Netramark Holdings, Pentara form partnership

Executive Summary

• Netramark Holdings Inc. has entered into an agreement with Pentara Corp. to co-brand and launch a novel site intelligence tool designed to enhance clinical trial integrity.
• The partnership leverages Netramark’s AI technology to detect anomalous site and participant behavior, aiming to safeguard the validity of study conclusions and mitigate early risks in clinical trials.
• The initiative focuses on using advanced AI-driven anomaly detection to provide data-driven insights for sponsors, improving trial design and site selection processes.

Key Details

• Parties Involved: Netramark Holdings Inc. and Pentara Corp.
• Agreement Type: Partnership agreement for co-branding and launching a joint initiative.
• Product/Technology: A novel site intelligence tool utilizing advanced AI-driven anomaly detection.
• Technical Methodology:
  • Integrates information-theoretic variability, singleton occurrence frequencies, and co-association penalties.
  • Derives a "Paradox Risk score" for anomaly detection at the participant level.
  • Identifies site-level integrity and anomalous risks using only prerandomization data.
• Strategic Goals:
  • Enhance clinical trial integrity by detecting anomalous participants and assessing site-level irregularities.
  • Prevent undetected data integrity issues from distorting efficacy signals.
  • Enable Pentara to proactively mitigate early risks and implement scalable monitoring with real-time alerts and targeted audits.
  • Optimize future trial design by generating validated and explainable insights.
• CEO Quote (Pentara): Suzanne Hendrix, PhD, CEO of Pentara, stated the partnership demonstrates a commitment to providing high-quality, efficient solutions that accelerate medical research through responsible AI use.
• CTO/CSO Quote (Netramark): Dr. Joseph Geraci, Founder, CTO/CSO at Netramark, noted the partnership expands opportunities to leverage AI technology to inform sponsors on trial design improvements beyond participant eligibility, including pretrial site selections and active trial site reporting.

Notable Quotes

• "We are excited to partner with Netramark, which focuses on the responsible use of AI in clinical trials, and the implementation of regulatory-aligned AI strategies that provide data-driven insights to guide success throughout a trial. Applying this innovative technology demonstrates our commitment to providing high-quality, efficient solutions to our clients that accelerate medical research," commented Suzanne Hendrix, PhD, chief executive officer at Pentara.
• "This partnership marks a significant milestone for Netramark as we expand opportunities to leverage our AI technology to inform sponsors of potential areas of improvement in their trial design, beyond participant eligibility criteria and into earlier stages of development, such as pretrial site selections and active trial site reporting," shared Dr. Joseph Geraci, PhD, founder, CTO/CSO at Netramark.