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Risk Based Quality Management

With a risk-based management approach, you have a better chance of ensuring site productivity and responding to site-specific issues before they become major problems. Statistical data checks, remote monitoring, risk assessment and categorization, automated alerting, and other RBQM techniques give you a powerful quality control solution that can supplement or even replace traditional site visits.

LSAC: Risk Based Quality Management

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  • EDC
  • CTMS
  • Safety
  • Financial
  • Site Performance
  • Trial Performance
  • Operations
  • Investigation
  • Lab
  • Biomarker

Governance • Curation • Harmonization Orchestration • Unified Data Model • Metrics Ad-Hoc Reporting • Conversational UX


Portfolio and Study Oversight

With real-time access to all your study data and a revolutionary Deep Learning Intelligent Assistant (DaLIA) that delivers immediate answers to thousands of common operational and clinical questions, it’s never been easier to track your study performance and ensure that milestones are met.


Risk Assessment and Categorization

Saama’s Risk Assessment and Categorization Tool (RACT) facilitates risk planning, assessment, and mitigation in a collaborative manner. A TransCelerate RACT Template is ready to use out of the box, or you can create your own custom templates. Either way, RACT is designed to help you identify and categorize risks, calculate the probability and impact of each risk, identify risk mitigation plans, and preview an overall risk score for each study.


Automated Threshold Breach Detection and Alerting

By setting predefined thresholds and receiving automatic alerts when those thresholds are breached, you can identify issues early—before they become major problems—and take corrective action much sooner and more effectively.


Remote Monitoring

The ability to evaluate study data remotely conserves valuable resources and eliminates the need for many site visits. Pharma companies that adapted to remote monitoring during the COVID-19 pandemic were able to keep important clinical trials on track.


Task and Workflow Management

Collaboration tools track decisions, actions, and outcomes in a fully auditable way.

Saama can put you on the fast track to clinical trial process innovation.