The Performance-Based CRO since 2014
Validcare is the Performance-Based CRO. Accountable contracting, fixed-price delivery, and a results focus — built for sponsors, sites, and participants who measure clinical research by what gets done, not by what gets billed.
FDA’s April 2026 Real-Time Clinical Trials announcement
In April 2026, FDA announced the Real-Time Clinical Trials (RTCT) initiative — a public articulation that the six-decade-old data-flow architecture of clinical trials is ready to change. FDA’s announcement named two proofs-of-concept: the AstraZeneca TRAVERSE Phase 2 trial in mantle cell lymphoma, conducted with technical partner Paradigm Health, and the Amgen STREAM-SCLC Phase 1b trial in small cell lung carcinoma. A pilot program will select final participants in August 2026, with an RFI on AI-enabled trial tools (docket FDA-2026-N-4390) collecting comments through May 29, 2026.
FDA’s April 2026 announcement noted: “FDA scientists view safety signals and endpoints in real time as the trial progresses.” That is what the RTCT pattern provides for regulators — not a static submission delivered a year after the data were generated, but a live view of the safety and efficacy signals at the cadence the trial calls for.
Validcare’s RTCT definition
Validcare’s working definition of Real-Time Clinical Trials: each stakeholder — Sponsor, Site, Participant, IRB, Regulator — has access to the clinical information that is relevant and important to their role, when they need it, on the cadence the study protocol and study plan require.
This definition is honest about cadence differences. IRB review happens on a schedule the protocol defines. Regulatory access happens when reporting requirements call for it. Sponsor and site visibility into the moment-by-moment trial operation happens continuously. All are anchored to the protocol — a regulated artifact — rather than to a generic data-flow buzzword.
Validcare delivers this on the SmartSource™ Clinical Trial Platform.
The legacy pattern this replaces
For six decades, clinical trial data has flowed through best-effort integration of siloed legacy systems. Sponsors waited for data freezes. Sites repeated the same fields across multiple systems. Regulators inherited the lag — receiving submissions a year after the data were generated, then beginning their review.
The economic consequence is the size of the SDV (Source Data Verification) budget in a traditional trial: the apparatus of reconciling captured data back to its source, after the fact, is what makes site-based and remote SDV expensive.
The result: Data Quality Outcomes
When the platform supports Source Data Collection at the point of care — data entering the system when and where the protocol-defined activity generates it — the result chain compounds:
- Cleaner data at database lock, because cleaning is continuous, not a lockdown rush at the end.
- Reduced expenses associated with site-based and remote Source Data Verification, because the source IS the data. The SDV scope traditional CROs price against collapses.
- Less rework and fewer queries downstream, because issues are caught in the moment instead of compounding into protocol deviations.
The horizon: Continuous-Trial-Ready
FDA’s own framing points beyond RTCT to a continuous-trial future — trials that run across phases without the artificial seams between Phase 1, Phase 2, and Phase 3 cohorts. Validcare’s platform and operations are positioned for that horizon today.
Validcare is operationally aligned with the architecture FDA is piloting industry-wide. The Performance-Based CRO that has been delivering this for a decade now has a name for the category. Real-Time Clinical Trials. Today.