Know when to act months earlier.
Bring forward decision-making to the exact moment an answer emerges in the unblinded comparative data.
Traditional interim analysis delays critical decisions
Clinical trials generate data faster than ever, but the way that data is evaluated has changed little since the 1990s. Interim analyses are among the highest-impact tools in clinical development, yet each look can require unblinding, manual coordination and a statistical penalty.
As a result, sponsors rely on a small number of predetermined snapshots rather than evaluating evidence as it emerges. Critical evidence can go unseen for months before it informs a decision.
63%
of industry trials report no planned interim look on CT.gov
50+
successful trials likely stopped in error every year by futility analyses
$15bn+
costs each year running trials past the point of statistical clarity
Same trial. Same data. A different moment.
See what changes when evidence is evaluated continuously instead of at predetermined intervals. Each scenario shows when prespecified criteria are met and what reaching that moment earlier can mean.
Earlier evidence. Better decisions.
Continuous automated analysis of unblinded data does not replace expert decision-making. It gives clinical teams valid evidence earlier, creating more opportunities to improve the course of a trial, protect patient safety or reallocate resources. What a sponsor receives is not an alert but a documented decision package, and it moves through the organization on a defined path.
Evidence released
A pre-specified threshold is crossed and an evidence package leaves Pre.sentient's enclave.
Independent statistician and DMC
The only parties permitted to see unblinded data. Using the same data cut as Pre.sentient, the unblinded statistician can corroborate the analysis from the released package rather than taking it on trust.
DMC issues a recommendation
The recommendation — continue, continue with modification, or stop — is released to the recipient named in the charter; the unblinded data itself never crosses that boundary. In line with a prespecified updated DMC charter, estimated probability of success can be released to named recipient for firewalled non-trial function such as commercial/regulatory preparations.
Sponsor decides
Safety assessment, protocol amendment, increase recruitment for the re-estimated sample size, exclusion of an underperforming subgroup from future analyses, futility stop, or activation of a firewalled non-trial function, such as regulatory or manufacturing preparations.
Execution
Sites, supply, manufacturing, regulatory planning and portfolio allocation respond to the decision, within the information barrier the charter defines.
Notification and record
Investigators, IRB/EC and regulators as the decision requires, including investigation of any DMC safety recommendation as potentially reportable under §312.32. Minutes, the additional principled analyses explored during the DMC meeting, determination and dates retained for audit/inspection.
New methodology.Established standards of rigor.
Where Pre.sentient introduces new methods, we publish the principles, operating characteristics and error rates so statisticians can independently evaluate performance. Other methods are grounded in established literature and regulatory guidance.
Bringing new methodology to regulators early.
Pre.sentient has engaged with regulators through established pathways for evaluating new statistical approaches, including the FDA and EMA.
FDA, June 2026. Following our Letter of Intent to the ISTAND qualification program (DDT-IST-000076) which detailed the Pre.sentient approach for early stopping for futility and early detection of success without stopping, FDA confirmed that Pre.sentient addresses a process within the purview of the sponsor and the Data Monitoring Committee rather than one requiring qualification as a drug development tool, and directed sponsors to engage on trial-specific use through individual IND submissions.
EMA, October 2025. We presented Pre.sentient's platform to the EMA Innovation Task Force, with experts from PEI, CBG-MEB, ANSM and AGES-BASG. Experts saw benefits in principle and had no concerns for automated futility assessment. For stopping early for likely success the experts noted that frequent interim testing for efficacy raises type I error considerations, and directed us to the SAWP secretariat on Qualification of Novel Methodologies.
Read the FDA announcementFrequentist framework, reproducible execution.
Pre.sentient's continuous analysis extends frequentist methods rather than replacing them. Decision thresholds are fixed before the trial begins and characterized by simulation. The algorithm is deterministic: the same data produce the same result every time.
- Futility monitoring is non-binding and leaves the type I error rate of the final analysis unchanged. The success signal is not a stopping rule, triggers no efficacy claim and spends no alpha
- Thresholds calibrated using 100,000 simulated trials
- Statisticians can benchmark the algorithm against scenarios of their own choosing
Engineered so evidence remains trustworthy.
Clinical decisions depend on confidence in both the methodology and the infrastructure. The platform is designed to protect data, preserve independence, and support regulated environments. ~40% of Pre.sentient employees come from a cybersecurity background, which reflects how we prioritize the security of the enclave architecture.
- Dedicated secure hardware enclaves with end-to-end encryption
- ISO/IEC 27001 and ISO 9001 certified
- Designed to support FDA 21 CFR Part 11, EU Annex 11, HIPAA, GDPR, and GxP requirements
Built by leaders in medicine, statistics, and clinical development.
Pre.sentient's leadership spans clinical medicine, applied mathematics, AI, and pharmaceutical development. Pre.sentient was founded by Tom Coates, a physician and former CMO, and Dan Nicolau, a physician and mathematician who leads the statistical work. Advisors include the former Director of Biostatistics at FDA CDER, other regulatory experts who have worked on thousands of trials as well as pioneers in clinical trials data management and statistical software.
- Advisors include pioneers in electronic data capture, clinical trial innovation, and former FDA biostatistics leadership
- Our mission is to transform trials everywhere with realtime analysis
See what it could mean for your next study
For decades, earlier insight meant more operational complexity and more risk to the trial integrity. It no longer does. Talk with us about where continuous analysis fits across your development portfolio.