Bringing Your External Data Into the Fold

As the volume, variety and velocity of clinical data continues to expand, data managers are spending more time managing external data sources, combining it with other data sources, and visualizing data holistically to spot outliers and identify quality issues. The majority of clinical trial data now comes from external or non-EDC data sources, and the eClinical Biometrics Services team sees life science companies working with an average of 10 unique data sources per trial, a 25% increase from two years ago and an even greater increase in the overall volume of data.

The role of clinical trial data management has changed greatly in recent years. Data managers now spend more time on defining data flows and data strategy across the trial, working with data providers on specification and standards, and ensuring consistency while avoiding duplication across sources. Setting up and managing external data providers and sources along with integrating and reconciling these data and the data review function has become more complex and more critical to trial success.

This elluminate Academy webinar will highlight best practices and lessons learned for using the elluminate Clinical Data Cloud to effectively manage all your data sources. Best practices for acquiring, managing, and reviewing external data sources will be discussed, as well as the metrics to track and results that can be achieved from building an external data center of excellence and mindset within the data management function.

In this webinar, data leaders will learn how to:

• Define specification and data transfer formats for external data providers
• Develop strategies for testing and timelines to keep all providers on track
• Establish data cleaning best practices
• Optimize the elluminate Clinical Data Cloud for external data ingestion and review with Data Central

Watch the recording

Who Should Attend

• Data Management
• Clinical Programming
• Medical Monitoring
• Clinical Informatics
• R&D IT

Presenters

Diane Lacroix

Vice President, Clinical Data Management, eClinical Solutions

Diane Lacroix is a data management professional and leader with over 20 years in the pharmaceutical/CRO industry. As VP, Clinical Data Management at eClinical Solutions, Diane is responsible for leading the data management function including building effective process and implementation strategies to ensure that clients receive maximum value and quality from the elluminate driven data services that Diane’s team delivers. Diane’s career in data management has included numerous leadership roles both at service providers and on the sponsor side. She has worked on all aspects of global trials from study start-up through to database closure and submission leading and managing successful teams and projects to ensure high quality and on-time delivery of clinical data assets. Diane has deep expertise in the oncology and rare disease therapeutic areas and in data management technologies including EDC (Electronic Data Capture) systems and integration and analytics technology platform like elluminate.

Mary Bailey

Director, Clinical Data Management, eClinical Solutions

Mary is a highly experienced professional with an educational and professional background in nursing and over 25 years in clinical data management. Mary has proven experience in the global data management of Phase I-IV trials of varying complexity across a wide array of therapeutic areas. As a Director of Clinical Data Management at eClinical Solutions, Mary is responsible for managing, developing, and coaching data management associates for continued growth within their roles, as well as overseeing direct data management functions ensuring timely and high-quality deliverables.