Innovation in Action – Projects That Shape RBQM’s Future

From EU-funded AI research to co-authored publications with leading sponsors, we explore how responsible technology improves quality, predictability, and oversight in clinical trials.

Innovation in Action — Projects That Shape RBQM’s Future

From EU-funded AI research to co-authored publications with leading sponsors, we explore how responsible technology improves quality, predictability, and oversight in clinical trials.

RBQM Innovation Projects

AI & Analytics

Risk & Quality Science

Operational Performance

Microsoft Healthcare AI Certification

Validation of AI-supported oversight for enterprise-grade security, reproducibility, and traceable decision support — ensuring AI remains compliant and human-controlled.
→ Learn About Responsible AI

Mannheim Technical University

Joint validation of GxP-ready large-language models to ensure AI outputs remain clinically interpretable, explainable, and inspector-defensible.
→ Explore the Initiative

PUEKS Study

Evidence-based ground rules for RBQM: what accelerates adoption — and what blocks it — across TODAY’s clinical operations.
→ See Early Findings

RBQM in Rare Disease Trials (Poster)

Observational patterns showing where signal detection must adapt when populations are small and variability is high.
→ Download Poster

CRF Design for RBQM (Poster)

Bringing risk early into CRF design to reduce avoidable protocol deviations downstream.
→ Download Poster

Supply Chain Risk Intelligence Pilot

Applying RBQM principles beyond trial conduct — preventing temperature excursion risk in air-freight biologics transport.
→ See the Approach

AI-TRIAL with Fraunhofer / LOEWE

Predictive metrics 12+ months ahead — accelerating resourcing decisions and reducing study delays.
→ Discover AI-TRIAL

Responsible AI — Built for Clinical Oversight

AI that supports human judgment — never replaces it.

Our validation approach ensures that predictive and generative models remain explainable, traceable, and GxP-defensible:

Validated with academic research partners (e.g., Mannheim Technical University)
Independently recognized through Microsoft Healthcare AI certification
Full reasoning traceability to show what changed — and why
Designed to meet ICH E6(R3) and E8(R1) expectations

Where RBQM Thought Leadership Happens

We convene the industry’s decision-makers to drive new standards and operational reality.

“I was delighted that there were quite some international participants from big players in Pharma that shared their insights. It was a very relaxed and authentic atmosphere.”

— Leadership Roundtable Attendee, Frankfurt (Germany), 2025

Responsible AI in Clinical Trials Summit

Global forum where regulators, sponsors, and CROs shape how AI enters GCP-compliant practice.

In-Person Leadership Roundtables

Focused, small-group dialogues where leaders can connect meaningfully and drive practical oversight progress.

“It was a great meeting to learn more about QbB and impact of AI. It gave me a chance to meet with experts from their field.”

— Leadership Roundtable Attendee, Frankfurt (Germany), 2025

Ready to Co-Create RBQM Progress?

Whether you bring real-world data, scientific expertise, or operational scale — together we deliver oversight that stands up to inspection and real-life complexity.