Ensuring Global Compliance With:
Core Capabilities of Octalsoft AI/ML
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.
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.
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.
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.
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.
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.
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.
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
