CluePoints

07/08/2026

Real-world data is only as valuable as it is trustworthy.

In her latest piece for PharmaLive, CluePoints Senior Strategic Consultant Sophie Henderson frames three shifts reshaping clinical research at once: the rise of real-world data, growing regulatory backing for risk-based approaches, and AI that unlocks insights at new scale.

Her point is that they're interlocking, not separate. As RWD increasingly supports regulatory submissions, its integrity can't be assumed. Risk-based quality management and centralized statistical monitoring offer a proven way to scan large, messy datasets for the outliers that matter, while AI takes on curating data that was never designed for clinical research.

And as Sophie makes clear, this isn't about buying one tool. It's about alignment, adapted processes, and upskilling teams so new approaches actually get adopted.

Read the full article here: https://hubs.ly/Q04sdH7t0

06/08/2026

"Prove the ROI" is where most RBQM conversations stall.

For years, the answer was "we believe it helps." On September 10, we're bringing the data.

Tufts CSDD and CluePoints are hosting a live webinar on the first peer-reviewed research to quantify the financial return of RBQM, now published in Therapeutic Innovation & Regulatory Science.

Using real-world data across 18 oncology trials, the study found:
→ 8 to 19% reductions in clinical phase durations
→ Returns of up to 23x the RBQM investment
→ Most of that value coming from time savings, not reduced monitoring spend

A session for anyone who needs to move RBQM from "good practice" to a defensible business decision.

Quantifying the Value Proposition of RBQM
September 10 | Virtual Event

Reserve your spot today: https://hubs.ly/Q04s5qj60

29/07/2026

When an inspection gets announced, most teams' first move isn't preparing the science. It's reconstructing the paper trail: which queries were raised, when, and what was decided across which studies.

The clinical judgment is almost always sound. The problem is the workflow. Most medical and safety review was never built to produce inspection-ready evidence as an output of the work, so oversight ends up scattered across trackers, email chains, and EDC logs that record data changes but not clinical interpretation.

Under ICH E6(R3), the question has moved from "did review happen?" to "can you show it was timely, proportionate, justified, and traceable?" Inspectors aren't questioning whether your monitors are good at their jobs. They're asking whether the weekly work produces a defensible record automatically, without a reconstruction effort to make it visible.

The teams making real progress aren't documenting more. They're building workflows where the audit trail is a natural output of each review cycle, not something assembled before inspection.

Read the full blog here: https://hubs.ly/Q04r9mgX0

27/07/2026

We're excited to welcome Martin "Marty" Magazzolo as CluePoints' new Chief Commercial Officer.

Marty joins us with more than 30 years of executive leadership across life sciences, healthcare technology, and data-driven services businesses, including recently as Chief Commercial Officer at Honeywell Life Sciences. He'll lead our global commercial organization as we continue scaling our Risk-Based Quality Management (RBQM) and data quality oversight solutions for sponsors and CROs worldwide.

Marty succeeds co-founder Pat Hughes, who built CluePoints' commercial organization from the ground up and is transitioning into a strategic advisory role, where he'll continue supporting our leadership team. Thank you, Pat, for everything you've built.

Welcome to the team, Marty!

Read the full announcement here: https://hubs.ly/Q04qQTz20

23/07/2026

AI is everywhere in clinical trials right now. The real question is how it fits into the risk-based model teams already rely on.

In the latest edition of Journal for Clinical Studies, Sophie Henderson, Senior Strategic Consultant at CluePoints, makes the case: the biggest gains don't come from AI alone. They come from a unified ecosystem: central statistical monitoring, intelligent query detection, and medical safety review working together, paired with the human expertise to act on it.

The market agrees. RBQM is projected to grow at a 12% CAGR through 2033, reaching roughly $7 billion. And as ICH E6(R3) pushes a unified, risk-based model, regulators are raising the bar on analytics-driven oversight.
Her takeaway: technology accelerates the work, but human intelligence is what turns it into value.

Where do you see AI making the biggest difference in your RBQM workflows?

Read the full article here:

Risk-based quality management (RBQM) is now widely recognised as crucial to improving data quality and clinical trial efficiency. Regulatory backing and

21/07/2026

Medical and safety review is one of the most consequential workflows in clinical development.

It also can be one of the least modernized.

Every trial under ICH-GCP requires it, running continuously from first patient in to last patient out. Yet in many organizations this process still runs on spreadsheets, disconnected systems, and email follow-up with little audit traceability.

The real issue isn't visibility. It's that reviewers spend the first hour of every cycle rebuilding context before they can even begin. A signal that surfaced on day one may not reach them until day twelve.

The fix isn't more dashboards. It's a different workflow.

Read the full blog here: https://hubs.ly/Q04q28Z70

10/07/2026

Cheers to a strong first half of 2026! 🥂 Our US team came together to raise a glass, celebrate the summer, and toast the milestones we've hit so far this year. Great work is worth celebrating—but it's the people behind it that make it special. Grateful for this crew, and onward to H2!

08/07/2026

Regulators used to ask: Did the review happen?

Now they're asking: Was it timely? Was it proportionate? Was it justified? Is it traceable?

Medical & Safety Review is one of the most consequential workflows in clinical development. Yet in many organizations, it's still one of the least modernized, run on Excel trackers, email chains, and manual navigation across disconnected systems.

The work hasn't changed. The expectations have.

Our new guide, Medical & Safety Review: From Event to Insight, breaks down how to move from activity-based to evidence-based oversight:

✔ Consolidated patient view across EDC, labs, AEs, meds, and history
✔ Change-based review that surfaces only what's new
✔ Insight to action, not insight to email
✔ Audit-ready by design, not reconstructed at inspection

Under ICH E6(R3), traceability isn't optional. See what a modern review workflow looks like.

Read the guide: https://hubs.ly/Q04nWdD60..

07/07/2026

CluePoints and Tufts Center for the Study of Drug Development have published the first peer-reviewed study quantifying the financial return of RBQM in clinical development.

RBQM-enabled trials demonstrated ROI multiples of up to 23x, eNPV gains of up to $13.8M at the program level, and 8–19% shorter clinical phase durations, based on real-world data from 18 oncology trials conducted on the CluePoints platform.

Read the press release and access the full paper below:

https://hubs.ly/Q04nKS4N0

04/07/2026

This 4th of July, we're grateful for the freedom to push boundaries, challenge the status quo, and work toward a future where clinical trials run smarter and patients benefit faster. Wishing you fireworks, good food, and quality time with the people who matter most. Happy Independence Day from all of us at CluePoints! ❤️💙