(CSE: AIAI | OTCQB: AINMF | FRA: PF0)
Clinical trials are one of the most expensive, complex, and failure-prone parts of the drug-development ecosystem. Despite decades of medical breakthroughs, the industry still faces staggering inefficiencies: 90% of drugs entering clinical testing never reach the market, and even after a successful Phase 2 study, a company still faces a 50–60% chance of failure in Phase 3.
For investors, those numbers represent both a risk and an opportunity. A single failure can wipe out years of research, hundreds of millions of dollars in capital, and entire biotech pipelines. But a company capable of improving trial success rates—even modestly—could reshape how the pharmaceutical sector allocates time and money.
One Canadian AI company is taking on this challenge head-on.
NetraMark’s Mission: Bring Explainable AI to Clinical Trials
NetraMark Corp. (CSE: AIAI | OTCQB: AINMF | FRA: PF0) is developing a form of explainable AI—called Netra AI—designed to help pharmaceutical companies understand why their trials succeed or fail. Unlike the black-box models dominating headlines, Netra AI is built specifically to interpret small but complex clinical trial datasets, which often include only 100–200 patients.
Why is this important?
Because hidden inside every clinical trial is a mix of:
- Patients who respond very well
- Patients who don’t respond at all
- And subgroups who respond or don’t respond for reasons that aren’t immediately obvious to clinicians
This “heterogeneity problem” is one of the main reasons expensive Phase 2 studies fail. Netra AI aims to solve it.
How Netra AI Works
Netra AI ingests trial data and identifies what the company calls model-derived subpopulations, or “personas. ”
These personas reveal:
- Which specific cluster of patients is actually responding
- Why they’re responding (down to a handful of clinical variables)
- Which patients contribute to trial noise
- And whether a trial should be continued, redesigned, enriched, or stopped entirely
According to NetraMark CEO George Achilleos, the company’s approach isn’t about rescuing failed trials artificially—it’s about uncovering real biological signals that traditional statistics often miss.
For regulators, transparency matters. NetraMark emphasizes that Netra AI is designed to be:
- Fully explainable
- Traceable
- Aligned with FDA Good Machine Learning Practices (GMLP)
- Capable of saying “I don’t know” instead of generating false explanations
This last point is especially important: in healthcare, AI that “hallucinates” or “confabulates” is unacceptable. NetraMark’s system is built to avoid that.
Backed by Real Scientific Validation
In a field filled with hype, NetraMark has taken a more rigorous path: third-party scientific validation.
🔹 NIMH Collaboration
NetraMark partnered with the U.S. National Institute of Mental Health (NIMH) to analyze public clinical trial data involving ketamine in psychiatric conditions.
The AI identified:
- Ketamine responders
- Placebo responders
- Predictors of adverse events
This work has now been accepted for publication in a respected peer-reviewed journal—a rare milestone for an early-stage AI company.
🔹 Clinical Research Organization (CRO) Partnership
In April, NetraMark signed a partnership with Worldwide Clinical Trials, a global CRO operating in more than 65 countries.
They have now completed onboarding and quality assurance audits, and the partnership is entering commercial rollout.
For investors, CRO integrations are meaningful. If Netra AI becomes a tool inside a CRO workflow, it can be deployed across multiple sponsors and therapeutic areas.
Regulatory Milestone Ahead: FDA Critical Path Innovation Meeting
NetraMark is scheduled to meet with the U.S. FDA this December under the Critical Path Innovation Meeting (CPIM) pathway—a rare opportunity reserved for technologies viewed as potentially impactful to drug development.
According to Dr. Luca Pani—NetraMark’s Chief Innovation & Regulatory Officer and former head of Italy’s medicines agency—a best-case scenario could involve exploring a pathway toward Drug Development Tool (DDT) qualification for Netra AI.
At minimum, the meeting exposes Netra AI to the agency’s scientific reviewers, building familiarity, trust and – most importantly asking for guidance and compliance.
In an industry where companies fear introducing new technology too early, NetraMark is taking the opposite approach: engage early, engage often, and be transparent.
Where the Company Stands Today
After three years of team-building, validation, and market testing, NetraMark is now entering what the company describes as its commercialization phase.
What’s next?
- Scaling contracts
- Expanding collaborations
- CRO deployment
- Moving toward EBITDA-positive operations
- Establishing Netra AI as a standard tool in Phase 2/3 trial planning
CEO George Achilleos put it simply:
“Our goal is to help pharmaceutical companies design smarter trials—
to save time, reduce failures, and ultimately help more patients.”
Dr. Pani adds that AI is poised to become as essential to clinical trials as biostatistics—not in five years, but likely within the next year or two.
Watch the Full Interview
To dive deeper into NetraMark’s technology, strategy, regulatory roadmap, and industry impact, you can watch our full interview with George Achilleos and Dr. Luca Pani below:
Final Thoughts
AI is moving quickly—but in highly regulated industries like pharmaceuticals, only companies that can explain their AI will win. NetraMark is not chasing hype; it’s building mathematical, regulator-aligned specialized AI tools aimed directly at the most expensive problems in drug development: clinical trial failure due to poor design and execution.
With scientific validation, regulatory engagement, and commercial rollout underway, the next 12 months could be pivotal for the company.
As always, this is an early-stage story—but a highly compelling one.
Disclaimer
This article is for informational and educational purposes only and should not be considered investment advice.
Readers should conduct their own due diligence and consult with a registered investment advisor before making investment decisions.
MoneyNews.Today was not compensated to publish this article. At the time of this article, the author does not hold shares of NetraMark but reserves the right to buy or sell stock at any time. The author’s company, SmallCap Communications, operates the financial publisher MoneyNews.Today.
