Happy Biotech - From Toilets to Trials: The Weirdest Things That End Up on a Risk Register

Happy Biotech - From Toilets to Trials: The Weirdest Things That End Up on a Risk Register

What do clinical trials and broken office toilets have in common? Apparently, a risk register. In this episode, we unpack how risk management really works in clinical operations—likelihood, impact, and when to mitigate versus move on—while sharing a true story about bathroom plumbing ending up on an R&D risk log, plus a debate on whether unhealthy cafeteria food is a “risk” or just an issue pretending to be one.

From Molars to Metadata - TMF Tales with Pooja

Pooja Khemchandani joins Happy Biotech to share her journey from dentistry in India to TMF leadership in biotech. She breaks down what TMF health really means, how sponsor-side work differs from CROs, why the industry struggles with adopting new tech, and how automation and AI could reshape documentation. She also drops a spooky TMF story (yes—menus and hand scans happen) and reminds us of the ultimate rule: if it’s not documented, it doesn’t exist.

Conferencing Standards: From CDISC to Chicken & Waffles - Inside the push to standardize TMFs—and rediscovering the human side of biotech.

Micah returns to the conference world after twenty years, diving into the CDISC/TMF Interchange in Nashville. From acronyms to alignment debates, Suus and Micah unpack how the industry’s drive for standards collides with the messy, very human side of collaboration. Along the way: networking hacks, risk logs, Dutch “poldering,” and yes—chicken and waffles.

ICF: The Most Important Thing You’ll Never Read Twice

Micah and Suus unpack the informed consent form—what it is, why it exists, and how IRBs/ECs shape it—plus the new plain-language summary trend, vulnerable-population rules, translations, and version updates when protocols or safety data change. Short, readable, and actually useful… unlike most fine print.

Black Roses, Paper CRFs & the Drama of Doing Good

From three-ply CRFs to three dudes and a compound, Doris Sánchez joins Suus and Micah for a candid tour of biotech’s real backstage: why passion (and sane meeting habits) matter, how consulting buys back your time, and the wild CRA tale that arrived with a black rose and a half-smoked cigarette. We also swap myth-busting takes on “Big Pharma,” burnout, and a foodie detour to Boston’s La Bodega.