Driving technology and processes for better data management outcomes

Biometrics Services Spotlight Series | Q&A with Robert Altman

As we continue our Biometrics Services Spotlight series, we talk with Robert Altman, Director of Data Management at eClinical Solutions for further insights into how our clinical data management services team is working to support clients in an ever-evolving and increasingly data-centric environment.

In his role, Robert develops biometrics best practices and manages a team of portfolio leads overseeing delivery and driving data efficiencies and standardization. In our interview we discuss the importance of oversight, the technologies having the greatest impact in data management today, and the role of the portfolio lead within eClinical Solutions’ Biometrics Services.

What’s your role at eClinical Solutions, and what’s your background?

As a Director of Data Management, my role today reflects my career experience driving functional improvements through resourcing, process, technology, training, and mentoring across the data management team. At eClinical Solutions, we assign portfolio leads to provide oversight, expertise, and identify and implement efficiencies across multiple studies for a single sponsor. One of my responsibilities is to oversee that team.

Over the course of my career, I have worked for several sponsors and led the transition of processes from paper-based activities to EDC (Electronic Data Capture). While working within the services space, I’ve been part of the continued evolution to a digital model, and now towards decentralized trials. My experience also includes running Functional Service Provider (FSP) engagements for data management, statistics, and statistical programming.

What would you say are the most notable developments you’ve seen in recent years in, in data management across your career?

That initial transition towards EDC was of course a significant milestone. Now with decentralization and increasing patient centricity we see a step change in data volume, speed, and variety which clinical data management groups will need to handle.

Let’s take wearables as an example. That data is being transmitted in near real time –it’s reams and reams of data in significant volume. As a data-centric organization, through our technology and our biometrics services we are well placed to be at the forefront of taking that data and making the most sense out of it for our clients, to help them make better-informed, real-time decisions.

Over your career what’s surprised you most about how data management has evolved?

So, before risk-based quality management came to the fore, we had risk-based monitoring, and from my perspective, the adoption of that methodology seemed to be slow. I’m using this as an example of how, more generally, either for the uptake of a process or technology, – or both, the industry prefers to take a conservative approach – like dipping a toe in the water. This is understandable given the regulatory framework and compliance focus of our industry. However, we also need to be mindful that the data environment is changing extremely quickly, and data is going to be rushing in like a tidal wave.

Handling it all needs different tools and methodologies than simple edit checks. Instead, as data managers, we will need to be looking closely at analytics and trends. To achieve faster adoption of the new approaches for this changing environment, we need to continue to demonstrate their value and importance.

You mentioned that you work extensively with our portfolio leads. Can you tell us a little more about the portfolio model and how it bolsters delivery?

Oversight is critical to ensuring high quality deliverables and is also a regulatory obligation for the sponsor. As subject matter experts, our portfolio leads not only oversee quality, but also pinpoint other issues and enable the client to get ahead of them. There’s a value simply in overseeing the program of studies for a given client and acting as an extra set of eyes.

The portfolio leads apply their specific expertise in biometrics and in clinical trials but take a bird’s eye view in considering the studies from data collection to analysis. Their role helps to squeeze out any workflow bottlenecks, manage standardization and drive efficiencies across the portfolio.

What technology advances have untapped potential?

We are becoming increasingly efficient at making sense of disparate data from this greater variety of sources. There is still potential to increase the breadth of that data that we can handle as an industry through technology and services and become even more efficient at doing so. There are also untapped opportunities to streamline execution of decentralized and hybrid types of trials.

The other area of potential that particularly applies within larger-scale engagements such as FSPs (Functional Service Provider) is improving oversight capabilities for sponsors through technology and processes. Enabling sponsors to show oversight of KPIs (Key Performance Indicators) and milestones as well as data quality oversight and show evidence of that to a regulator is extremely valuable. These tools and technologies are invaluable for the sponsor directly, but also for the portfolio lead who can more easily oversee the trials and bring issues to the client’s attention. This combination of technology with the portfolio lead approach I’ve described helps to keep everyone on the same page.

In your view, what are the key differentiators of our biometrics services?

We eat, breathe, and sleep data! With clinical development becoming so data-centric now, that holds a lot of value for our clients. Good data management means data quality, data integrity and keeping that focus on the end-to-end data stewardship. With the ability to handle greater data volumes and variety we’re also at the forefront of shifting from a traditional clinical data management role towards clinical data scientist capabilities.

My aspiration for our group is to continue being best in class in helping sponsors to navigate the new data environment with proven tools and methods to get to the best insights and outcomes.

About Robert Altman