Core Capabilities of Octalsoft AI/ML

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AI-Powered Patient Matching

  • Accelerate patient recruitment by identifying eligible participants from structured and unstructured clinical data.
  • Reduce enrollment timelines with predictive analytics for patient suitability.
  • Enhance trial diversity and representation through smarter matching algorithms.
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AI-Driven DB Build Automation

  • AI algorithms analyze protocol elements to auto-generate study databases and CRFs.
  • Reduce build time by identifying reusable components and optimizing form structures.
  • Ensure consistency across multi-study setups while maintaining validation traceability.
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Automated SDTM Mapping & Conversion

  • ML models automatically detect variable relationships and suggest SDTM domains.
  • Reduce manual programming time while improving accuracy and CDISC compliance.
  • Accelerate submission readiness with continuous validation and mapping traceability.
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Adaptive Randomization & Trial Optimization

  • Adaptive randomization to balance treatment arms efficiently.
  • Protocol design optimization leveraging historical study data.
  • Predictive analytics for enrollment trends, dropout risks, and protocol deviations.
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Predictive Safety & Pharmacovigilance

  • Scan safety databases using ML to detect unexpected patterns in adverse events.
  • Predict adverse event trends earlier than traditional statistical methods.
  • Monitor patient vitals, lab results, and real-time wearable data for proactive intervention.
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AI-Based Medical Coding & NLP

  • AI-powered MedDRA and WHO Drug coding for faster, accurate adverse event reporting.
  • NLP to analyze unstructured clinical notes and coding dictionaries automatically.
  • Reduce manual effort while improving data quality and consistency.
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Automated Document QC & Compliance

  • AI-driven review of eTMF, SOPs, protocols, and CSRs.
  • Automated document redaction to protect sensitive subject information (GDPR, HIPAA).
  • Versioning control and compliance monitoring through predictive ML checks.
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Intelligent Data Quality & Transformation

  • ML-powered edit checks to identify outliers, missing data, and discrepancies.
  • Automated data cleaning, standardization, and transformation for higher quality datasets.
  • Continuous data monitoring for improved audit readiness and operational efficiency.

Resources That Speak
for Octalsoft AI/ML

AI-ML Driven eClinical Suite

AI-ML Driven eClinical Suite

Factsheet – eClinical Analytics

Factsheet – eClinical Analytics

Key Benefits for Every Role
in Your Clinical Trial

Sponsors

Make smarter decisions with predictive insights, adaptive trial designs, and AI-powered oversight that improves trial efficiency and accelerates time-to-market.

CROs

Manage multiple trials consistently, automate safety coding and reporting, and optimize trial design with AI/ML algorithms to scale operations across regions and protocols.

Site Teams

Reduce administrative burden with intelligent patient matching, document QC, and automated reporting, freeing up time to focus on patient care.