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Best practices and communication to streamline data management delivery

Biometrics Services Spotlight Series | Q&A with Mary Bailey

In our latest Biometrics Services Spotlight blog, we sit down to talk with Mary Bailey, Director of Data Management at eClinical Solutions. With over 25 years’ experience in global clinical data management, Mary’s vital role within the eClinical Solutions data management team encompasses strategic direction, process optimization and people development.

In this wide-ranging discussion, Mary shares her insights on the challenges and opportunities ahead for leaders, best practices, and the vital importance of communication and collaboration in successful end-to-end delivery.

Tell us a little about your role at eClinical Solutions and your career in data management so far.

My degree is in Nursing, and after graduation, I spent 7 years working in Cardiac and Urgent Care. This experience provided me with a solid clinical background before making the move into data management over 25 years ago. I’ve worked at eClinical Solutions for three years, initially joining as a manager before transitioning to my current position of Director.

My role spans several core areas, including managing and training the Data Management delivery team, acting as a subject matter expert (SME) providing strategic input and direction to the group, and collaborating closely with internal and external stakeholders to ensure optimization of our standards, technologies and processes.

I really enjoy working with the people here. It’s a collaborative environment, that embraces new ideas and ways of working, so I always feel like I’m making a difference.

What are the biggest challenges and the most promising opportunities facing the industry now?

Ten years ago, a typical Phase 3 trial had about a million data points. By contrast, a Phase 3 study today has around 3 1/2 million data points – a staggering three-fold increase.  With expanding use of wearables and other technologies in clinical trials, data may be incoming almost continuously- 24 hours a day, seven days a week. This exponential growth in data volume, variety, and speed brings challenges for biometrics groups who need to efficiently manage and analyze that data while ensuring its quality. But as well as challenges, data availability also presents promising opportunities for generating better insights, that we can unlock through technology and advanced analytics.

In my view, our top priority as biometrics leaders is to create and implement strategies for handling this influx of data that the traditional data management model simply cannot handle. By planning carefully, and leveraging technology, we will be well positioned to maximize the potential of data growth. As a biometrics services team, we are fortunate to have access to elluminate®, which allows us to consume, aggregate, clean and analyze data from any source. It helps us enormously to work with every data source within a single platform, allowing us to normalize that data and look at the bigger picture. Through elluminate, we benefit from the increased collaboration across our biometrics functions internally, and the sponsors we work with are also empowered to look across the data in real time while overseeing the work we are doing.

Risk-based approaches are a vital aspect of our evolving data management toolkit, enabling us to examine large amounts of data in real time and look for trends, to identify and act on problems early and increase patient safety and efficacy.

Other promising opportunities that we are adopting into our practices at eClinical Solutions are artificial intelligence and machine learning, which allow us to analyze large volumes of data and pick up on significant trends and patterns more quickly.

Human oversight is still critical, but these innovative technologies and processes are highly beneficial. Reflecting on when I started out in data management, working with paper CRFs, I could not have imagined in my wildest dreams the advances that have been accomplished. And it’s satisfying that these advances will all ultimately help patients.

With increased complexity and fast-paced trials, how can data management leaders ensure better outcomes? What best practices do you deploy?

For me, the first step in any successful clinical trial is to start with the end in mind. As Data Managers, we must have a clear strategy and plan for the whole trial from build to database lock. That cohesive plan should include clear timelines, budget constraints and data objectives.

It’s a given that robust processes and standards enable efficiencies and improve data quality. To handle the growing variety of external data, we are building on standardization of Data Transfer Agreements, creating standards for each specific data type as far as possible. In the light of growing external data volume, good practices for vendor management are increasingly important. Streamlining integration using elluminate’s Data Central, and ensuring security are also vital components of a strong data strategy.

One notable initiative we have been able to implement recently through our accreditation with Medidata Site Cloud (End of Study), is to automate many of the tasks associated with the close out process and cut the time-consuming creation of physical materials. Now, what used to take weeks or months is done in a matter of days.

What role does communication play in successful delivery?

Involving internal and external stakeholders from the outset ensures that everyone feels heard and understands the goal of the study and their roles in meeting timelines and deliverables. Any operational plan must include a communication plan detailing the methods and cadence of communication – which can be tailored to individuals’ preferences. Escalation pathways lay out the process in case of issues or absence of a team member, while the use of technology like elluminate can also facilitate better communication and faster resolution of issues.

Organizational silos can cause data inconsistencies, so breaking down any silos through collaboration and cross-functional alignment creates greater consistency and standardization. At eClinical, our data acquisition, data management, and biostatistics groups are closely aligned from the start of any project. When all external and internal stakeholders are pulling together well towards a common goal, efficiency increases.

To read more insights on data trends, challenges and opportunities, download our 2023 Industry Outlook.


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