Innovative Approach to Streamlining the Reconciliation Process in Biomarker and Safety Lab Data Management
Sponsored by: Covance
- Lab Data Management
Date: 4 December
Time: 4PM London/11AM New York
Key considerations for the import, standardization, and reconciliation of external data
Sponsors expect clean, quality biomarker data delivered in a standard format and a timely manner, but biomarker data management differs in many aspects from clinical data management. As new tests and new vendors are added, standards must be developed responsively. A biomarker data management strategy must also consider the long-term storage of samples for later testing. Biomarker data are often sent after the clinical trial is complete – and standard study timelines often don’t apply. Many biomarker data endpoints are not necessarily driven by the clinical study report (CSR). Biomarker data management work processes need to be designed to meet these alternative deliverables.
The first half of the presentation will discuss the differences between biomarker data and safety lab data, along with the efforts required to integrate processes between the central lab and data managers. The subject matter expert will also discuss strategies related to the set up and data cleaning processes for biomarker and safety lab data management, with a focus on collaborative practices across clinical and lab teams.
The second half of this presentation will discuss a specialized approach and organizational structure that have been implemented to manage and reconcile biomarker data for 200+ trials and 900+ data transfers. Attendees will learn how a structured, yet flexible process can help manage different vendors across different studies, and align standards with sponsor’s requirements for receiving and analyzing biomarker data.
Please join this educational presentation to gain awareness about opportunities to overcome typical challenges with biomarker and safety lab data management, and to learn how strategic approaches can help sponsors become more efficient and reduce their overall costs for standardized, high-quality and timely data.
Senior Manager, Clinical Data Management
Theresa Abell has 39 years of experience in Clinical Data Management within pharma companies and contract research organizations (CROs) where she had a wide variety of leadership roles. Before joining Covance last year, she was director of data management at oncology CRO for 10 years. She now leads the Biomarker Team at Covance FSPx to oversee 34 team members as they build technology and develop processes for delivering clean data aligned to a sponsor’s unique requirements.
Strategic Data Integration Leader
With 18 years of experience at Covance Central Laboratory Services, Thierry leads a small team of analysts and experts to develop the strategies for strategic data innovation and deliver a roadmap for data-driven solutions applicable to data services. He focuses on global data management efforts, processes and metrics on data quality and standardization. Serving as functional data expert in strategic client interactions, Thierry helps sponsors understand their options for external innovative data solutions and platforms. He is a subject matter expert in data management, study management, project management, statistics and process excellence and holds additional certifications in CDISC SDTM theory and application, statistics and data analysis, and project management.
Key Learning Objectives
- Understand the key challenges facing biomarker data management
- Learn how biomarker data management differs from clinical data management
- Hear about strategic approaches to efficiently manage high volume of data transfers
- Learn about best practices to integrate data from central labs, external vendors and study sites