Central Laboratory Services
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High-Quality, Global Central Laboratory Data
Covance Central Laboratory Services provides global laboratory data collection, management and near real-time data access. We develop a customized, protocol-specific and centralized database according to your protocol specifications. This global, centralized database enables you to obtain faster test results and greater consistency.
Our comprehensive, global laboratory data management system provides:
- A bar-coded specimen collection and storage capability ensures all specimens received from our visit-specific patient kits are tracked, resulted, stored and reported
- Specimen validation includes stability (time); condition (received ambient, refrigerated, or frozen; broken in transit); specimen identification and correct container or specimen type; and a check of appropriate specimen volumes for testing and retesting (if necessary)
- One global combinable data set enables you to minimize data manipulation at study close and facilitate rapid data transfer and analysis
- Near real-time access to the laboratory testing results of your specimens via LabLink
- Access to raw data (requisitions, laboratory instrument printouts, laboratory information systems worksheets, project files, and documentation for software change control and validation), which are stored for 20 years after the end of the study — electronic data is stored indefinitely.
Worldwide Laboratory Operation Services
To ensure global data integrity by all Central Laboratory sites and adherence to the same quality control standards, Covance created a dedicated department, Worldwide Laboratory Operation Services (WLOS). WLOS is responsible for establishing worldwide uniformity for each protocol-specific database, ensuring data combinability through test correlations and statistical evaluation of data accuracy and precision.
Laboratory Reports
The Covance Central Laboratory reporting system offers clients flexibility in customization while meeting their protocol-specific needs. For most analytes, we deliver reports to investigator sites within 48 hours of the patient visit. Based on your protocol needs and budgetary considerations, we also have the capacity to fax reports to you or investigator sites within 24 hours of the patient visit.
All of our patient laboratory reports:
- Include patient demographic data
- Contain the clinical trial reference range associated with each analyte
- Contain specimen collection information
- Include additional patient or administrative information collected on the requisition, if requested by clients
- Are bar-coded to ensure accurate report delivery
- May be designed to prompt the investigator for signature and comments
- May be written to allow clients to define flagging terminology
- May be customized to match clients' case report form format
- May be delivered on a scheduled day of the week that best suits your schedule
- May be sorted in the order of investigator and patient to facilitate review
- Can be offered as a laboratory cumulative report.
Patient laboratory reports can be delivered any way you want: via fax, courier, presorted by investigator or project, or scheduled for your specified frequency.
In addition to patient laboratory reports, patient enrollment and test abnormality reports can be provided.
LabLink: Web-based Laboratory Data Access & Reports
As a Covance customer, you have access to LabLink, a Web-based tool that enables you to achieve 24/7 near real-time access to your laboratory data — anytime, anywhere in the world via our secure site.
Through simple navigation, LabLink offers electronic review and downloading of central laboratory information without the need for additional hardware, software or modems. Covance offers this secure, standard service for unlimited users within your organization so critical decisions can be made in real-time.
LabLink features:
- A secure Internet connection that protects data from unauthorized access and eliminates the need for additional hardware, software or modems
- Access to near real-time global data for unlimited users within your organization
- Electronic review and downloading of protocol-specific data to monitor patient safety and manage day-to-day protocol activities
- An online user manual or help desk support
- Delivery of standard and customized reports to assist in managing enrollment, safety and efficacy trends, and protocol compliance.
LabLink allows you to:
- Review global results in near real-time once specimen analysis is completed in the laboratory
- Eliminate the need for additional hardware, software or modems through a secure internet connection
- Eliminate stacks of disconnected lab reports to review after site visits
- Review historical data for any parameter of interest electronically
- Make faster "go/no-go" decisions.
Data Transmissions
Covance Central Laboratory Services provides flexibility in electronic data reporting. The file format is defined by the sponsor and prepared by the Covance Central Laboratory Services data analyst in accordance with the formal data transmission agreement. A sample format is provided to the sponsor for review and approval. The file transmission delivery frequency, media and desired format are defined in the data transmission agreement. Any translations required between Covance Central Laboratory Services specific terminology and customer specific terminology are also outlined in the data transmission agreement. Our project management, data management, and medical affairs personnel will work closely together to ensure data integrity is maintained for any requested translations.
Covance Central Laboratory Services data transmissions can be established as direct electronic transmissions with security levels that meet FDA data submission requirements. Our data transfers are compatible with industry standard databases such as Oracle Clinical and SAS.
Data Revisions
Covance Central Laboratory Services data revision reports document changes in specimen testing results or patient or administrative information after the laboratory report has been issued. The revisions are printed in an easy-to-read format. The report identifies the affected data element(s), both before and after revision, and documents the change authorization, contributing to easy identification of the revised data element for updates to the Case Report Form.
Leadership in CDISC Data Reporting
The Clinical Data Interchange Standards Consortium (CDISC) is an open, multidisciplinary, non-profit organization committed to the development of industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The mission of CDISC is to lead the development of global, vendor-neutral, platform independent standards to improve data quality and accelerate product development in our industry.
Covance Central Laboratory Services is a founding and active member of the CDISC Laboratory Data Team, whose task is the development of laboratory data interchange models and standards. Covance Central Laboratory Services successfully completed our first CDISC LAB test data transmission in 2001 and our first production data transmission in early 2003. Covance Central Laboratory Services has successfully transmitted standard laboratory data in file formats based on the current production release of the CDISC Lab model for over 22 pharmaceutical and CRO customers around the world.
Covance offers the following CDISC Laboratory Model services:
- CDISC LAB version 01-0-01 compliant ASCII, SAS and XML formats via our clinical trials data transfer software
- LOINC coding service is available on request
- CDISC and HL7 recommended code lists available in all formats.
Covance is a proud sponsor of the CDISC organization. |
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