TMF Expert Insights
Thursday, July 30, 2026 | 4:26 AM
For someone who has never sat in the room, it's hard to picture what a TMF Roadshow actually is. A sales pitch? A webinar with better coffee? It’s neither.
I've presented at every TMF Roadshow we've run, and to me they're educational, plain and simple. We put these roadshows together to help people understand what's going on in the industry, not to sell them a system. There are no full product demos and no pitch decks disguised as workshops, just half a day of free, practical learning built for TMF managers, clinical research professionals, and anyone who touches a Trial Master File in their daily work.
That distinction matters more than it sounds. Our industry is mid-shift right now, and we started these roadshows to help people understand what's changing before they're expected to respond to it.
Where TMF Management Gets Complicated
If you ask me for the single biggest challenge in Trial Master File management right now, I won't give you a single answer, because there isn't one. Geography changes everything. In Asia Pacific and several European countries, plenty of sponsors still run paper-based TMFs, meaning someone has to physically be in a room to review a file, since remote access simply isn't possible. Archiving is its own cost, but that applies whether the TMF is paper or electronic. In Denmark and other parts of Europe, the pain point shifts to reconciliation: when a CRO hands a completed TMF back to the sponsor, that sponsor has to check, organize, and store it for 25 years.
Small biotech companies face their own version of this. A company might be acquired mid-trial, or a drug simply doesn't pan out and the company shuts down altogether, leaving uncertainty about who is responsible for long-term record retention. Add the complexity of migrating data between systems during a merger or an end-of-study transfer, then layer on the new risk-based approach introduced in ICH E6(R3), and it's easy to see why I so often hear, "I don't know where to file that."
That's exactly the kind of uncertainty the TMF Roadshows are designed to address. Each session explores practical ways to spot risk early, whether it's a pivotal study, a long list of stakeholders, or frequent protocol amendments.
Melbourne and the US: Different Audiences, One TMF Standard Model
The upcoming stops aren't one-size-fits-all, and we plan every agenda with that in mind. Melbourne's session is shaped around site-level attendees, since Australia has become a popular destination for phase one studies. I'll be speaking directly to the Investigator Site File model released last year, and how it fits into the broader TMF standard model taking shape for next year.
The US audience is a little different. TMF management is generally more mature there, so those sessions focus on AI's growing role and how organizations can prepare as the TMF Reference Model nears release. This October, our US tour includes a larger two-day event along with one additional roadshow stop, and I'm already looking forward to the conversations we'll have.
A Personal Project, Three Years In
These roadshows began with a simple idea that came out of a brainstorming session between our UK Sales team, me, and the TransPerfect Client Solutions Director: get out, talk to people about TMFs, and see what happens. Three years later, what started as a single event in London has grown into a global series, and I couldn't be prouder.
What means the most to me is watching more of our own experts take the stage alongside me, including Avani Amin and Laurel Ann Schrader in the US. Some of my favorite moments come from attendees sharing real inspection stories or taking part in the TMF quizzes that have become a highlight of our European sessions.
If there's one thing I want every attendee to leave with, it's this: don't panic about the TMF standard model. Change is coming, but nobody has to navigate it alone. I'm one of many consultants and standard model contributors out there whose job is to help teams understand what’s changing and put it into practice.
Next up, I'll be in Melbourne, Australia, followed by two roadshows across the US this October. Attendance is free, sessions run half a day, and the only thing I ask is that you bring your curiosity about where TMF management is headed next. Come save your seat, and let's talk TMFs:
