qualification of a central lab russian clinical trial forum nov2016

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

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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



• General



• Logistics

• Laboratory

• IT

Quality Assurance:


• Audits

• Resolution of non-compliants and corrective actions

• Quality Control



• General



• Logistics

• Laboratory

• IT

Project Management:

• Study Procurement

• Study Setup

• Study Conduct

• Study Close



• General



• Logistics

• Laboratory

• IT

Logistic:

• Laboratory Kits

• Clinical Samples Transport

• Storage of clinical samples

• Equipment

• Facility and Environment



• General



• 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



• General



• 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

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

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

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.

BRUSSELSHQ

Questions?

Oleksii Gaidamak, MDDirector, Synevo Central Labs Belarus, Ukraine, Russia, GeorgiaT: +38 067 000 13 03E: [email protected]

qualification of a central lab russian clinical trial forum nov2016

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