Developing an Effective, Time-Saving Clinical Data Review Strategy
eClinical Solutions hosted a live Centerwatch webinar that examined today’s current data chaos environment and how to implement an effective clinical data platform to improve data quality and access, as well as positively impact cycle times. The webinar featured eClinical experts Angela Slocum, Senior Director of Implementation Consulting, and Mitesh Devarapally, Principal Medical Data Reviewer. Their presentation outlined the key elements of developing a strong clinical data strategy and included a demonstration of eClinical’s elluminate® Clinical Data Platform.
Accelerating Clinical Data Review
As clinical data has grown into the complex and varied tidal wave of information facing drug development today, it has subsequently made the management of data and clinical trial execution more challenging. It’s now more important than ever to make sure that your data review objectives are well-defined and to consider a risk-based approach to streamline your data review. All data isn’t created equal, and it’s important to keep any data not used immediately for analysis purposes at-hand as you never know what might become important later on. As Slocum explains, “The first exercise for a risk-based approach is to prioritize the data, determining what’s critical, what’s secondary and what’s tertiary, and aligning your data review strategy to that perspective.”
Once a solution has been established for how to pursue those data review objectives, they then need to be aligned with the specific technology you intend to use, and beyond that, aligned with specific roles or end users. When considering technology, Slocum believes that one of the fundamental principles to consider is if it has a foundation on which you can overlay your established data review objectives and execution solutions. To accomplish this, you need to aggregate your data effectively when it’s coming from a large variety of sources. If you can aggregate that data in a useful and meaningful way within one platform, it will enable you to have more control over the data and use it more purposefully.
Within the context of a cross-study review or a program-level review, the data aggregation component is key to your success. The elluminate platform ingests data from any source, in any format, and maps the data accordingly within the system. It offers you the ability to normalize that data by mapping it to SDTM standard format, which then allows you to combine data across studies and within a program. Specifically, elluminate Data Central provides a solution to needing and wanting access to raw data, being able to execute on listing review, having the ability to review outpatient profiles, and most importantly, marking data as reviewed. You can also easily communicate with your study team members using elluminate’s issue functionality.
Save Time with Data Visualizations
eClinical’s principal medical data reviewer, Mitesh Devarapally and his team look at data from a medical and scientific perspective and review for eligibility, safety and efficacy so that the data is ready to be analyzed and submitted to the statistics teams. By utilizing data visualizations provided in elluminate’s Clinical Data Analytics product, you can clearly see the current state of a specific study all on one dashboard. Whether you need to review enrollment, how many subjects have completed the study or what kind of adverse events have occurred, you can see it all with time-saving visualizations in the elluminate platform.
eClinical data managers and medical data reviewers continue to play an important role in the development of elluminate’s Clinical Data analytics, using their expertise in the field to contribute to what the visualizations look like and how they function. It’s their goal to make sure that the output of the data visualizations represents what our clients need on a daily basis to perform their jobs effectively. Defining your integrated data review strategy is critical as it serves as the roadmap for executing on your data review and cleaning objectives. Without a centralized data platform and workbench to support that strategy, your objectives will continue to be difficult to accomplish.