Accelerating Cycle Times with External Data Management Best Practices

A decade ago, an average phase 3 study collected around a million data points. Nowadays, according to Tufts, that same late phase trial involves approximately 3.5 million data points, and this volume is rising fast. At the same time, with ongoing technology advances and decentralization, trials are now incorporating an ever-increasing variety of data types and sources collected outside of traditional electronic data capture (EDC) systems. This volume and variety, combined with growing data velocity, brings transformational opportunities for richer patient insights and more efficient clinical development. However, the proliferation of external data brings accompanying challenges of standardization, reconciliation and more complex vendor collaborations. In the face of this continual change, organizations must take a strategic approach to collecting, process and managing external data.

To navigate these challenges and opportunities and enable clients to maximize the value of new data sources, eClinical Solutions has established a dedicated Center of Excellence for External Data. The Center of Excellence serves as a centralized hub within eClinical Solutions’ Biometrics Services team to oversee external data capabilities, and establish standards, optimize processes, and foster collaboration with internal teams and external stakeholders.

In a Biometrics Academy webinar, Mary Bailey, Director of Clinical Data Management, and Cassandra Leary, Manager of External Data, shared best practices and initial outcomes gained from the Center of Excellence’s inception. In this blog, we review some of their insights, and share the recording from the webinar.

People

The first key step in establishing the Center of Excellence, was appointing an external data SME (Subject Matter Expert), Cassandra Leary, to lead the initiative and disseminate knowledge across the wider eClinical organization. Cassandra is building and training a team of laboratory data and external data specialists, while fostering alignment across data acquisition, data management and biostatistics functions to streamline processes and drive meaningful insights.

Processes

Continual process improvement with respect to vendor management and standardization are integral to the Center of Excellence for External Data’s mission. Key initiatives include developing CDISC-driven data transfer agreements for each data type to ensure that the collected data is properly structured and handled. These ongoing standardization efforts help to streamline data reconciliation and cleaning, while ensuring comparability and accurate analysis.

Technology

The team leverages elluminate^® to enable efficient data ingestion, transformation, processing, and analysis of all data types, while dashboards and visualizations seamlessly highlight key trends, patterns, and outliers to enable informed decision-making. As part of the Center of Excellence roadmap, the team is developing customized functionality to track key performance indicators (KPIs) within elluminate and enable efficient management and oversight of multiple external data vendors.

Outcomes

A focus on external data is already yielding beneficial outcomes for the Biometrics Services team, with a reduction of up to 60% in the time needed for external data reconciliation, and accelerated database locks. The team has also benefited from more transparent ownership of vendor management processes, deeper collaboration, and ongoing guidance from subject matter experts. The foundation of good practices allows the cross-functional team to optimize external data management for the current portfolio of trials while preparing for the future state, by anticipating the needs of sponsor organizations in a modernized clinical trial landscape.

To learn more strategies for streamlining end to end external data handling, click below to watch Mary Bailey and Cassandra Leary’s webinar, “Maximizing the Value of External Data”.

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