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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.
Fact Sheet

LSAC: Risk Based Quality Management

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  • EDC
  • CTMS
  • Safety
  • Financial
  • IRT/IVRS RTSM
  • Site Performance
  • Trial Performance
  • Operations
  • Investigation
  • Lab
  • Biomarker

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

Use Cases/Value Drivers

  1. Portfolio and Study Oversight
  2. Risk Assessment and Categorization
  3. Automated Threshold Breach Detection and Alerting
  4. Remote Monitoring
  5. Task and Workflow Management
 

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.

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Terms & Conditions

By inquiring about Saama’s Database Lock in a Day, you agree to be contacted by Saama and to allow Saama to use, maintain, store, and protect your personal data in accordance with our Privacy Policy.

Eligibility details are for informational purposes only. Saama, in its sole discretion, will determine your eligibility based on the information you disclose as part of the intake process. If Saama determines that you are eligible to participate, you will be notified by separate email. Eligibility depends on certain criteria, such as the size of your company, the types of clinical trials you sponsor, and the number of patients in–and stages of–your current clinical trials.

By completing the request form, you represent that you have authority to proceed on behalf of your company. Should you agree to participate, you agree to reasonably cooperate with Saama in following the guidelines and procedures required for integrating, standardizing, and analyzing your data. Participation requires the use of our Smart Data Quality application, a technology-agnostic AI engine that sits on top of your current infrastructure. The application can be used immediately, and you’re only charged for the services you use based on a predetermined estimate.

Information you share with Saama during your participation may be anonymized and/or aggregated, and made available publicly in Saama marketing materials. This information may include: types of systems and processes involved, types of departments involved, and size and regional location of your company. Such information will never be directly associated with you, nor will you or your company be identifiable without express written permission.