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Quartesian Capabilities

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

Quartesian: Follow the Sun

Bangalore, India

Kharkov, Ukraine

Princeton, NJ

San Diego, CA

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

Quartesian: Services and Models

Delivery Models

• In-Sourcing – Onsite, Offsite,

Blended Onsite/Offsite

• Functional Outsourcing

• Traditional CRO Model –

Various Scope of Services

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

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 Reportingg

• 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

Quartesian: Therapeutic Experience

7

• 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

Quartesian: Experienced Leadership

Senior Management

• Academic Backgrounds

– Clinical Pharmacology

– Statistics

– PK/PD Modeling

– Management Information Systems

– Computer Science

– Engineering

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

Quartesian: Building the Team

StaffDevelopment

• 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

Quartesian: Data Management Process Study Start-Up

• Comprehensive Document• Covers all Aspects of Data Management

– Database Set-Up

– Status Reports

– Quality Control

– Database Transfer and Archive

Quartesian: Data Management Process Study Start-Up

Data Management Plan

• 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

Quartesian: Data Management Process Study Start-Up

Design and Build Electronic Case Report Form (eCRF) and Database

Quartesian: Data Management Process Study Start-Up

DatabaseDesign / Build / UAT Process

Final Protocol and CRF

Changes?

Database objects are built in test instance using a CRF

Database structure isexported for review

YES

NO

Circulate Sign-Off Sheet

Enter test data for two patients. Make any necessary changes

Export database to production instance

Handling Data from Multiple Sources – CDISC ODM

• eSource

• Cross Database/

File Management Systems

• Preserve Structure

• Preserve Content Meaning

Quartesian: Data Management Process Study Start-Up

Site Assessmentand Training

• Connectivity and Client Images

• User Roles and Profiles

• System Access and Security

• Data Flow – EDC• Transfer of Obligations and

Quality Control Points• Clinical Laboratory and PK Data

Integration• Data Validation • Database Soft Lock

Quartesian: Data Management Process Study Conduct

Investigator Sites/CRA

Legend:

External DataSource

InvestigatorSites

Quartesian

Activity controlled fromQuartesian USA

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 aremonitored in the USA

Manual data query repliesare filtered in the USAbefore 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

Quartesian Data Flow – EDC –Transfer of Obligations and Quality Control Points

Quartesian: Data Management Process Study Conduct

• 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

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

Quartesian: Data Management Process Study Close-out

Services• Statistical Methods ConsultationsoNovel Methods: Gatekeeping for Multiplicity AdjustmentoNon-Standard Method ImplementationoSimulations to Determine and Compare Performance of Various Methods• Sample-Size Calculations• PK/PD Modeling• Statistical/CDISC/PK/PD Programming

Quartesian: Analysis and Reporting

Deliverables• Statistical Sections of Protocols• Statistical Analysis Plans (SAPs)• Outputs for CSRs: – Tables – Listings – Figures• SDTM Datasets, ADaM Datasets, Other Analysis Datasets

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

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

Quartesian: Analysis and Reporting

• 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.

Quartesian: Medical Writing

Thank You!