End-to-end support throughout RBQM transformation
Bio Soft Research proposed and ongoing clinical trials with comprehensive RBQM support. Our team of seasoned industry data analysts will expertly configure the system on your behalf, meticulously processing your clinical trial and operational data to deliver insightful findings directly to you. We help pinpoint precisely where to concentrate active efforts, optimize clinical data quality, and secure the success of your trial.
> Adaptive Monitoring including monitoring plans
> Centralized Monitoring
> Study or site-level metrics and Risk Indicators (KRI) selection
> Deep-dive review of sites
> Guided decision-making on potential issues
** Study protocol risk assessment & mitigation **
Risk Assessment
Impact, probability, and detectability assessment
Risk Mitigations
Protocol-based mitigation actions
Protocol Amendments
Protocol optimization suggestions
Optimizing Study Protocols
Enhance the practicality and efficiency of your study Protocol. Bridge gap between Protocol development real – life execution risks by leveraging AI-augmented risk assessment support that aligns directly with risk-based quality management processes as per the most recent ICH GCP guidelines.
>> AI-Augmented Risk Assessment Aligned with ICH GCP Guidelines
Would you like to optimize in the area of:
> Protocol Risk Evaluation
- Assessing risk probability and detectability can be a challenging endeavor.
> Clinical Trial Process Compliance
- Gaps in risk assessment often lead to non-compliance.
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Explore how we can support you:
> RBQM Risk Scoring & Prioritization
- Utilize decades of risk-management experience in assessing risk impact, probability, and detectability.
> RBQM Process Transformation
- Allow us to align your study protocol with risk-based processes and create tailored mitigation actions.