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Athaca's purpose-built AI solutions.

Built for maximum safety, auditability, and performance in regulated environments. Every solution includes human-in-the-loop validation, full audit trails, and zero-retention data handling.

Synthetic Patient Generation

Generate clinically realistic patient cohorts, even when real-world data is scarce.


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In rare diseases, early-phase programs, and underrepresented populations, the fundamental challenge is not analytics, it is data. Cohorts are too small, longitudinal records are incomplete, and the patients you need to study may not exist in any available dataset. Teams are forced to make critical development decisions with incomplete evidence or wait months for data to accumulate. Neither option is acceptable when your program timeline is on the line.
 
Our approach is different. Built on a world model architecture, we generate high-fidelity synthetic patient profiles without requiring massive training datasets. While most methods need substantial real-world data to "learn," ours can generate clinically coherent patient trajectories from minimal input, preserving the statistical structure, clinical relationships, and temporal patterns that matter for downstream analysis.

Validation:

We have demonstrated this capability by generating synthetic cohorts for amyloidosis, a rare condition with extremely limited real-world data. The resulting cohorts maintained clinically realistic lab value distributions, comorbidity profiles, and disease progression patterns, validated through comprehensive fidelity auditing against reference literature.

What we deliver:

  • Custom Synthetic Cohorts: Profiles aligned to your specific protocol criteria, complete with realistic lab values, comorbidities, and treatment histories, even for indications where training data is unavailable.
  • Longitudinal Disease Modeling: Simulations of disease progression and treatment response over time, enabling protocol stress-testing and scenario analysis.
  • Comprehensive Fidelity Audits: A transparency report for every cohort quantifying distributional alignment with available reference data and flagging any inherited biases.
  • Privacy-First Architecture: Fully compliant, HIPAA/GDPR-ready datasets with zero re-identification risk, enabling friction-free data sharing.

Where it creates value today:

  • Trial Design Optimization: Stress-test your protocol against synthetic populations before opening enrollment.
  • Power & Sample Size Exploration: Estimate statistical power when historical data is insufficient for traditional methods.
  • Internal Decision Support: Augment underpowered analyses to support go/no-go decisions earlier in development.

Regulatory Context:

Synthetic data is a rapidly evolving frontier. While FDA and EMA frameworks are maturing, we position our current offering for internal decision support, trial design, and exploratory analysis. As regulatory acceptance grows, organizations already validating synthetic evidence will be positioned to move first.

Why it matters:

You make better decisions with the data you have today. You unlock analytical capabilities in rare disease and small populations that are simply not possible with real-world data alone, avoiding expensive mistakes before they happen.

We have generated synthetic patient cohorts for amyloidosis using zero-shot learning. See what Our synthetic patient offering can do for your indication.

Clinical Data Review

Catch what edit checks miss. Lock your database faster.


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Traditional clinical data management relies on predefined edit checks that only catch what they were programmed to find. Meanwhile, data managers spend thousands of hours writing manual queries, reconciling safety and clinical databases, and chasing sites for corrections. The result: delayed database locks and spiraling costs.
 
We deploy reasoning-capable AI agents that analyze your clinical data holistically. They do not just run rules; they understand clinical context. They cross-reference across forms, detect medical inconsistencies, and draft site queries in plain language, ready for your team to review and send.
 
Your data never leaves your control.
Our offering operates on a zero-retention architecture. We process your data within a secure, isolated environment and retain nothing after delivery. Every engagement begins with a data handling agreement tailored to your security requirements.

What we deliver:

  • Holistic Anomaly Detection: Analysis across SDTM/ADaM datasets to surface errors standard edit checks miss.
  • Automated Medical Coding: Semantic analysis for adverse events (MedDRA) and concomitant medications (WHODrug) that understands clinical context.
  • Cross-Database Reconciliation: Automatic flagging of mismatched dates, severity scores, and causality assessments between your safety database and EDC.
  • Pre-Drafted Queries: Query text generated for every discrepancy, saving your data managers hours of manual writing.

Why it matters:

You find more errors, fix them faster, and lock your database weeks earlier. Your data management team is freed to focus on judgment calls, not data entry.

Send us a sample of anonymized data. We will find errors your current edit checks missed.

Protocol Intelligence

Spot design risks before they become enrollment problems.


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Protocol complexity is one of the largest silent drivers of trial failure. Overly restrictive eligibility criteria inflate screen failure rates. Excessive visit schedules burden sites and patients. And most design decisions are still made based on internal precedent rather than systematic evidence. By the time enrollment problems surface, your timeline and budget have already absorbed the damage.
 
We apply AI to the largest body of publicly available trial design data, including registry records, published outcomes, and therapeutic area benchmarks to give your clinical development team an evidence-based assessment of your protocol's design risks.

What we deliver:

  • Complexity Scoring: Identifies restrictive or unusual eligibility requirements and benchmarks them against comparable trials in your therapeutic area.
  • Burden Analysis: Compares your visit schedule and assessment burden against similar protocols to flag opportunities for reduction.
  • Screen Failure Risk Detection: Literature-backed identification of criteria historically associated with high failure rates in your specific indication.
  • Actionable Intelligence: A clear report with specific recommendations your team can evaluate before finalizing the design.

What we do not do (yet):

We are transparent about scope. Our initial release focuses on design benchmarking and complexity analysis using public data. We do not offer predictive enrolment forecasting or site-level performance modeling; these are on our roadmap and will require validated proprietary benchmarks before we offer them.

Why it matters:

You catch design issues in weeks instead of discovering them six months into enrolment. Simpler protocols recruit faster, retain more patients, and reduce the risk of costly mid-study amendments.

Share a draft protocol. We will deliver a protocol intelligence report with specific design recommendations.

Build Clinical-Grade AI for the Real World

Athaca partners with life sciences and healthcare organizations to design, validate, and deploy AI systems grounded in clinical reality and scientific rigor.