for
data edit checks
Generate Manual
Data Queries
Monitor and Data
Management Data
Review
UPDATE
DATABASE
Monitor and data management
database updates are logged
and reports are reviewed
periodically from the USA
Data transferred from 3rd party
vendors are controlled from the
USA. This includes test transfers,
data specifications and transfer
media
Automated queries are
monitored in the USA
Manual data query replies
are filtered in the USA
before they are passed
back to the data hub in
Bangalore India
Manual data queries are
directed to a central location
in the USA for review and
quality control before they
are sent to the sites/CRAs
Data Query
Replies
External Data

17. Quartesian: Data Management Process Study Close-out
• Draft TLFs for Data Review
• Review Comments on Coding and
TLFs from Sponsor
• Additional Queries Issued Based
on Data Review
• All Queries Resolved
• Database Lock
• Submission-Ready Deliverables

18. Quartesian: Data Management Process Study Close-out
Database Lock
• Medical Coding
• Draft TFL for Data Review
• Review Comments on Coding and TFL from Sponsor
• Additional Queries Issued Based on Data Review
• All Queries Resolved
• DB Hard Lock

19. Quartesian: Analysis and Reporting
Services
• Statistical Methods Consultations
oNovel Methods: Gatekeeping for
Multiplicity Adjustment
oNon-Standard Method
Implementation
oSimulations to Determine and
Compare Performance of Various
Methods
• Sample-Size Calculations
• PK/PD Modeling
• Statistical/CDISC/PK/PD
Programming
Deliverables
• Statistical Sections of Protocols
• Statistical Analysis Plans (SAPs)
• Outputs for CSRs:
– Tables
– Listings
– Figures
• SDTM Datasets, ADaM Datasets,
Other Analysis Datasets

20. Quartesian: Analysis and Reporting
Process and Methods
• Specs Define Dataset Structure
• Annotated Table Shells Define Table Programming
• Independent QC
• Senior Reviews
• Code Reviews
• Centralized Status Tracking
• Adherence to SOPs

21. Quartesian: Analysis and Reporting
Clinical Data Interchange– CDISC
ODM
• Cross Platform
• Cross Database/
File Management Systems
• Preserve Structure
• Preserve Content Meaning
Analysis and Reporting
• CDISC SDTM & Define.xml
• CDISC ADaM & Define.xml

22. Quartesian: Medical Writing
• CTD Components, eCTD Summary & Overview Documents
• Integrated Summaries for CTD Module 5
• 120-day Safety Updates, Responses to FDA Requests
• 510ks, PMAs, 505b2 Submissions
• Preclinical and Clinical Study Reports
• Patient Safety Narratives
• Annual Reports
• IND Development, Paper or eCTD Format
• QA/QC Versus Source Documentation
• Post Approval and Marketing Support, i.e. Posters/Manuscripts,
Sales Training, Etc.

23. Thank You!