SageMed Bridge
AI-native platform for clinical evidence management and integration
Platform capabilities
Literature Review
▫ Systematic Literature Review (SLR) · Gap Analysis · Scoping Review · Competitive Landscape
▫ Literature search and pdf retrieval from public databases
▫ SLR protocol generation, L1/L2 screening, data extraction, and data management
▫ Meta-analysis, TFL outputs, article appraisal, evidence synthesis and reporting,
▫ All integrated with human verification with full audit trails.
▫ Structured numeric data tables ready for analysis
Real World Data
▫ Integrated EDC (LibreClinica) or connect to your EDC (Medrio, Castor, Medidata) via API
▫ Automated daily dashboards for DM monitoring: enrollment, queries, AEs, visit compliance, protocol deviations
▫ Sample size calculation
▫ Document generation: protocol, SAP, TFL shells, data specs.
▫ Outputs and programs (R)
▫ Database integration, study design, cohort building, outcome capturing, and analytics
Clinical Trials
Complaints/Vigilance
▫ Data coding and safety trends detection
CER · PSUR · SVR · PBRER
▫ AI generates an evidence integration strategy from your regulatory requirements
▫ Analysis pipelines spawn automatically based on the strategy
▫ Outputs aligned with EU MDR Annex III, MDCG guidance, and ICH E2C(R2)
▫ Regulatory-ready from first draft to Notified Body submission
Advanced Regulatory Reporting
What we deliver
Platform & Automation
Standalone workflows for each module and cross-module data linking
Integrated human validation and audit trails for regulatory use
AI models fine-tuned for client’s specific use-cases
Client’s specific code libraries
API to connect with other third-party tools
Security
HIPAA-compliant deployment on AWS Bedrock or on-premise
Role-based access control and audit trails
Technical Foundation
Built and hosted on AWS Bedrock
HIPAA Compliant: capability to receive identified patient data
Foundation Models: open-source (Llama, specialized small models)
Model operations and deployment
Fine tuned on proprietary domain data
Custom model training for specific use-cases
On-premise deployment options
Supports client-design
API connectivity to third-party AI platformsted models via API integration