Qualification of a Central Lab for a Clinical Trial
-
Upload
michal-dysko -
Category
Health & Medicine
-
view
200 -
download
1
Transcript of Qualification of a Central Lab for a Clinical Trial
Qualification of a Central Labfor Clinical Trial
Russian Clinical Trials Forum 2016November 9-10, 2016
Content
• Introduction:Central Lab Role in Clinical Trials
• Decision Criteria:• Range of Services
• Experience and Expertise
• Quality System
• Additional Services Requirement
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
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
Central Lab Role in Clinical Trials
Project Management
Laboratory Testing
Investigator Support
Sample Management
LogisticsData 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
Services: Laboratory Testing
• Safety and Routine:• Biochemistry and Immunochemistry,
Hematology, Urinalysis, Serology
• Biomarkers• Genotyping (DNA/RNA extraction)• PK / PD• Microbiology• Method development
Services: Central Lab
• Documentation:• Analytical Plan, Lab Manual
• Laboratory kits
• Sample Management
• Logistics
• On-line reporting
• Data Management
• Biorepository
• Equipment rent
Services: Geo Coverage
• Local: Single country
• Regional: Europe
• Global
Project Team OrganizationLead Project
Manager
Country/RegionProject
Manager
CRC
Kits builderspecialist
CTA
CRC
Sample receptionspecialist
CTA
Back-up Project Manager
Country/RegionProject Manager
CRC
Kits builderspecialist
CTA
CRC
Sample receptionspecialist
CTA
Back-up Project Manager
Back-up LeadPM
*CVs available on request
Experience
• Clinical trials:
• Employees:• Years of experience• Retention and turnaround• Education• Trainings
Clinical area Number of samples Number od studies
Quality Assurance
High-quality services IS
O 1
51
89
:20
07
qu
ali
ty s
tan
da
rds
SO
Ps
co
mp
lian
t w
ith
GC
P a
nd
GC
LP
Ext
ern
al Q
ua
lity
As
sura
nc
e P
rog
ram
s
Inte
rna
l Q
ua
lity
Co
ntr
ol
Ke
y s
up
pli
ers
au
dit
Client audits are welcome
Accreditations (must)
• WHO GCLP
• EN ISO 15189
• Local registration
Certifications (nice to have)
• GCP for employees
• EN ISO 9001
• EN ISO 27001
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
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
Standard Operating Procedures
• Polices and Plans
• General
• Quality Assurance
• Project Management
• Logistics
• Laboratory
• IT
Project Management:
• Study Procurement
• Study Setup
• Study Conduct
• Study Close
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
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
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
Audits
• External• Regulatory Authorities & Bodies• Accreditations & Certifications• Clients• External Quality Assurance Programs
• Internal• Periodic internal audits• Key suppliers periodic audits
Kits Inventory Monitoring
• Monitoring of the kits expiration date
• Informing the sites before kits reach expiration date
• Management of kits/materials re-supply
Kits Inventory Monitoring
Kits Inventory Monitoring
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
Samples Tracking
Samples Tracking
Online access to results
• Proprietary software21 CRF part 11 compliance
• Web-based and secured
• Real-time & 24/7 access
• Color-coded results
• Reporting:• Cumulative or incremental• Abnormal• Trends• Custom
Online access to data
Online access to data
Online access to data
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
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
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.
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.
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.
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.
BRUSSELSHQ
Questions?
Oleksii Gaidamak, MDDirector, Synevo Central Labs Belarus, Ukraine, Russia, GeorgiaT: +38 067 000 13 03E: [email protected]