Following the FDA’s announcement of its new Real-Time Clinical Trials (RTCT) initiative, an active Request for Information period has shown that the industry is eager to transform the future of clinical trial execution and regulatory review.

As the technology collaborator supporting the initiative’s current proof-of-concept phase, Paradigm Health has worked alongside the FDA since the earliest stages of the effort to help operationalize a new model for how key clinical trial signals can be identified, analyzed, and shared in near real time. Amgen and AstraZeneca are the first sponsors participating in the initiative, with active studies serving as the initial proof-of-concept programs.

The FDA’s Industry Day on the program provided additional insight into what we are trying to learn through the initiative, and Paradigm Health’s intimate work operationalizing the proof-of-concept phase translates to the best understanding of what sponsors and providers should be thinking about as they evaluate participation.

What Sponsors Should Be Thinking About

Paradigm Health has been working alongside the FDA and sponsors since the earliest stages of the RTCT initiative to operationalize the current proof-of-concept studies. Moving from concept to execution has provided a unique view into what it actually takes to support more continuous, signal-driven clinical trial workflows in practice. Because Paradigm Health is already a foundational contributor to the initiative, we are helping organizations assess candidate studies, evaluate implementation readiness, and identify where eSource-enabled workflows can create the greatest operational impact.

We’ve advised numerous sponsors to evaluate candidate studies and implementation pathways, and several considerations have consistently emerged:

• The strongest candidates are studies already in startup, activation, or early recruitment
• Site readiness and operational workflows matter just as much as technology infrastructure
• Source-connected data collection creates a stronger foundation for timely, traceable signal reporting
• Early alignment between sponsors, sites, and implementation partners reduces downstream operational complexity

Participation will depend on more than selecting the right technology. Study selection, site readiness, and implementation planning are just as important as the underlying infrastructure itself.

What Research Sites Should Be Thinking About

Paradigm Health has seen firsthand what enables providers to participate successfully in more connected, signal-driven research models. 

For provider organizations evaluating participation, several considerations stand out:

• Supporting source-connected workflows without increasing operational burden is becoming an important site differentiator
• eSource readiness can make it easier to participate in studies that require faster, more traceable data collection
• Existing sponsor relationships may create opportunities to expand eSource adoption across additional studies
• Operational scalability and research-ready infrastructure can help differentiate sites as new trial models emerge

As sponsors identify candidate studies and evaluate implementation partners, sites that can demonstrate eSource readiness, operational scalability, and connected research workflows will be better positioned for future study opportunities. For organizations that have not yet implemented eSource, now is the time to establish the infrastructure, workflows, and partnerships needed to participate in future models of clinical research.

Final Thoughts

The next phase of the initiative will give sponsors, providers, and other stakeholders an opportunity to help shape what comes next. Organizations that begin evaluating candidate studies, implementation readiness, and source-connected operating models today may be better positioned as the initiative continues to evolve.

As organizations navigate those decisions, Paradigm Health is already working with sponsors and providers to evaluate candidate studies, assess implementation readiness, and support participation in future phases of the initiative.

If your organization is evaluating eSource adoption, identifying candidate studies for future RTCT participation, or exploring more connected clinical trial workflows, contact the Paradigm Health team to discuss how these models could apply across your research portfolio.