Pharma Data Management
At Eurofins Central Laboratory, each study we conduct is set up in our global Laboratory Information Management System (LIMS) to enable fully automated analysis within the laboratory and throughout the entire process. Maintaining one global LIMS allows enhanced standardization, set-up and control. The set-up is based on the study-specific laboratory protocol and defines the planned visits and tests, reporting parameters, results calculations and study-specific flags. QC-procedures, including peer review and dummy test runs, are also applied.
By deploying one global database, all critical information is readily available to each project manager at every Eurofins Central Laboratory location.
Electronic Data Transfer
Eurofins Central Laboratory has a wealth of experience in providing electronic data to clients. Data can be delivered in ASCII or SAS data files in various formats, e.g. CDISC lab data model, Eurofins standard data transfer format, or a format defined by the client. Custom programming is performed according to customer requirements.
The frequency of EDT is planned at the beginning of the study and agreed with the client. The frequency can be daily, weekly, monthly or any other frequency as required. Files can be transferred, encrypted if required, via email, or directly posted on a customer web portal. All aspects will be documented in the electronic data transfer specifications, agreed upon and signed by client and Eurofins Central Laboratory.
With a distinct Data Analytics department [in addition to from Data Management], we assign a dedicated Data Analyst to each protocol at award. Our philosophy is that all activity engaged in support of clinical trials, is in pursuit of achieving validated and qualified data results. We believe each protocol presents unique opportunities in the management and analysis of the data generated, ultimately assisting with quality of operations, accuracy of final database and ability to achieve study timelines.
The Data analysts’ responsibilities include conducting full life cycle data analysis on studies, maintaining dashboards, identifying trends and monitoring activity in quality and performance to inform the Project Manager, and enabling them to make informed decisions. All studies will have a Data Analyst assigned at award, and Data Analyst becomes part of the study team.
Eurofins Central Laboratory is pleased to showcase our innovative Study Dashboards and Project Status Reports (PSR). With these tools, both our Project Managers assigned and responsible for the successful conduct of your clinical trial and your assigned Clinical Teams, have access to following standard study operational reports/tools : Lab Kits Supplied, Lab Kits Available (assumed), Specimens collected and shipments, Sample Location, Samples in storage and tested, Sample quality (lost data), Open and escalated queries, Invoices issued, Budget status, Panic alerts issued, Site compliance trends, and Financial Forecasting.
For our Preferred Partner relationships, we are always interested in exploring unique and creative reporting metrics, to assist with study conduct, proactively address trends prior to becoming problematic and provide actionable insight into site behavior that could indicate additional training requirements. Our industry leading professionals in Project Management would be eager to start the discussion and showcase how these tools can ensure successful outcomes with your clinical trials programs.
Each study is set up in our Global Results Database which is accessible through our Fetch Data Portal to enable data consistency and standardized reporting. The real-time system allows standardized global reporting of laboratory data to Sponsors and CROs, as well as the production and organization of management reports. The main purpose of our Fetch Data Portal is to provide 24-hour, secure access to authorized data reports and clinical trial information. Different access levels are deployed to accommodate Sponsors, Monitors and Investigators. In addition to the Standardized Reporting Tool, several Management Reports and Query Tool Reports are also available.
For any third party laboratory that would be subcontracted directly by Eurofins Central Laboratory, we take full responsibility for the performance and output of that laboratory, including data results. They would be incorporated into our cumulative “Data Lake” model, and presented as one comprehensive data transfer to our Clients.
In addition, by utilizing the services of our assigned Data Analyst to each protocol, we have the ability to integrate third party data generated from Sponsor EDC system (i.e. Patient demographics) and specialty laboratories directly contracted by Sponsor.