Presentation - Phase 1 & BA/BE Process Flow

2,439 views

Published on

Timelines, Regulatory Process

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
2,439
On SlideShare
0
From Embeds
0
Number of Embeds
17
Actions
Shares
0
Downloads
59
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Presentation - Phase 1 & BA/BE Process Flow

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

×