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  • 1. CONFIDENTIAL 09/29/11 Clinical Trial Management & Clinical Data Management Systems Technical/Strategic Part - 1
  • 2. CONFIDENTIAL 09/29/11 CLINICAL DATA MANAGEMENT - INTEGRATION LOCAL LAB/S DATA SAS Drug Discovery (Operational Clinical Database & Repository) SAS Analytics (Tables, Listings & Study Reports) Medical Coding (MedDRA &WHODD) Electronic transfer of Lab, ECG & Imaging data per CDISC module Electronic Data Capture (EDC application) TRIAL DATA Web Access Online real time access through J-review CDMS Submission by CDISC ADAM Submission by CDISC SDTM CTMS (Planning, Recruitment, Budgeting & Tracking) PROJECT MANAGEMENT Aris/Argus Global (Pharmacovigilance) DRUG SAFETY IVRS SAS Connect Crystal Reports/ COGNOS/ INFORMATCA (Business Intelligence –Reporting) Patient Diary Paper/ Electronic/ IVR DATA DSMB Reports SMB Reports CSMB Reports
  • 3. CONFIDENTIAL 09/29/11 Clinical Data Management – Resources Required In-house - CDM Datacenter Hw + Sw Sponsor EDC+SAS+Medra +WHO+MeDra+Costat Staff Pharmaco. Sw/Tools Regulatory Sw/Tools Pr.Mgt.
    • In-house – CDM Staffing
    • Program Manager
    • Study Data Manager
    • Content Writer
    • CRF Builder
    • CRF designer
    • Database Programmer
    • Data Validation Associates
    • Statistical Analyst/Programmer
    • Clinical Data Analyst
    • Medical Coder
    • AE Reporting Specialist
    • Quality Assurance
  • 4. CONFIDENTIAL 09/29/11 Clinical Data Management – Resources Required Technology-Business Integration of CDM DM SYSTEM Sponsor EDC Statistics Pharmaco Lab & External Pr.Mgt.
  • 5. INTEGRATED DATA MANAGEMENT SYSTEM Lab Data Data Import to CDM Repository (Directory Structure) SaS & SaS Tools Imaging Data Medical Coding Data Import to SaS Data Export from SaS Datacenter Biomarkers & Others Genetic Data EDC SYSTEM
  • 6. Clinical Data Management System/Process CONFIDENTIAL 09/29/11 CTMS CDMS Spectrum CDMS standards CRF dev. & Approval DM Plan & Approval EDC Application dev. & Appr. Study db struct. dev. & approval Validation Verification of CRFs & D.Entry Discrepancy resolution & management Electronic File Transmission & Management Medical Coding & Approval Reconciliation of AE’s & SAE’s Quality Evaluation of Study database Study Db Lock  Statistical Analysis & Reporting 1 2 3 4 5 6 7 8 9 10 11 12
  • 7. CONFIDENTIAL 09/29/11 Clinical Trial Management System
    • Other Services
    • Clinical trial strategy and design development.
    • 2. Investigational plan creation.
    • 3. Analysis plan development.
    • 4. Investigator and site identification, recruitment, and qualification.
    • 5. Study document development.
    • 6. Site initiation and training.
    • 7. Database development, including EDC options.
    • 8. Data and query management.
    • 9. CEC/DSMB management.
    • 10. Study monitoring.
    • 11. Site and sponsor auditing.
    • 13. Clinical report generation.
    • 14. Presentation and journal article preparation.
    • 15. SOP development.
    • 16. Comprehensive staff training .
  • 8. CONFIDENTIAL 09/29/11 Technical overview of a Clinical Trial Management System Application Back-end Database Datamart, Datawarehouse Digital Dashboard for Trial Managers Business Intelligence Interface Data
  • 9. CONFIDENTIAL 09/29/11 Clinical Trial Management System/Software Integration with CDMS
    • CTMS Modules
    • Project Mgmt.
    • Budgeting & Finance
    • Patient Management
    • Investigator Mgmt.
    • EC/IRB Approvals
    • Compliance with FDA
    • AE Reporting System
    • eCTD ( electronic Common Technical Document ) an interface for the pharmaceutical industry to agency transfer of regulatory information
    • CDM Modules
    • Project Mgmt.
    • EDC
    • Pharmaco
    • SAS
    • Data Analytics
    What is needed? A: Data integration with central lab, electronic patient diaries(ePro, IVRS, ECG and other third party applications and databases (including CDMS and CTMS) into one comprehensive software application
  • 10. CONFIDENTIAL 09/29/11 CTMS + CDMS + Pharmaco + Regulatory CDM + Pharmaco + Regulatory CTMS + Pharmaco + Regulatory Spectrum Pr.Mgt. CTMS Staff Datacenter Hw + Sw Sponsor EDC+SAS+Medra +WHO+MeDra+Costat Staff Pharmaco. Sw/Tools Regulatory Sw/Tools Pr.Mgt.
    • Medical Monitor
    • Project manager
    • Chief Investigator
    • Principal Investigator
    • Clinical Research Coordinator
    • Clinical Research Associates
    • Associate Staff
  • 11. DATA MANAGEMENT SERVICES Functional CONFIDENTIAL 09/29/11
    • 1.1 CRF Design Specifications
    • 1.2 CRF Annotation Build
    • 1.3 CRF Database design build
    • 1.4 CRF Physical Screen Design
    • 1.5 CRF UAT Testing
    • 2.1 Edit Checks Specification
    • 2.2 Edit checks Specification
    • programming
    • 2.3 Edit Checks UAT Testing
    • 2.4 Medical Coding Setup
    1.1 Lab Specifications 1.2 Lab Specifications reconciliation checks 1.3 Lab Reconciliations Checks programming 1.4 Lab Reconciliations Checks programming UAT 2.1 ECG Specifications 2.2 ECG Specifications reconciliation checks 2.3 ECG Checks Specification reconciliations checks programming 2.4 ECG Checks Specification reconciliations checks programming UAT 3.1 Diary Specifications 3.2 Diary Specifications reconciliation checks 3.3 Diary Specifications reconciliation checks programming. 3.4 Diary Specifications reconciliation checks programming UAT 4.1 PK Specifications 4.2 PK Specifications reconciliation checks 4.3 PK Specifications reconciliation checks programming 4.4 PK Specifications reconciliation checks programming UAT CRF External SET-UP ACTIVITIES
  • 12. DATA MANAGEMENT SERVICES CONFIDENTIAL 09/29/11 1.1 Double Data Entry(Paper Only) 1.2 External Data Vendor management 1.3 Data Management Discrepancy Management 1.4 SAE Reconciliation with Drug Safety / Pharmocovigilance 1.5 Medical Coding [AE, Cocomitant Medication, Medical history] 1.6 Investigator Discrepancy Data Management 1.7 Monitors Discrepancy Data Management 1.8 Clinical Review Discrepancy Management 1.9 External Data Discrepany Management 1.10 Clinical Review Report Management 1.11 Data Mgmt. report Management 1.12 Clinical/Data Mgmt. Metrics Report Management 1.13 Statistical review Management DISCREPANCY MANAGEMENT ( data entry/tracking, data cleaning, query resolution, reconciliations, reviews etc.) CONDUCT ACTIVITIES
  • 13. DATA MANAGEMENT SERVICES CONFIDENTIAL 09/29/11 1.1 Quality Assurance of Data [Error Rate] 1.2 Patients Listings reconciliation including visits 1.3 SAE Reconciliation 1.4 Medical Coding 1.5 All queries resolved 1.6 All Data Discrepancies resolved 1.7 Lab Data Reconciled 1.8 ECG Data Reconciled 1.9 Diary data reconciled 1.10 PK Data Reconciled Data handling, reviews and QA, QC CLOSEOUT ACTIVITIES
  • 14. DATA MANAGEMENT SERVICES CONFIDENTIAL 09/29/11 1.1 SAS dataset package/eCTD 1.2 CRF data package/eCTD 1.3 DM Document package/eCTD :  Data Management Plan  Data Validation Plan  CRF Completion guidelines  CRF database annotations  CRF Evident Corrections  Self Checks Specification (CRF)  Edit Checks Specifications (Lab, ECG, Diary, PK) eCTD Management POST_LOCK ACTIVITIES
  • 15. THANK YOU Satender Sajwan Global Clinical Data Management / Integration Expert (Business) Mobile: 732-910-9056