–by Tobi Guennel, PhD, CTO & Co-Founder, QuartzBio
The starting gun: calling an end to batch-reporting
The FDA has unveiled two proof-of-concept real-time clinical trials (RTCTs) already underway with AstraZeneca and Amgen, alongside a Request for Information for a broader pilot program. The message from the FDA is blunt: sixty years of batch-reporting clinical data to the FDA is over. The agency wants to see safety signals and endpoints as they happen.
This shift toward continuous insight may certainly help get therapies to patients faster, an exciting prospect.
But that shift also represents an extraordinary operational demand, and most biopharma teams are not yet equipped to meet it.
The old model can’t keep up
The traditional clinical trial model is built around a relay race: sites collect data, sponsors aggregate it, and the FDA receives it months or years later. RTCTs, in theory, collapse that timeline to near-zero.
We say “in theory” because the underlying data infrastructure has been, and remains, the bottleneck.
Clinical sample collection logs scattered across labs and EDC systems. Biomarker results siloed by assay type or vendor. Shipment tracking in a spreadsheet. Query resolution handled over email. These fragmented workflows are fundamentally incompatible with real-time reporting.
Continuous trials raise the stakes further
For continuous trials — the FDA’s stated ultimate goal — the stakes are even higher than for RTCTs. When there is no pause between trial phases, there is no grace period to reconcile data, resolve discrepancies, or retrospectively reconstruct sample provenance. Every gap in your sample-to-result data chain becomes a gap in your regulatory submission.
The FDA’s Chief AI Officer noted that real-time trials could eliminate the costly hiatus between development phases entirely. That only works if data infrastructure is interoperable by design and if data quality is continuously maintained instead of periodically patched.
How to close the infrastructure gap
At QuartzBio, we built the first platform to close this infrastructure gap by connecting sample, clinical, and biomarker data across the R&D lifecycle.
By integrating data from various sources and systems across the entire lifecycle of a sample, the QuartzBio Platform creates a continuously validated, trusted data foundation for samples, the ultimate source of biologically derived insights.
This empowers teams to proactively monitor sample-related KPIs that, in real time, help ensure validity of the scientific insights being derived in a trial.
Samples are monitored from collection through processing, testing, and storage — with automated compliance monitoring, real-time discrepancy detection, and shipment tracking integrated directly with courier networks. If a sample is missed, collected out of protocol, or approaching stability expiration, it’s flagged immediately. Once samples are tested, our platform automatically ingests and harmonizes results across EDCs, central labs, and specialty labs into a unified, analysis-ready ecosystem. Rather than waiting for a data lock to begin QC, teams can run automated integrity checks and visualize biomarker signals as data arrives, improving trial execution on study.
That is the kind of continuous operational awareness RTCTs require.
Why agentic AI is the missing piece
Agency, or the ability of a system to ACT instead of just REPORT, is the defining capability of RTCT infrastructure. After all, if a system merely “reports,” waiting for humans to execute, we’re unlikely to see more than incremental acceleration of trials.
Continuous trials require software that autonomously and proactively monitors incoming data streams, identifies issues, initiates queries, tracks resolution, and surfaces emerging signals without waiting for a human to run a report.
Static dashboards are monitoring tools. AI agents are operational partners. QuartzBio’s proactive and prescriptive AI agents partner with subject matter experts, autonomously working across the sample and biomarker data ecosystem. Not only can these agents enable continuous feedback loops for better decision-making, but they also free human teams to spend their time on interpretation and innovation instead of data-wrangling.
The window is now
The FDA has demonstrated that real-time trials are technically feasible. In July, the FDA will release its pilot program selection criteria, and every clinical-stage biopharma team is under pressure to determine how their operational infrastructure can keep pace.
By redefining the way samples and their associated data are managed at scale, turning fragmented processes into a trustworthy data foundation, QuartzBio is setting up clinical organizations for success.
Connect with the QuartzBio team to assess your readiness for real-time and continuous trials, and to see how QuartzBio’s agentic framework provides the infrastructure R&D teams need.
