CluePoints

02/09/2026

For years the business case for RBQM ran on intuition. Most people agreed it should pay off. Almost nobody could put a number on it.

In part one of a new video series with Applied Clinical Trials, Sylviane de Viron of CluePoints and Abigail Dirks, MS of Tufts CSDD explain why that number has been so hard to produce, and what our peer-reviewed study in Therapeutic Innovation & Regulatory Science did differently.

What they discuss:

→ The timing trap: modeling ROI requires real-world deployment data, but leadership wants the ROI case before anyone has adopted at scale
→ How pairing CluePoints deployment data from 18 oncology trials with Tufts CSDD benchmarks and eNPV modeling closed that gap
→ Why oncology was chosen deliberately as the conservative case
→ What the model left on the table, including reduced rework, data integrity, and inspection readiness, and why that means the true value is likely higher

Watch part one here: https://hubs.ly/Q04wnm_H0

More from the series to come!

In this video interview, Sylviane de Viron of CluePoints and Abigail Dirks of Tufts CSDD explain how combining real-world deployment data with eNPV modeling finally made it possible to put a number on the financial value of RBQM—and why oncology was chosen as a conservative starting point.

02/09/2026

One week to go. Have you registered yet?

Join Tufts CSDD and CluePoints on September 10 for a live discussion of newly published, peer-reviewed research quantifying the financial value of RBQM.

Based on real-world data from 18 oncology trials, the research provides new evidence on how RBQM can accelerate clinical development and deliver measurable financial value.

What will the research reveal?
→ Up to 23x ROI from RBQM implementation
→ Clinical phase durations reduced by up to 19%
→ Why time savings can deliver greater value than monitoring cost reductions
→ Evidence to strengthen the business case for RBQM investment and wider adoption

📅 Thursday, September 10, 2026 9:00 AM ET

Don't forget to submit your question when you register. Selected questions will be answered live by our experts.

Register now to reserve your place: https://hubs.ly/Q04wh1vb0

01/09/2026

RBQM has reached a turning point. The question is no longer whether organizations should adopt risk-based approaches—it’s how to operationalize them effectively.

Join Ken Getz, Executive Director and Professor at Tufts CSDD, at for:

RBQM at a Turning Point: From Adoption to Operational Maturity

📅 October 7
⏰ 9:00–10:00 AM ET

Explore how regulatory developments, including ICH E6(R3), the rapid emergence of AI, and evolving oversight expectations are redefining the RBQM landscape.

Register today: https://hubs.ly/Q04w4QNM0

28/08/2026

RBQM may only be approved one trial at a time. The value shows up across the portfolio.

That mismatch is why adoption often stalls after a successful pilot. One study saves some weeks and some monitoring budget, which is easy to write off as noise. Run RBQM across a full development program and the numbers change character entirely.

New peer-reviewed research in Therapeutic Innovation & Regulatory Science models both levels. Using real-world data from 18 oncology trials and industry benchmarks from Tufts CSDD:

→ 8 to 19% reductions in clinical phase durations
→ ROI multiples of up to 23x
→ eNPV gains of up to $13.8M at the program level

The authors present the findings live on September 10, including what the evidence means for organizations trying to move RBQM from pilot to portfolio.

Reserve your spot today: https://hubs.ly/Q04vH1hy0

27/08/2026

Boston, here we come!

CluePoints is exhibiting at DPHARM 2026, and we’re ready to talk innovation in clinical trials.

Visit us at Booth #121 to connect with our team and explore how CluePoints is applying proven science and intelligent technology to help clinical teams rethink data review and oversight.

📅 September 15–16
📍 Boston, MA | Booth #121

See you at DPHARM!

27/08/2026

We're heading to SCDM 2026 in Raleigh.

Stop by CluePoints Booth #502 to talk with our team about clinical data review and risk-based quality management, and see how our platform works across the studies we support today.

📍 Booth #502 | Raleigh, NC
📅 September 15–17

We hope to see you there.

25/08/2026

The RBQMLive 2026 agenda is live.

Six years in, and the conversation has moved from "should we do RBQM" to "how do we prove it works." That shift shows up across all four sessions:

→ RBQM at a Turning Point: From Adoption to Operational Maturity
→ Beyond Adoption: Proving the Value of a Mature RBQM Program
→ Trusted AI in Clinical Operations: From Automation to Decision Intelligence
→ Designing Quality: From Inspection Readiness to Predicting Risk Before First Patient

October 7-8. Virtual. Free to attend.
See the full agenda and register here: https://hubs.ly/Q04vcd-Z0

24/08/2026

83% of sites improved trial quality when central statistical monitoring was applied. Only 56% improved without it.

In the Summer issue of International Clinical Trials, CluePoints' Laura Trotter breaks down how advanced analytics move risk detection earlier, catching signals traditional monitoring misses.

From CSM flagging under-reported adverse events to data quality assessment surfacing a problem site eight months before the study team spotted it, the case for early detection is getting harder to ignore.

She also looks at where LLMs and agent-based systems fit, adding context to statistical signals rather than replacing them.

Read Laura's article in the Summer issue of ICT, pages 132-134: https://hubs.ly/Q04tZMcB0

Welcome to ICT Summer 2026! Featuring articles on Alzheimer's and Neurology, Patient Retention and Technology in Clinical Trials. Plus, this edition includes our annual Clinical Trial Supply and Logistics supplement!

20/08/2026

We’re bringing the launch to the rooftop. 🎉

Join CluePoints at Urban Oak Rooftop Bar on Tuesday, September 15, as we celebrate the launch of Intelligent Query Detection (IQD), Medical & Safety Review (MSR), and Intelligent Medical Coding (IMC).

Come raise a glass, connect with clinical data leaders, and be part of the next chapter in Clinical Data Review.

📍 Urban Oak Rooftop Bar
🗓️ Tuesday, September 15
⏰ 7:30–10:30 PM

Register today: https://hubs.ly/Q04tH_z40

19/08/2026

We know RBQM improves oversight. But what's it actually worth?
In a new Q&A with ACRP, our own Sylviane de Viron (CluePoints) and Abigail Dirks (Tufts CSDD) break down the peer-reviewed research that puts real numbers to the financial case for risk-based quality management.

The headline findings:
→ Up to 23x ROI at the clinical trial level
→ 8 to 19% reductions in clinical phase durations
→ Up to 18% lower monitoring costs under a 10% SDV scenario

The biggest driver of value? Time saved. As the authors point out, protecting development timelines is one of the strongest strategic levers sponsors have, and RBQM delivers on it.

Read the full Q&A here: https://hubs.ly/Q04tx6Lk0

While risk-based quality management has gained increasing acceptance across the clinical research enterprise, quantitative evidence on its financial impact has been limited. A new analysis coauthored by experts from CluePoints and the Tufts Center for the Study of Drug Development addresses this gap...