Driving Quality and Speed in Clinical Data Acquisition

Biometrics Services Spotlight Series | Q&A with Grant Williamson

In this second blog in our Biometrics Services Spotlight series, we sat down with Grant Williamson, Sr. Director, Clinical Programming at eClinical Solutions to explore the essential role his clinical database programming team plays in assuring data quality, accelerating cycle times, and the overall success of a clinical trial. We discuss how quality is built into the heart of our processes, how we help to mitigate common issues through smart data acquisition strategies, and the outsourcing models we use to fulfil our clients’ database build needs.

Can you tell us about your role at eClinical Solutions?

Grant Williamson: As Sr. Director, Clinical Programming, I manage our clinical database programming team, overseeing overall delivery and assuring quality. Naturally, a vital part of our is work building Medidata Rave EDC (Electronic Data Capture) databases and associated modules. Alongside these core activities, we continually evaluate what data acquisition means within eClinical and in the wider life sciences industry. For example, sponsors and service providers alike are keen to harness the potential of decentralized and hybrid trials for greater efficiency and patient engagement. While the rewards stand to be significant, there are process challenges to overcome, and navigating the emerging vendor ecosystem can be complex. With that in mind, we are developing capabilities and expanding our portfolio to continue to incorporate technologies that help our clients successfully execute their decentralized and hybrid trials. Our goal is to be the go-to, all-inclusive provider supporting the data aspects of digital trials.

In your view, what differentiates your team?

Grant Williamson: People are at the heart of everything. We are not only clinical database programmers, but also project managers and communicators who work collaboratively with our internal eClinical data services and elluminate^® software teams, and externally with our clients. A unique aspect of our approach at eClinical is that we assign a lead database programmer as a designated client contact from study start up to close out. This end-to-end approach streamlines communication and issue resolution for any database related issues that the client may have. We find our clients really appreciate this silo-free experience. More generally, across our team, soft skills as well as technical skills are considered essential, so our leads are expert delegators who are skilled at managing global teams.

As a dedicated Medidata provider for over 10 years , eClinical Solutions’ clinical programming and data management teams attract top talent who have previously enjoyed working with the Medidata platform, which deepens the available expertise.

From a technical standpoint, our commitment to the Medidata platform results in an exceptional command of its full functionality across modules, and our ability to customize as needed. This deep expertise gives both flexibility and quality outcomes for our clients.

We also stand out in our approach to architecting a database. Our entire team is protocol trained, and able to translate the protocol directly into an eCRF rather than working from pre-written specifications. This saves time at project kick-off, and often reduces the oversight burden for sponsors because they don’t need to spend time in an extensive review of specifications. Instead, we spec as we build which streamlines the entire process.

How does your team help to influence the success of clinical trials?

Grant Williamson: A robust clinical database is an essential cornerstone of any trial and our goal as a team is to ease downstream activities by constructing a database that ensures clean, fit for purpose data. For sponsors, achieving speed and quality is paramount.

When we are working with a client across several studies or programs, our role is extended further. In this scenario, the assigned lead database programmer for that client would act as the overall primary point of contact for oversight, quality and delivery of that program. I often think of this role as acting as a technical architect at a program level.

In such a fast-paced environment continuous improvement of our processes is a must. One of our team members recently said that we cultivate an environment of innovation and experimentation. It’s true that giving our people time to work out better ways of doing things helps us to stay on top of our game. For example, we are expanding use of automation within our day-to-day process delivery which I feel sets us apart.

Grant’s top 5 success factors in clinical trial data acquisition

• Streamline communication during the build through consistent personnel assignment and process.
• Begin with the end in mind. Does the data collection answer the research question? Clinically trained database developers and close alignment with statistics groups help here.
• Be flexible. Every study has its unique challenges. Standardization is critical, but meeting the needs of increasingly complex trials often requires flexibility.
• Embed quality through processes, people and technology. Achieving quality while working at speed needs a multi-faceted approach with robust processes, expertise development and deep technology knowledge.
• Build efficiencies through standardization, long-term partnership and innovation. We know that by working in partnership with sponsors, we can achieve up to 60% savings in go-live timelines. These efficiencies are derived from strong partnerships and commitment to standards. Incorporating newer approaches like automation also streamlines delivery and adds value to partners.

What problems are clients facing with data acquisition?

Grant Williamson: Our recent industry survey on clinical data trends, challenges, and opportunities highlighted that the biggest pain points for database build are quality and speed. Unsurprisingly, when we are called in to take over activities from other providers as rescue studies, it is typically because the build work was of an inadequate standard. To reflect how seriously we take quality within our group we have embedded a quality gate process across our build milestones. The Quality Gate team reviews every milestone encompassing study start-up through study close to ensure all our endpoints are met from a compliance/eTMF standpoint.

In general, clients are also grappling with data volume –an area that the eClinical elluminate Clinical Data Cloud helps to address for downstream activities. As a data acquisition team, we work extremely hard to streamline the EDC casebook and ensure that data collection is targeted to the critical study endpoints.

Greater trial complexity, with increasing use of adaptive and innovative designs is another prominent area where the right database design is critical. Our team has pioneered some unique approaches for database builds for master protocols and other complex trials that allow for a more flexible architecture and mitigate operational challenges.

How does your team support clients?

Grant Williamson: We support clients with a range of different models – often as part of an end-to-end biometrics’ service for a particular trial or across a full program. In that model, we partner with the data management and biostatistics team and collaborate to deliver a full biometrics package from data acquisition to insight. Our typical clients choose a biometrics-focused outsourcing approach because they want the attention to detail on all clinical data aspects of their trial. They also want the flexibility to select clinical monitoring vendors based on competency without sacrificing data standardization.

Increasingly, we are asked to provide Functional Service Provider (FSP) services for clients who prefer to access support on a functional model. Through our study build FSP service we partner with clients to plan and execute multiple study builds in Medidata RAVE. In this way, we can help our clients build significant efficiencies from build to build while assuring access to qualified data acquisition personnel with the skills to support even the most complex projects.

To learn more about how we could help you improve the quality and speed of your Medidata study builds, book an exploratory conversation.

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