amplified by AI
Vital Clinical Solutions is the fusion between quality, science, and technology to improve the efficiency and reliability of clinical trials.
Empowering TMF experts with AI tools to handle inspection readiness, study close-outs, CRO transitions, and ongoing quality control. Our experts direct HIPAA/GDPR-compliant AI to focus on the highest-risk areas based on study complexity and regulatory requirements.
The dynamic nature of trial documents and timelines makes ensuring TMF completeness a persistent challenge across all levels of expertise.
Our TMF experts direct our AI to focus on the highest-risk areas based on study complexity and regulatory requirements, maximising impact.
With years-long trials, staff turnover, and multiple CROs, consistent document organization is consistentily an overwhelming challenge.
Even the best TMF teams can manually review only a fraction of today’s complex files. Our AI expands that reach across the entire TMF.
Turn ICH E6(R3) compliance into competitive advantage.
We help you identify and control the operational factors that actually impact trial reliability.
Operational factors silently erode statistical power
Show how quality affects your ability to detect efficacy
ICH E6(R3) requires systematic QbD, not just lists of risk management activities
Transform QbD into actionable operational metrics
From initial assessment to actionable recommendations,
our systematic approach ensures nothing critical escapes review.
Evaluate current QC status and team readiness
Step 1
Determine parameters, sites, and focus areas
Step 2
AI analyzes, experts validate critical findings
Step 3
Deep-dive into patterns and risk areas
Step 4
Prioritized recommendations and remediation plan
Step 5