Kreara - Clinical Data management and Biomterics


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Kreara - Clinical Data management and Biomterics

  1. 1. Clinical Data Management and Biometric Services
  2. 2. In a snapshot Project Management Statistical Services Clinical Data Management Medical Writing Medical Coding Training
  3. 3. Project Initiation
  4. 4. Project Plan Director negotiates the contract Project Manager appointed Assigns System Admin and QA for the project Delivery of various initiation documents Project Kick off meeting Work Breakdown Structure Active directories and Change Control Project Initiation Workflow Initiate the project Statement of Requirements Project Initiation Document Master List of Deliverables Work Breakdown Structure Project Schedule Project Plan Quality Plan
  5. 5. Periodic Review and Status Reporting Review outstanding issues on the issue tracker Review QA non conformances Review and document show stoppers Identify potential issues and roadblocks Plan the work breakdown for the next session Setup of Status reports
  6. 6. Security
  7. 7. Security Levels ORGANIZATION PROJECT Access to CVS Access to Project related directory Cabinet file security Remote site security Server security System security Various levels of personal security Access to CVS Access to Project related directory Access to CVS Access to Project related directory Access to CVS Access to Project related directory FTP, Email, VPN security Database security Document filing in the cabinet Access to CVS Access to Project related directory
  8. 8. Disaster Management and Recovery
  9. 9. Disaster Management SAS Programs Documents Versions Data Entry application code Scanned CRFS All Data management documents CVS Repository DATA Database Daily back ups of CVS and database to a back up server Daily back ups of CVS and database to a Remote back up server Weekly media backup on a DVD which will be transferred to a bank locker Automated Automated Manual
  10. 10. Clinical Data Management
  11. 11. Data Management Workflow Data Management Plan CRF Design CRF Manual Data Definition Table Data Validation Document Annotated CRF Database Design EZCRF modification PART 11 Compliance Document Data Entry - Primary Data Entry - Secondary Query, DCF and Resolution Compare Primary and Secondary Database Resolve Conflicts and Queries Critical Values Manual Check
  12. 12. Strategy for CDISC migration Legacy Documents Received Decision regarding data analysis Map blank CRF to SDTM Create SDTM data metadata Create zero observation SDTM datasets Statistical Analysis Plan Create Analysis data metadata Create zero observation Analysis datasets Receive Legacy Data Create SDTM datasets Create Analysis datasets Derived data to SDTM Finalize SDTM datasets Adverse Event and Concomitant medication coding Generate analyses Write Study Report Create Analysis resulkts metadata Reviewers guide Covering Letter Create Define Create XPT
  13. 13. Biostatistical Services
  14. 14. Statistical Analysis workflow Sample Size Justification List of Tables, Listings and Graphs Tables/Listing Templates Program Tables & Listings SAS Code validation and comments Populate Tables and Listings Review Output Revise Code as per the review comments Repeat with more data Statistical Analysis Plan Code Validation and revision
  15. 15. Medical Writing
  16. 16. Medical writing workflow ICH E3 Template Final version of the study protocol Preliminary draft Created Draft Review and Approval Data from Tables and Listing Statistical Report Full CSR Draft Load Locked Data from Tables and Listings FINAL DRAFT CLINICAL STUDY REPORT
  17. 17. Location
  18. 18. Kerala <ul><li>Lower Salaries </li></ul><ul><li>Great Talent Pool – You will find massive numbers of state graduates in any of the major consulting organizations in India </li></ul><ul><li>Lower attrition rate </li></ul><ul><li>Woman empowered state </li></ul><ul><li>Industry friendly government </li></ul><ul><li>Pollution free and Green state </li></ul><ul><li>Less traffic compared to many metros </li></ul><ul><li>Low infrastructure cost </li></ul><ul><li>3 International airports </li></ul>
  19. 19. We have worked with