NetraMark Founder Coauthors New Publication on AI/ML Use in Clinical Trials, Alongside Authors From Leading Global Regulatory Organizations

Rhea-AI Summary

NetraMark Holdings announced that its founder Dr. Joseph Geraci led the authorship of a significant publication in the Journal of the Society for Clinical Data Management about AI/ML integration in clinical trials. The paper, co-authored with experts from FDA, EMA, DKMA, and major pharmaceutical companies, explores seven real-world use cases for AI in clinical trials, including smart data query, patient stratification, and external control arms. The publication addresses key challenges like AI model generalizability and ethical considerations such as privacy controls. The paper aligns with NetraMark's NetraAI platform capabilities, which focuses on small dataset modeling, explainability, and patient enrichment strategies for clinical trials.

TORONTO, June 12, 2025 (GLOBE NEWSWIRE) -- NetraMark Holdings Inc. (the “Company” or “NetraMark”) (CSE: AIAI) (OTCQB: AINMF) (Frankfurt: PF0), an artificial intelligence (AI) solutions company transforming clinical trial design in the pharmaceutical industry through streamlined access to actionable analytics uncovered by AI, today announced that NetraMark founder Dr. Joseph Geraci was the lead author on a new publication that outlines the market opportunity for AI/ML to improve data quality and patient outcomes in clinical development.

This manuscript, now available in the Journal of the Society for Clinical Data Management (JSCDM), is titled “Current Opportunities for the Integration and Use of AI/ML in Clinical Trials: Good Clinical Practice Perspectives.” It identifies the ideal conditions and prerequisites for the use of emerging AI applications in clinical trials and the importance of aligning these technologies with Good Clinical Practice (GCP).

Dr. Joseph Geraci, Founder, CSO, and CTO of NetraMark, contributed to this collaborative effort alongside individuals affiliated with organizations such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Danish Medicines Agency (DKMA), Pfizer, Sanofi, Neurocrine Biosciences, Saama Technologies, Relation Therapeutics, Cognizant Technology Solutions, and Wega Informatik AG. These contributions represent the personal views of the authors and not the official positions of their respective organizations.

Drawing on the collective insights of regulators, sponsors, and technology developers, this publication explores the multifaceted landscape of AI/ML applications, where AI can deliver measurable benefits while ensuring compliance, transparency, patient safety, efficiency, accuracy, and overall effectiveness of clinical trials, specifically through seven real-world use cases:

1. Smart Data Query
2. Data Attributability Challenges in Wearable Device Data
3. Enhancing Protocol Deviation Trending
4. External Control Arms
5. Streamlining Complaint Handling
6. Patient Stratification in Diagnosis
7. Patient Enrichment for Placebo/Drug Response
   

Additionally, the manuscript highlights several challenges and ethical considerations facing AI/ML adoption in clinical trial, including:

Challenges

• Generalizability - how well AI models can perform beyond their original training, testing, and validation data
• Provenance - the decisions, implicit or hidden, that were made in the creation of a model
• Effective clinical trialist-AI/ML interaction
  

Ethical Considerations

• Robust, multi-layered privacy controls
• Trustworthy AI that is lawful, ethical, and technically and socially robust

Built for Compliance, Designed for Impact: How NetraAI’s Capabilities Align with Industry Needs

Built from the ground up to advance the impact that AI can have on clinical trial enrichment, NetraAI goes beyond traditional AI assessments to provide a specialized solution for small or sparse dataset modeling, addressing the key conclusions of the JSCDM manuscript:

• Explainability and Auditability
• Data Quality Monitoring and Anomaly Detection
• Patient Stratification and Enrichment
• Mitigation of Placebo Response
• Multi-modal Data Integration
• Explainability and Auditability
• Ethical and Regulatory Alignment

“It was an honor to contribute to this significant review alongside respected voices from across the global regulatory and pharmaceutical landscape,” said Dr. Joseph Geraci, Founder, CSO, and CTO of NetraMark. “NetraMark is committed to working with sponsors to realize the benefits of AI/ML adoption in traditional clinical trial processes. Our collective work underscores the opportunities for NetraAI to help set the standards in the pharmaceutical industry and establish the best use of AI/ML and ethical compliance for clinical trial evolution.”

This review is available to the public at https://www.jscdm.org/article/id/426/.

About NetraMark
NetraMark is a company focused on being a leader in the development of Generative Artificial Intelligence (Gen AI)/Machine Learning (ML) solutions targeted at the Pharmaceutical industry. Its product offering uses a novel topology-based algorithm that has the ability to parse patient data sets into subsets of people that are strongly related according to several variables simultaneously. This allows NetraMark to use a variety of ML methods, depending on the character and size of the data, to transform the data into powerfully intelligent data that activates traditional AI/ML methods. The result is that NetraMark can work with much smaller datasets and accurately segment diseases into different types, as well as accurately classify patients for sensitivity to drugs and/or efficacy of treatment.

Forward-Looking Statements
This press release contains "forward-looking information" within the meaning of applicable Canadian securities legislation including statements regarding the potential use of NetraMark’s AI solutions to drive intelligent, patient-centric clinical trial optimization, the optimization of clinical trials by uncovering hidden patient subpopulations, how NetraAI may address the key conclusions of the JSCDM manuscript, the integration of NetraMark’s AI as a dedicated solution to advance clinical trial success, NetraMark's commitment to working with sponsors to realize the benefits of AI/ML adoption in traditional clinical trial processes, opportunities for NetraAI to help set standards in the pharmaceutical industry, the establishment of best practices for AI/ML use and ethical compliance, and the advancement of technological capabilities of clinical trial enrichment, which are based upon NetraMark’s current internal expectations, estimates, projections, assumptions and beliefs, and views of future events. Forward-looking information can be identified by the use of forward-looking terminology such as “expect”, “likely”, “may”, “will”, “should”, “intend”, “anticipate”, “potential”, “proposed”, “estimate” and other similar words, including negative and grammatical variations thereof, or statements that certain events or conditions “may”, “would” or “will” happen, or by discussions of strategy. Forward-looking information includes estimates, plans, expectations, opinions, forecasts, projections, targets, guidance, or other statements that are not statements of fact. The forward-looking statements are expectations only and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results of the Company or industry results to differ materially from future results, performance or achievements. Any forward-looking information speaks only as of the date on which it is made, and, except as required by law, NetraMark does not undertake any obligation to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise. New factors emerge from time to time, and it is not possible for NetraMark to predict all such factors.

When considering these forward-looking statements, readers should keep in mind the risk factors and other cautionary statements as set out in the materials we file with applicable Canadian securities regulatory authorities on SEDAR+ at www.sedarplus.ca including our Management’s Discussion and Analysis for the year ended September 30, 2024. These risk factors and other factors could cause actual events or results to differ materially from those described in any forward-looking information.

The CSE does not accept responsibility for the adequacy or accuracy of this release.

Contact Information:
Swapan Kakumanu - CFO | swapan@netramark.com | 403-681-2549

FAQ

What is the significance of NetraMark's publication on AI in clinical trials?

The publication, led by NetraMark's founder, outlines opportunities for AI/ML in clinical trials and includes contributions from major regulatory bodies like FDA and EMA, establishing best practices for AI integration in clinical development.

What are the main use cases for AI in clinical trials according to NetraMark's publication?

The publication identifies seven key use cases: smart data query, data attributability for wearables, protocol deviation trending, external control arms, complaint handling, patient stratification, and patient enrichment for placebo/drug response.

What challenges does the NetraMark publication identify for AI adoption in clinical trials?

The main challenges include AI model generalizability beyond training data, model provenance decisions, and effective clinical trialist-AI/ML interaction.

How does NetraMark's NetraAI platform address the challenges mentioned in the publication?

NetraAI specializes in small dataset modeling and offers capabilities including explainability, auditability, data quality monitoring, patient stratification, and multi-modal data integration while maintaining ethical and regulatory alignment.

Where can investors find the complete NetraMark AI clinical trials publication?

The publication is publicly available at https://www.jscdm.org/article/id/426/.