Meghna Rajesh, senior research analyst for Beroe Inc., discusses how RTCT will impact supply chains and how sponsors need to consider that now.
For roughly six decades, the basic data model of drug development has barely changed. Sites collect patient data, sponsors clean and analyse it in batches, and regulators see the results in periodic packages, often months after the events they describe.
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Former FDA Commissioner Marty Makary summed up the problem when the agency announced its Real-Time Clinical Trials (RTCT) initiative on 28 April 2026: “For 60 years, we’ve been conducting clinical trials the same way, where key data signals can take years to reach the FDA.”
RTCT is designed to close that gap. Pre-agreed safety signals and endpoints are transmitted from sponsor platforms to FDA reviewers while the trial is running, rather than after a database lock.
Two proof-of-concept studies are already live: AstraZeneca’s TRAVERSE, a Phase II study in treatment-naïve mantle cell lymphoma at MD Anderson and the University of Pennsylvania, and Amgen’s Phase Ib STREAM-SCLC study in limited-stage small cell lung cancer. Paradigm Health, whose platform validated the signals in the AstraZeneca study, says key signals can now be shared “with trial sponsors and the FDA in days, rather than months,” as Clinical Trials Arena reported at launch.
The agency’s longer-term ambition is what it calls continuous trials, in which the pauses between Phases I, II and III would shrink or disappear because regulators already hold the evidence they need for a go/no-go decision.
Most commentary so far has focused on what RTCT means for regulators, biostatisticians and data managers. Far less attention has gone to a group that will feel the change just as sharply: the people who buy and manage everything that keeps a trial running. When decisions speed up, the clinical supply chain must speed up with them, and most of today’s supplier contracts were never written for that.
From batch to stream, and why procurement should care
In a conventional study, data moves in a straight line from site visit to monitor collection, EDC entry, cleaning, database lock and scheduled submission. Each step adds lag, and that lag has quietly shaped how procurement works. Demand forecasts are built from historical enrollment rates and protocol assumptions, then refreshed when IRT reports arrive. Manufacturing slots are booked months in advance for fixed volumes. Supplier performance is reviewed monthly or quarterly. The rhythm of buying mirrors the rhythm of reporting.
RTCT breaks that rhythm. If a regulator sees a clean safety profile at week six of a Phase I study, the sponsor may move into Phase II far sooner than its supply plan assumed. If an adverse signal surfaces at week ten, active manufacturing may need to stop within days. In both cases, the costly mistake is the same: a supply chain still running on last quarter’s forecast while the trial itself has already moved on.
That makes RTCT a procurement question as much as a regulatory one. There are five places where the change will be felt first.
Forecasting must look forward, not back
Clinical supply has always carried a large safety margin because forecasts are uncertain. Sponsors commonly plan for 150% to 200% overage to cover unpredictable enrollment, attrition and country-level variation, according to ZS, and IQVIA puts the median waste of investigational product kits across trials at around 50%. Much of that buffer exists simply because sponsors see real demand late.
Live enrollment and visit-completion data change the equation. When the signals that reach the FDA also reach the supply team, demand can be predicted weeks ahead instead of reconstructed after a shortfall. The practical step is contractual. IRT agreements should require that real-time demand signals are made available through an API to the sponsor’s planning and procurement systems, not only to the clinical team’s dashboard. Without that clause, the data exists, but the people who order supply never see it in time. Even a modest reduction in overage on a large programme frees meaningful budget, which makes this the easiest part of the RTCT business case to make internally.
Real-time data does not remove the need for buffer stock, and it would be a mistake to treat it that way. Manufacturing lead times, release testing and import timelines do not shrink because data moves faster. What changes is where the buffer sits and how quickly it can be redeployed. A sponsor with live visibility can hold safety stock centrally and push it to the sites that need it, rather than spreading it evenly across every depot in case of a surprise.
CDMO contracts need flexibility written in, not negotiated later
Fixed-volume, fixed-schedule manufacturing agreements exist for good reasons. They lock in capacity for sponsors and give CDMOs predictable revenue. Under RTCT, they become a liability.
Phase transitions that once took months may now compress into weeks. So what happens when the trial changes direction, but the contract doesn’t? The sponsor goes back to renegotiate, and the time RTCT saved on the regulatory side is lost on the manufacturing side.
The answer is to design flexibility in at the sourcing stage: scale-up triggers tied to enrollment thresholds, scale-down or pause rights without punitive penalties, and options to pull forward or defer production milestones. The same thinking applies to comparator sourcing and cold-chain logistics, where replenishment can follow actual site consumption rather than a fixed calendar.
Picture a first-in-human oncology study with a single drug product campaign sized for dose escalation. The safety data supports opening an expansion cohort far earlier than planned. If the CDMO agreement holds a reserved slot that can be confirmed on an enrollment trigger, the sponsor simply exercises an option. If it doesn’t, the sponsor joins the queue.
Will CDMOs charge for this flexibility? Of course, and they should. The negotiation shifts from unit price to the cost of optionality, and sponsors that can share reliable real-time demand data will be best placed to bring that cost down.
Participant support has to keep pace with the data
Stipends paid every two weeks. Travel booked days ahead. Reimbursements processed in batches. That is still the norm in most trials.
Once visit status is reported in near real time, why should payments lag behind it? Participants will ask that question, and sponsors should have an answer. Linking stipends and reimbursements to confirmed visit completion is a simple change, and patient-payment and travel vendors should be asked whether they can act on those triggers automatically.
Retention is one of the most fragile parts of any trial. It matters even more when regulators are watching dropout as it happens.
Vendor qualification needs a real-time test
Many trial systems, from eCOA and IRT to patient-payment platforms, were built to export files on a schedule. RTCT favours platforms that exchange data continuously through secure, documented APIs.
The FDA has not yet published detailed technical specifications for real-time reporting. That is a reason to prepare, not to wait. Four questions belong in RFPs now. Does the platform support event-driven data exchange through APIs? What data latency will the vendor commit to in its SLA? How are audit trails and 21 CFR Part 11 controls maintained for streamed data? Can it connect to the sponsor’s RTCT platform without a custom build?
A vendor that cannot answer all four today is not automatically out. But its roadmap should be scored and its commitments written into the contract.
Oversight has to change too. Monthly reviews make little sense for a trial that reports daily. Real-time dashboards and automated alerts, tracked against KPIs such as forecast accuracy, time from demand signal to resupply and data latency, will say far more about readiness than cost per kit ever could.
A new category of spend: the real-time data pipeline
RTCT introduces something procurement has never had to buy before: the pipeline that carries trial data to the regulator. Clinical Trials Arena reports that Paradigm Health’s end-to-end trial platform is being used across the programme through a collaboration with the FDA.
That raises questions that land squarely on procurement’s desk. Who holds the contract, the sponsor or the CRO? Who pays for integration and validation? And who owns the connection to the regulator if the CRO relationship ends partway through a study?
Full-service CROs may offer to manage this layer. That is convenient, but it can make switching providers harder later. Sourcing the technology directly gives more control, along with the integration burden. Neither model suits every sponsor. What matters is making the choice deliberately, rather than inheriting it from whichever vendor happens to run the first RTCT study.
One clause deserves extra attention: data access. Who can see streamed data, in what form and when? And who is accountable if a transmission error reaches the FDA? Most eClinical contracts today are silent on both.
The risks procurement can help contain
Real-time visibility cuts both ways. Writing in Clinical Leader, Kimberly Chew and Odette Hauke warn that unverified data errors could reach regulators as apparent safety signals, and that sensitive data flowing through third-party platforms raises confidentiality and intellectual property concerns. Both are, at least in part, contracting problems, and both belong in vendor agreements from day one.
Then there is access. Continuous reporting takes infrastructure that large sponsors can fund far more easily than small biotechs. As Parexel CEO Peyton Howell put it at launch, “access for biotech sponsors will be critical”. For smaller companies, the choice of CRO and technology partner may decide whether real-time trials are open to them at all.
Procurement needs a seat closer to the trial
A flexible CDMO clause is worth little if no one can exercise it quickly. Who can trigger a scale-up or a pause? On what evidence, and within what budget? These decision rights need to be agreed before the first signal arrives, not after.
In practice, that means category managers seeing the same operational dashboards as study teams, and joint governance between procurement, clinical supply and clinical operations. It also means budgeting differently. Flexible capacity and integration carry upfront costs, and procurement will need to show finance the savings on the other side, from lower waste to shorter gaps between phases.
What to do now: RTCT is part of a wider push to modernise US clinical development, including HHS’s Operation TrialBlazer, launched in June 2026. The direction is clear, even if the pace of the formal pilot is not. Procurement leaders can start with three steps.
First, identify the studies most likely to run under real-time reporting, typically early-phase oncology and other programs where a fast go/no-go decision matters most.
Second, build flexible capacity terms, real-time data clauses and clear data access rights into the next round of CDMO, IRT, CRO and patient-support contracts.
Third, add real-time readiness to vendor qualification, so the supplier base is ready before the first study is.
RTCT changes more than the regulatory timeline. It changes what procurement is for: no longer planning around a fixed forecast, but running a supply chain that moves with the trial. The teams that start adapting now will be the ones whose trials can move as fast as the evidence allows.
