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Presentation - Phase 1 & BA/BE Process Flow

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Timelines, Regulatory Process

Timelines, Regulatory Process


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  • 1. Info Kinetics Sdn Bhd /Clinical Research Centre
    Connecting Research & People
    Phase 1 Study
    BA/BE Study
    May 2010
    These materials are CONFIDENTIAL and PROPRIETARY and for your review only.  This presentation is subject to revision as required as new information is obtained. Please respect the sensitive nature of this document by limiting its distribution, protecting the contents and refraining from making additional copies.
  • 2. Full Services Under One Roof
    Pantai Hospital Penang
    Data Management
    & Reporting
    Protocol Development
    BE Study
    Phase 1 Study
    IRB / IEC
    Applications
    Bioanalytical
    Regulatory
    Applications
    Subject/Patient
  • 3. Request for Information (RFI)
  • 4. Quality Milestones
    Info Kinetics is the first CRO is Pan-Asia to achieve ISO9001:2000 and OECD GLP accreditation
    2003-2004
    2005-2006
    2007-2008
    2009-2010
    2001-2002
    • First Asian CRO to obtain OECD GLP accreditation
    • 5. Inspected by German Federal Bureau
    • 6. GCP Inspection by French regulatory authorities (Afssaps)
    • 7. GCP Inspection from NPCB (renewal)
    • 8. Migration to ISO9001:2008
    • 9. Company Established
    • 10. First BE Study performed.
    • 11. Complied with ICH-GCP
    • 12. First CRO to obtain ISO 9001:2000
    • 13. Inspections from NPCB and HSA
    • 14. Achieved ISO/IEC 17025 accreditation.
    • 15. Quality manual aligned with ASCLD
  • Clinical Pharmacology Unit
    Full safety support
    ICU & 24-hr emergency
    RFID Subject
    Tracking System
    36-bedded facility
    Pantai Hospital Penang
    Limited Access
    Drug Storage area
    Large Database of
    subjects
    Phlebotomy Stations
    Freezers
    Refrigerated Centrifuge
  • 16. Bioanalytical Laboratory
    Over 70 validated methods (plasma)
    Over 40 validated methods (pharmaceutical)
    LCMS/MS (2)
    GCMS (2)
    RRLC / UPLC (6)
    Agilent OpenLab® Platform
  • 17. Pre-Study Timelines
    Timelines
    Financial & Legal
    Operations
    Sponsor
    Request for Information (RFI)
    2 d
    CDA
    Feasibility Studies
    (Facility Audit)
    TCE
    1 - 2 wks
    Accepts Proposal
    Study Agreement
    Indemnity
    1 - 2 wks
    Protocol Writing
    Inform Consent Forms
    Case Report Forms
    Provide Working Stds
    Method Development & Validation
    (if not validated)
    [4-6 weeks]
    Provide Technical Dossier
    4 - 6 wks
    Regulatory Application
    (CTIL) / (NMRR)
    IEC Application
    (Approval)
  • 18. Study Timelines
    Timelines
    Financial
    Operations
    Sponsor
    Ship IMP to Site
    Subject Screening & Recruitment
    2 wks
    Study Period 1
    (washout period)
    Study Period 2
    Safety Follow-up
    Monitoring Visits
    2 - 4 wks
    Bioanalysis
    4 - 6 wks
    Data Management &
    Statistical Analysis
    2 - 3 wks
    Report Writing &
    Study Closure
    2 - 3 wks
    12-16 wks
  • 19. Regulatory Applications
    The Malaysian Govt. is very supportive of Translational Research.
    Day -21
    Day 7
    Day 1
  • 20. IRB / IEC Applications
    Independent Ethics Committee (JPEC) – ICH GCP standards
    Day -21
    Day 7
    Day 1
  • 21. Request for Information (RFI)
  • 22. Request for Information (RFI)