Quartesian capabilities-2013
 

Quartesian capabilities-2013

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Basic Capabilities

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    Quartesian capabilities-2013 Quartesian capabilities-2013 Presentation Transcript

    • 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.
    • Quartesian: At a Glance A Brief History Bandwidth Infrastructure • Founded in January 2003 • Began as a Statistics and Programming Consultancy • Added CDISC, EDC, Clinical Data Management and Medical Writing and Communications • Continued Expansion into a Larger Clinical Trial Space • 100+ People Corporate Wide Serving a Global Client Base • 70+ Clients Served Over 10 Years • About 300 Clinical Studies in the Past 10 Years • Headquarters – Princeton, NJ • Business Development – San Diego, CA • Kharkov, Ukraine • Bangalore, India • Global IT Infrastructure – US-Based IT Hub; Global Secure Network
    • Quartesian: Follow the Sun Kharkov, Ukraine Princeton, NJ San Diego, CA Bangalore, India
    • Quartesian: Areas of Excellence Services Phase I-IV Clinical Trials Delivery Models • Data Management and EDC • In-Sourcing – Onsite, Offsite, • Statistics and Programming – Statistical and PK Analysis, CDISC • Medical Writing – Protocols, IBs, CSRs, Medical Communications Blended Onsite/Offsite • Functional Outsourcing • Traditional CRO Model – Various Scope of Services
    • Quartesian: Therapeutic Experience CNS (12%) 3% 3% 3% Cardiovascular (9%) 12% Dermatology (2%) 15% Gastro-Intestinal (16%) 9% 2% Men's Health (3%) 3% 16% 3% Anti-Infective (5%) Musculoskeletal (6%) Oncology (17%) Ophthalmology (3%) 17% 6% 3% 5% Renal (3%) Respiratory (15%) Rheumatoid Arthritis (3%) Metabolism (3%) Vaccine (3%)
    • Quartesian: A Team of Experienced People Senior Management • Average 20+ Years in Clinical Research and Development – Top Tier and Mid-sized Pharmaceutical Companies • Academic Backgrounds – Clinical Pharmacology – Statistics – PK/PD Modeling – Large and Mid-Sized CROs – Management Information Systems – Clinical Pharmacology Units – Computer Science – Academia – Engineering – Regulatory Authorities
    • Quartesian: Building the Team Recruitment • Selective List of Universities; Incubator Programs • Public Training Modules; Thought Leadership • Competitor Intelligence in Growing Global Talent Pool Training Staff Development • 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: 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
    • 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
    • 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
    • Quartesian: Data Management Process Study Start-Up Final Protocol and CRF Database objects are built in test instance using a CRF Database structure is exported for review YES Database Design / Build / UAT Process Changes? NO Circulate Sign-Off Sheet Enter test data for two patients. Make any necessary changes Export database to production instance
    • Quartesian: Data Management Process Study Start-Up Site Assessment and Training Handling Data from Multiple Sources – CDISC ODM • Connectivity and Client Images • eSource • User Roles and Profiles • Cross Database/ • System Access and Security File Management Systems • Preserve Structure • Preserve Content Meaning
    • 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
    • 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 Automated queries are monitored in the USA Monitor and Data Management Data Review Field level checks and automatic queries fired for data edit checks Generate Manual Data Queries Manual data query replies are filtered in the USA before they are passed back to the data hub in Bangalore India UPDATE DATABASE Data Query Replies 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 Legend: Investigator Sites/CRA External Data Source Monitor and data management database updates are logged and reports are reviewed periodically from the USA External Data Data transferred from 3rd party vendors are controlled from the USA. This includes test transfers, data specifications and transfer media Investigator Sites Quartesian Activity controlled from Quartesian USA
    • 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 • DB Hard Lock • Submission-Ready Deliverables – CDISC SDTM, ADaM – CDISC ODM
    • 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 Analysis and Reporting Clinical Data Interchange – CDISC ODM • CDISC SDTM & Define.xml • CDISC ADaM & Define.xml • Cross Platform • Transfer, Archive, • Cross Database/ Data Interchange File Management Systems • Preserve Structure • Preserve Content Meaning
    • Quartesian: Statistics and Programming Capabilities • • • • • • • • • • • • SAP Writing Statistical Sections of Protocols Statistical Methods Consultations Novel Methods: Gatekeeping for Multiplicity Adjustment Non-Standard Method Implementation Simulations to Determine and Compare Performance of Various Methods Sample-Size Calculations Outputs for CSRs: – Tables – Listings – Figures SDTM Datasets, ADaM Datasets, Other Analysis Datasets Exploratory and Ad-Hoc Analyses Validation of Existing Outputs, Post-text and In-Text Tables PK Analysis
    • Quartesian: Statistics and Programming Quality Process • Specs Define Dataset Structure • Annotated Table Shells Define Table Programming • Independent QC • Senior Reviews • Code Reviews • Centralized Status Tracking • Adherence to SOPs
    • 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.
    • Thank You!