Evolving Data Management in an Era of Decentralization

Clinical Biometrics Services Spotlight Series | Q&A with Diane Lacroix

In this first blog in a new series, spotlighting the work of our Clinical Biometrics Services team, we sat down with Diane Lacroix, VP, Clinical Data Management at eClinical Solutions to explore how her team helps clients to tackle the toughest data challenges facing the industry, and her vision for the future. Our discussion encompasses the benefits of data-focused outsourcing, how we help clients fulfill their oversight obligations, and how technology is shaping a new model of data management.

Increasingly sponsors are turning to specialized outsourcing models to gain ‘best in breed’ solutions that meet the needs of their trials. How do you feel our clients particularly benefit from working with us as a data services provider?

Diane Lacroix: One of the key advantages of engaging with eClinical Solutions’ data services, is that our entire focus is on guiding the most critical asset of a clinical trial program – its data- from protocol to analysis and beyond to successful approval. As a specialized organization, our clients benefit from a greater depth of data expertise and focus on streamlining data processes. As well, we can attract and retain talented professionals interested in innovative data strategies. We combine that core focus with strong technology competency through data acquisition platforms such as Medidata Clinical Cloud, and elluminate Clinical Data Cloud – which we use to review and prepare data for client decision-making.

The close alignment between our data acquisition, data management, and statistics and programming teams means fewer hand offs, and we proactively build in workflow efficiencies for data collection and data handling. In fact, when we work with clients across portfolios on several studies, we consistently achieve time and cost benefits through standardization and knowledge transfer. In essence, we act as an extension of the sponsor team for ‘all things data’ and help them to grow their portfolios by providing their data management and statistical analysis capability.

Quality data is essential for sponsors to make educated quality decisions for their products. Nowadays, there is an even greater recognition of the importance of a robust data strategy not only for individual trials, but across entire trial programs, and portfolios.

Why are efficient data management and analytics increasingly vital in modern drug development?

Diane Lacroix: In the past, the model of site-centric data collection was key to clinical trials. Prior industry trends combined with the catalyst of the pandemic mean that this model has now shifted significantly. Data is of course still collected at sites, but more data is collected externally. According to a recent survey during our ENGAGE annual client meeting, 65% of sponsors were using 6 or more external data sources within their studies, so strategies to handle this data are top of mind for clinical leaders. It means a transition for data management groups from simply cleaning and handling data coming in from the sites to creating solutions that can manage all the workstreams for these different data types and sources.

Those solutions encompass both technologies such as elluminate, capable of centralizing data workflows, and data services which allow sponsors to leverage the full potential of these technologies and gain access to clean data more quickly to reduce cycle times.

With data sources ranging from external labs to DCT (Decentralized Clinical Trial) technologies, defining a set of edit checks across the board on every data point will become unsustainable. Technology and analytics are essential for homing in on data anomalies, missing data, and erroneous data to enable timely course correction.

How does our use of technology enable clients to fulfill their oversight requirements?

Diane Lacroix: Sponsors have regulatory obligations to conduct robust vendor oversight. However, many find this challenging, partly because the guidelines do not specify exactly how to achieve it. elluminate provides an exceptional capability to oversee how we are performing as a vendor through the technology. Clients can gain both operational progress oversight, and data quality oversight. For many clients we have set up workflows in elluminate that allow them to ‘get behind the scenes’ and review the data output that we are looking at.

The principle can be extended across vendors, so many clients use elluminate to oversee not only eClinical Solutions as the data services provider, but medical monitoring and clinical CROs. They tell me that they find it incredibly helpful to have this visibility through a single tool.

What are your expectations for the future of data management?

Diane Lacroix: The model will change- and is already changing- in line with the realities of clinical research. Collecting data at clinical sites is not going to disappear, but we can certainly expect the continued evolution of a hybrid model in which we are bringing more to the patient through wearable technologies and decentralized trial approaches. Similarly, while traditional site monitoring will remain, there is momentum towards central monitoring roles. I also envision enormous potential in deploying AI and ML technologies as ‘virtual data managers’ that can partner with our human data managers, enabling them to work more efficiently with the increasing volume of data.

The other shift ahead lies in risk-informed approaches that enable greater focus on the most critical data. The ICH E6 R2 guidance, which was published in November 2016, requires that the quality management system should use a risk-based approach and a ‘prioritized risk-based approach to monitoring clinical trials’. Similarly, the ICH E8 (R1) guidance addresses risk management as a key pillar of overall quality. Nevertheless, across the industry, the adoption of risk-based strategies is variable due to factors such as change management and internal alignment, which we explored recently in discussions during our annual ENGAGE client meeting. We recognize that this is an evolution which will take place over a period of time. In the meantime, in collaboration with clients, we are incorporating certain risk-informed approaches, supported by elluminate RBQM.

All these developments will necessitate an evolution of the data management role towards clinical data science or data stewardship, and an integrated end-to-end data strategy that encompasses site visits, external data, DCT data, source, and ePRO – the whole spectrum. Within my team, we have a well-developed internal training program that specifically accounts for the new skills required in this changing environment.