CluePoints

08/10/2026

Day 2 of RBQMLive 2026 is today.

Day 1 covered where RBQM stands and how to prove its value. Day 2 looks ahead: how AI earns trust in clinical operations, and how quality gets designed in before first patient in. Join us for:

→ 9:00 AM ET / 15:00 CEST: Trusted AI in Clinical Operations: From Automation to Decision Intelligence, with Brian Barnes (BioNTech) and Cris McDavid (Parexel)
→ 10:00 AM ET / 16:00 CEST: Designing Quality: From Inspection Readiness to Predicting Risk Before First Patient, with Kris Luypaert (Merck KGaA) and Tom Whitman (Biogen)

📅 Thursday, October 8 | 💻 Virtual and free to attend

There's still time to register: https://hubs.ly/Q04zCLpX0

06/10/2026

When an RBQM implementation underdelivers, the technology usually takes the blame. Wrong platform. Unclear dashboards. A vendor that overpromised.

Fred Blais sees it differently. In his new article for Pharmaceutical Executive, he makes the case that in most of the cases he has examined, the software did exactly what it was told to do. The problem was the human environment around it, which was never engineered.

Fred has looked at this problem from more than one seat:
→ As a Clinical Research Associate
→ Inside sponsor organizations
→ Now as an advisor

If your organization is considering a new platform to fix an implementation that didn't deliver, read this first.

Read the full article: https://hubs.ly/Q04zhX_90

RBQM implementations fail not because the software is wrong — but because the human environment surrounding it was never engineered.

05/10/2026

Last week, our Belgium team stepped out of the office for a litter pick-up around our New Tech Center offices and Einstein Park in Louvain-la-Neuve. In just 30 minutes, the team collected over 13 bags of rubbish and plastic.

It was a short effort, but a useful reminder of how much waste collects along the roads and paths we walk past every day.

Thank you to everyone who gave up part of their morning to pitch in. Lunch afterward was well earned. 🌍♻️

05/10/2026

Most RBQM programs don't stall because of the technology. They stall because the processes, roles, and habits around it never change.

Next week at SCOPE Europe, Fred Blais, RBQM Lead at CluePoints, takes on that gap in his session, "RBQM & Change Management: The Marriage We Keep Avoiding."

Expect a practical look at:
→ Why risk assessments and KRIs don't always turn into consistent decisions
→ The ownership, process, and resistance issues that keep RBQM from scaling
→ What it takes to make RBQM part of how teams actually work

📅 October 13, 3:55 to 4:20pm CEST
📍 InterContinental, Barcelona

If you're attending, add it to your agenda and come say hello to the CluePoints team at Booth #59.

02/10/2026

Less than a week to go until Day 2 of RBQMLive 2026!

We'll open with a look at trusted AI in clinical operations. Brian Barnes, Director, Risk-Based Quality Management at BioNTech, and Cris McDavid, Executive Director, Global Clinical Data, RBQM and IDD at Parexel, will share how sponsors are moving from automation to decision intelligence, and what it takes to bring AI into regulated clinical processes with governance and human oversight intact.

They'll be followed by Kris Luypaert, Inspection Excellence Lead at Merck KGaA, and Tom Whitman, Associate Director, Quality Systems & Technology at Biogen, who will explore how teams are using historical data and protocol intelligence to predict quality risk, and design it out before first patient in.

📅 Thursday, October 8
🕘 9:00 - 11:00 AM ET | 15:00 - 17:00 CEST

Can't make it live? Your registration includes on-demand access to the session recordings, released within 48 hours.

Register today: https://hubs.ly/Q04z2fTt0

01/10/2026

Less than a week to go until Day 1 of RBQMLive 2026!

Ken Getz, Executive Director & Professor at Tufts CSDD, will open with where RBQM stands today, and how ICH E6(R3), AI, and shifting sponsor expectations are redefining what "mature" means.

He'll be followed by Miguel Valenzuela, Director, Clinical Risk & Analytics at Alnylam; Jamie O'Neill, RBQM Contributor; and Demi You, Head of RBM at Sanofi. Together, they'll share how leading sponsors build and defend the business case for RBQM, and which metrics land with finance and quality leaders.

📅 Wednesday, October 7
🕘 9:00 - 11:00 AM ET | 15:00 - 17:00 CEST

Can't make it live? Your registration includes on-demand access to the session recordings, released within 48 hours.

Register today: https://hubs.ly/Q04yWJGF0

30/09/2026

One week until RBQMLive 2026. There's still time to save your spot.

E6(R3) is in effect, budgets are under scrutiny, and AI is moving into clinical operations at a rapid pace. RBQMLive tackles the four questions that can't wait:

→ What operational maturity actually looks like under ICH E6(R3)
→ How to prove RBQM's business value to leadership
→ Where AI belongs in clinical operations, and where it doesn't
→ How to design quality in from the protocol stage

Two days. Four sessions. Speakers from sponsors, CROs, academia, and technology who are running mature RBQM programs right now.

Can't make both days? Register anyway to get the on-demand recordings sent to your inbox.

Save your spot today: https://hubs.ly/Q04yLpz00

29/09/2026

Two weeks until SCOPE Europe.

CluePoints is exhibiting at the 9th Annual SCOPE Europe in Barcelona. Stop by Booth 59 to talk with our team about risk-based quality management, clinical data review, and what better oversight looks like on the studies you are running right now.

📅 October 13-14, 2026
📍 InterContinental Barcelona | Booth 59

See you in Barcelona.

28/09/2026

AI in clinical development has cleared the pilot stage. What it has not cleared is the evidence bar.

Session 3 at works through what responsible implementation actually requires, start to finish.

→ Decision support, not just automation: where AI changes the call, not only the workload
→ Human in the loop: who reviews what, and who is accountable when the model is wrong
→ Validation and governance: what regulators expect from a model running in a live process
→ Explainability, audit trails and continuous monitoring: being able to show your work months later
→ Vendor expectations: the transparency, data sources, integration and oversight sponsors should require before anything touches a study

Brian Barnes, BioNTech
Cris McDavid, Parexel
Moderated by Paul MacDonald, CluePoints

Trusted AI in Clinical Operations: From Automation to Decision Intelligence
Thursday, October 8 | 9:00-10:00 AM ET | Free and virtual

Register today: https://hubs.ly/Q04yt0Hs0

24/09/2026

Most organizations have implemented RBQM. Far fewer can say what it's worth.

Session 2 at is about closing that gap — how leading sponsors move a program past compliance and prove the return.

Demi You, Head of RBM, Sanofi
Miguel Valenzuela, Director of Clinical Risk & Analytics, Alnylam
Jamie O'Neill, RBQM Contributor

The questions on the table:

→ Who owns the program — and what happens to it when they move on?
→ How do you get clinical ops, data management and quality pulling in the same direction?
→ What breaks when you scale from a handful of studies to a portfolio?
→ Which numbers actually land with finance?

Beyond Adoption: Proving the Value of a Mature RBQM Program
Wednesday, October 7 | 10:00–11:00 AM ET | Free and virtual

Register today: https://hubs.ly/Q04yg5h70