Chris McSpiritt

Business architect and data geek with a passion for empowering life sciences companies to do more.

[Chris McSpiritt @mcspiritt]

HHS Just Named the Clinical Trial Speed Problem https://t.co/vhWIZ5EzHF

[Chris McSpiritt @mcspiritt]

View my verified achievement from @GoogleCloudTech. https://t.co/GSNpCciB7g via @credly

[Chris McSpiritt @mcspiritt]

Public dockets are public.

The useful signal will not be whether a company can say "AI-enabled trial optimization" in a deck. Everyone can.

The signal will be which functions can put their architecture on the record by June 29.

That is the diagnostic.

[Chris McSpiritt @mcspiritt]

The FDA RFI window did not close on May 29.

It moved to June 29.

That extension is not administrative housekeeping. It is a diagnostic.

[Chris McSpiritt @mcspiritt]

The extra month separates two kinds of organizations.

The ones that needed more time to write a substantive position.

And the ones that needed more time to realize they did not have one.

[Chris McSpiritt @mcspiritt]

Anthropic buying a biotech AI startup is not just a discovery story.

It is a throughput story.

If model companies make biology move faster, the pressure moves downstream: protocol design, site activation, data quality.

Discovery got faster. Execution has to catch up.

[Chris McSpiritt @mcspiritt]

A third of the procedures in your Phase III protocol don't support an endpoint.

That number is from Tufts and TransCelerate. It's not an execution problem.

Operations didn't write the protocol. They got handed it and asked why enrollment is slow.

You can't fix in execution what was overbuilt in design.

[Chris McSpiritt @mcspiritt]

Check out my latest article: Three Questions the Agentic AI Wave Hasn't Answered Yet https://t.co/E9HUEnVmPY via @LinkedIn

[Chris McSpiritt @mcspiritt]

@Jacobsklug OS

[Chris McSpiritt @mcspiritt]

The UI was never the moat in clinical development.

The moat was the operating logic nobody documented well enough to move.

That is the part headless software conversations keep missing.

Open the APIs. Let agents read the data. Let them write back to the source of truth. Take humans out of the swivel-chair work.

But clinical development is not sticky because people love clicking through EDC, CTMS, eTMF, IRT, and safety systems. It is sticky because those systems have become containers for process and institutional memory.

And most of that memory is not actually in the system.
It lives in the study team member who knows which exception will become a finding. It lives in the data manager who knows the reconciliation rule the SOP does not quite explain.

That is what agents need before they can safely act. Not just access — context, boundaries, and the judgment to know when the happy path has ended.

That is not an IT cleanup exercise. It is operating model work. It is the work of writing down what your best people actually know and what your process actually does, not what the SOP says it does.

If your process knowledge lives in tribal memory and workaround culture, an agent will not modernize it. It will expose how much of the current operating model depends on humans quietly preventing the system from failing.

Maybe that is the useful part.

Agentic workflows force a level of honesty clinical organizations have avoided for years. They make you ask what the system actually knows, what only your best people know, and what nobody has been willing to write down.

Because writing it down would reveal how fragile the process is.

The next generation of clinical systems will not win because they hide the UI better. They will win because they make the operating logic visible enough that humans and agents can share the work without breaking it.

[Seema Amble @seema_amble]

https://t.co/o3nHSGDlUb

[Chris McSpiritt @mcspiritt]

@businessbarista AI-native

[Chris McSpiritt @mcspiritt]

Love this article - we all need to make the active choice to be builders - ideas aren't enough anymore.

[kiruwaaaa @kiruwaaaaaa]

https://t.co/EMK70w3eQQ

[Dr. Marty Makary @DrMakaryFDA]

A milestone day for clinical trial innovation.

We’re announcing the first real-time clinical trials, where @US_FDA can see data signals and endpoints in real time. A quick explainer:

[Chris McSpiritt @mcspiritt]

The AI governance conversation in life sciences right now: frameworks, guardrails, human-in-the-loop, audit trails.

Number of published case studies where one of these frameworks was actually tested by an inspector or a failure: zero.

The only stress test we have is the Purolea warning letter — and that's an example of what happens with no governance at all.

We're somewhere between "nothing" and "works under pressure" and calling it progress. It's documentation pretending to be governance.

[Chris McSpiritt @mcspiritt]

CRA AI agents: "8 hours saved per CRA per week."

Two possible futures: Fewer sites per CRA → better monitoring More sites per CRA → cheaper monitoring

Every vendor promises the first. Every CFO sees the second. The CRA doesn't get to choose.

We've seen this movie before. EDC was supposed to free data managers for deeper review. It freed their headcount lines.

[Chris McSpiritt @mcspiritt]

Check out my latest article: If You Want Better Clinical AI, Start With Better Data Architecture https://t.co/C7RpSrZXA4 via @LinkedIn

[Chris McSpiritt @mcspiritt]

We keep calling protocol amendments an operational problem. They're a design problem.

76% of trials require them. The amendment is the receipt for the protocol design meeting where nobody had the authority — or the incentive — to say no.

[Chris McSpiritt @mcspiritt]

@workspacesxyz @autonomous_labs @DomerChris2001 @scrumbasics

[Workspaces @workspacesxyz]

🚨 GIVEAWAY ALERT

We're giving away 2x ErgoChair Pro - Autonomous' most popular ergonomic chair

Easy entry:

1. Follow @workspacesxyz + @autonomous_labs
2. Like & RT
3. Tag 2 friends you'd love to share this with
4. Subscribe https://t.co/Rpda3QPUNn

Ends Apr 15 - good luck!