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Qualification of a Central Lab for a Clinical Trial

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Qualification of a central lab for a clinical trial.

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Qualification of a Central Lab for a Clinical Trial

  1. 1. Qualification of a Central Lab for Clinical Trial Russian Clinical Trials Forum 2016 November 9-10, 2016
  2. 2. Content • Introduction: Central Lab Role in Clinical Trials • Decision Criteria: • Range of Services • Experience and Expertise • Quality System • Additional Services Requirement
  3. 3. Lab Data in Clinical Trials* Efficacy Data • e.g. Cholesterol level in Hyperlipidemia patients • e.g. Plasma Glucose in Diabetes patients Safety Data • Hematology • Chemistry • Urinalysis Special Data • PK/PD data • Genomic data • Biomarkers *60-80% of the data generated during the conduct of clinical trials are produced by laboratories
  4. 4. Lab Types in Clinical Trials Central Lab One central location Local Lab in close proximity to individual clinical study sites Virtual Central Lab group of labs across world under the umbrella of one company Core Labs Lab tests, ECG, imaging e.g. cardiovascular core lab Analytical Labs non-traditional tests (biomarkers, PK, genetic) Traditional Testing Specialty Labs
  5. 5. Central Lab Role in Clinical Trials Project Management Laboratory Testing Investigator Support Sample Management Logistics Data Mgmt and Reporting • Routine and safety analysis • Advanced diagnostics • Method development and validation • Analytical expertise • Dedicated and locally based staff • Real-time query resolution • Trainings • Multilingual help desk • Lab manuals and instructions • Study-specific kits building • Packaging and labels • Quality Control • In-house frozen logistics support • Kits inventory monitoring • Planning, tracking and reporting • Ambient, refrigerated, frozen and combo shipments • Ready shipping documents • Couriers management • Network of own couriers • Integrated single database • Standardized reference ranges and units of measure • Electronic Data Transfer • 21CFR Part 11 – compliant reporting technology Full Coordination and Accountability
  6. 6. Services: Laboratory Testing • Safety and Routine: • Biochemistry and Immunochemistry, Hematology, Urinalysis, Serology • Biomarkers • Genotyping (DNA/RNA extraction) • PK / PD • Microbiology • Method development
  7. 7. Services: Central Lab • Documentation: • Analytical Plan, Lab Manual • Laboratory kits • Sample Management • Logistics • On-line reporting • Data Management • Biorepository • Equipment rent
  8. 8. Services: Geo Coverage • Local: Single country • Regional: Europe • Global
  9. 9. Project Team Organization Lead Project Manager Country/Region Project Manager CRC Kits builder specialist CTA CRC Sample reception specialist CTA Back-up Project Manager Country/Region Project Manager CRC Kits builder specialist CTA CRC Sample reception specialist CTA Back-up Project Manager Back-up Lead PM *CVs available on request
  10. 10. Experience • Clinical trials: • Employees: • Years of experience • Retention and turnaround • Education • Trainings Clinical area Number of samples Number od studies
  11. 11. Quality Assurance High-quality services ISO15189:2007 qualitystandards SOPscompliant withGCPandGCLP ExternalQuality AssurancePrograms InternalQualityControl Keysuppliersaudit Client audits are welcome
  12. 12. Accreditations (must) • WHO GCLP • EN ISO 15189 • Local registration
  13. 13. Certifications (nice to have) • GCP for employees • EN ISO 9001 • EN ISO 27001
  14. 14. Standard Operating Procedures • Polices and Plans • General • Quality Assurance • Project Management • Logistics • Laboratory • IT General: • Quality System Documentation • Organization and Personnel • Trainings • Project Documentation • Documentation Archiving • Selection of Subcontracted Laboratories • Vendor selection (non-laboratories) • Management review • Supply Chain Management • Customer satisfaction
  15. 15. Standard Operating Procedures • Polices and Plans • General • Quality Assurance • Project Management • Logistics • Laboratory • IT Quality Assurance: • Quality Assurance • Audits • Resolution of non- compliants and corrective actions • Quality Control
  16. 16. Standard Operating Procedures • Polices and Plans • General • Quality Assurance • Project Management • Logistics • Laboratory • IT Project Management: • Study Procurement • Study Setup • Study Conduct • Study Close
  17. 17. Standard Operating Procedures • Polices and Plans • General • Quality Assurance • Project Management • Logistics • Laboratory • IT Logistic: • Laboratory Kits • Clinical Samples Transport • Storage of clinical samples • Equipment • Facility and Environment
  18. 18. Standard Operating Procedures • Polices and Plans • General • Quality Assurance • Project Management • Logistics • Laboratory • IT Laboratory: • Preanalytical Procedure in clinical trials • Sample flow in laboratory • Postanalytical Procedure in clinical trials • Communication with co- operating laboratories • Laboratory Data Harmonization and reporting standard with the Network of Labs
  19. 19. Standard Operating Procedures • Polices and Plans • General • Quality Assurance • Project Management • Logistics • Laboratory • IT IT: • System characteristic and requirements • System set-up and installation • User acceptance testing • Problem management • User support • System back-up and restoration • Data Management • System security • System use and maintenance • Change management • Disaster Recovery
  20. 20. Audits • External • Regulatory Authorities & Bodies • Accreditations & Certifications • Clients • External Quality Assurance Programs • Internal • Periodic internal audits • Key suppliers periodic audits
  21. 21. Kits Inventory Monitoring • Monitoring of the kits expiration date • Informing the sites before kits reach expiration date • Management of kits/materials re-supply
  22. 22. Kits Inventory Monitoring
  23. 23. Kits Inventory Monitoring
  24. 24. Samples Tracking • Tracking of shipments from the sites to the regional central laboratories • Inventory of samples stored at regional hubs – data accessible via web-based application – LabOne • Immediate action in case of delays, missing, destroyed or other problems with the samples
  25. 25. Samples Tracking
  26. 26. Samples Tracking
  27. 27. Online access to results • Proprietary software 21 CRF part 11 compliance • Web-based and secured • Real-time & 24/7 access • Color-coded results • Reporting: • Cumulative or incremental • Abnormal • Trends • Custom
  28. 28. Online access to data
  29. 29. Online access to data
  30. 30. Online access to data
  31. 31. Data Management • Data Transfer Protocol • Database set-up and validation • Test of Data Transfer • Verification and Validation of Data • Transfer of Validated Data • Database cleaning • Final Database transfer
  32. 32. Electronic Data Transfer Data formats - ASCII data files - CDISC format - Client specified format Transfer methods - Directly into eCRF - Sponsor FTP server - Couriered CD - Secure email attachment file Reports - Patient recruitment - Abnormal results - Missing patients visits - Parameter trend analysis Integrated Single Database
  33. 33. Biorepository Services • Sample storage capabilities: (-20°C, -80°C, liquid nitrogen) • Regional hubs location • Centralized samples management and tracking • Safety samples remainders storage at -20°C (serum, plasma, urine) till the end of project.
  34. 34. Biorepository Services • Sample storage of PK samples in -80°C • Regional hubs: Poland, Ukraine, Russia • Centralized samples management and tracking • Safety samples remainders storage at -20°C (serum, plasma, urine) till the end of project.
  35. 35. Biorepository Services • Sample storage of PK samples in -80°C • Regional hubs: Poland, Ukraine, Russia • Centralized samples management and tracking • Safety samples remainders storage at -20°C (serum, plasma, urine) till the end of project.
  36. 36. Biorepository Services • Sample storage of PK samples in -80°C • Regional hubs: Poland, Ukraine, Russia • Centralized samples management and tracking • Safety samples remainders storage at -20°C (serum, plasma, urine) till the end of project.
  37. 37. BRUSSELS HQ Questions? Oleksii Gaidamak, MD Director, Synevo Central Labs Belarus, Ukraine, Russia, Georgia T: +38 067 000 13 03 E: oleksii.gaidamak@synevo.eu

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