The workspace was designed to accelerate and strengthen decision-making in upstream trial planning

SAN FRANCISCO, CA / ACCESS Newswire / January 28, 2026 / Unlearn, a leader in AI solutions for clinical development, today announced the launch of TrialPioneer, an AI-powered workspace that helps clinical development teams accelerate and strengthen decision-making in upstream trial planning-optimizing study designs to maximize the probability of success with speed and scientific rigor.

Upstream trial planning is where teams make and refine the design choices that shape a study's feasibility and likelihood of success. These choices include specifying endpoints, eligibility criteria, target populations, and key assumptions about outcomes, often under significant uncertainty. As evidence evolves, internal strategy shifts, and cross-functional review cycles progress, planning workflows can become fragmented, with scattered literature searches, disconnected analyses, and one-off simulations that are hard to reproduce or revisit as the design changes.

TrialPioneer addresses this gap with a purpose-built workspace that brings together evidence, assumptions, historical benchmarks, and scenario evaluations in one workflow to optimize study designs. By making assumptions explicit and traceable, and enabling comparisons across design scenarios, TrialPioneer helps study teams evaluate trade-offs earlier and align on the strongest path forward. Unlike workflows where evidence review, analyses, and simulations live in separate systems, TrialPioneer keeps the decision context connected as trial designs evolve.

By grounding assumptions in historical evidence and disease-relevant context, and streamlining evidence review and scenario setup, TrialPioneer helps clinical development teams align earlier and faster on key trade-offs, build confidence in design choices ahead of governance reviews, and reduce late-stage rework when planning decisions are revisited.

How TrialPioneer Works

TrialPioneer integrates three core capabilities into a single workflow:

  • Scout - AI-powered precedent review:

    • Continuously structures and summarizes scientific and regulatory precedent from sources such as PubMed, ClinicalTrials.gov, and FDA databases-so teams can easily reference what's been done in all publicly available trials.

  • Hindsight - Historical benchmark exploration:

    • Enables teams to compare clinical and statistical assumptions against what's been observed in harmonized patient-level clinical trial and real-world datasets-supporting benchmark-driven planning and earlier.

  • SimLab - On demand trial simulations:

    • Allows teams to model and compare trial design scenarios to explore what could happen across endpoints, eligibility criteria, and sample size-producing explainable outputs tied to underlying assumptions and evidence.

"Clinical development leaders are under pressure to move faster while maintaining scientific rigor," said Steve Herne, CEO of Unlearn. "TrialPioneer was designed to help teams pressure test trial design decisions earlier-linking evidence, assumptions, benchmarks, and scenario outputs in one workflow as designs evolve."

"The ability to summarize key features of past trials, construct disease-specific cohorts, and run clinical trial scenarios on demand changes how teams make study design and protocol decisions," said Dr. Robert Lenz, strategic advisor to Unlearn. "Most teams spend weeks going back and forth on questions that TrialPioneer can help answer in real time. Because the work is saved and traceable, you're building institutional knowledge instead of starting from scratch every time."

About Unlearn

Unlearn exists to transform clinical development by making every trial smarter. Partnering with pharmaceutical and biotechnology companies, Unlearn harnesses data, AI, and digital twins to enable faster, more robust studies and clearer decision-making across clinical development. With a science-first approach and deep regulatory engagement-including EMA qualification and FDA support-Unlearn brings unmatched scientific credibility to applying AI in clinical trials.

Industry analysts, pharmaceutical, and biotechnology teams interested in learning more about TrialPioneer can visit URL to request additional information.

Media Contact:
Heather D'Angelo
[email protected]

SOURCE: Unlearn AI



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