Download - Quartesian capabilities-2013
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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!