Justin Yamashita

Benchtop, site, CRO. Three levels of basic and clinical research, explained without spin

Open Site File

Oct 8, 2026

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8 min read

Why Consent Is a Document | The Open Site File #17

Four kinds of instrument, one form, and a gap between two halves of the US system that is still open.

Justin Yamashita

Big Wellness

Are Supplements FDA Approved? Who Actually Checks Them, and When | Plain Talk, Issue 026

Oct 7, 2026

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6 min read

Are Supplements FDA Approved? Who Actually Checks Them, and When | Plain Talk, Issue 026

Small Doses, No. 2: a supplement can reach the shelf without any FDA review. Here's how problems get caught instead.

Justin Yamashita

Open Site File

Oct 6, 2026

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8 min read

What Happens When a Patient Misses a Study Visit | The Open Site File #16

What a visit window is, and what happens when you miss one.

Justin Yamashita

The Root Room

Oct 5, 2026

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7 min read

Are Supplements Safe Because They're Sold in Stores? The Talk, and the List Your Doctor Needs | The Root Room, Issue 026

Ray's counter has 11 bottles on it and his doctor knows about none of them. Watch his daughter raise it without a lecture.

Justin Yamashita

Open Site File

Oct 2, 2026

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7 min read

Clinical Research Careers for Foreign-Trained Doctors | The Open Site File #15

Which roles value a medical degree earned abroad, and what does not translate on paper.

Justin Yamashita

Peptides

Sep 30, 2026

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8 min read

Peptides Explained: BPC-157, the Longevity Hype, and the Missing Human Trials | Plain Talk, Issue 025

Small Doses, No. 1: what peptides are, what's been tested in people, where the FDA stands, and the questions to decide for yourself.

Justin Yamashita

Open Site File

Sep 29, 2026

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7 min read

What Counts as a Protocol Deviation | The Open Site File #14

Why a visit 2 days late is a regulatory event.

Justin Yamashita

The Root Room

Sep 28, 2026

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7 min read

Anti-Aging Peptides: What the Longevity Pitch Leaves Out | The Root Room, Issue 025

A smart woman, a longevity clinic, and a vial with almost no human trials behind it. Watch the pitch work, then decide for yourself.

Justin Yamashita

Open Site File

Sep 25, 2026

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6 min read

GCP Has a Version Number, and Yours Might Be Out of Date | The Open Site File #13

What changed at each version of ICH E6, and how to tell which one you were trained on.

Justin Yamashita

Peptides

R2Rx Issue 024 Plain Talk: Who Checks the Room Your Medicine Is Made In?

Sep 23, 2026

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5 min read

R2Rx Issue 024 Plain Talk: Who Checks the Room Your Medicine Is Made In?

The label tells you the molecule. It never tells you the floor it came off of, and that is the part that killed 64 people.

Justin Yamashita

Open Site File

Sep 22, 2026

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5 min read

Why Sites Get Data Queries and What They Mean | The Open Site File #12

Eleven queries on one visit. Nine were fair. The two that were not took longer.

Justin Yamashita

The Root Room

Sep 21, 2026

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3 min read

R2Rx Issue 024 The Root Room: Iris Walks the Manufacturing Floor

Iris expects a factory. What she gets is a room where a single missed cleaning log can be the difference between a batch that ships and a batch that doesn't exist.

Justin Yamashita

Open Site File

Sep 18, 2026

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10 min read

What a Clinical Research Coordinator Does All Day | The Open Site File #11

Where a coordinator's hours actually go, ranked by time rather than by glamour. Written for people deciding whether this job is what they think it is.

Justin Yamashita

Clinical Trials

R2Rx Issue 023 The Informed: The Board That Recommends, and the Board That Cannot Watch

Sep 17, 2026

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13 min read

R2Rx Issue 023 The Informed: The Board That Recommends, and the Board That Cannot Watch

The regulation behind IRB and data monitoring committee oversight, the office that enforces it and what has happened to it, the deregulatory rewrite that is queued, the full Women's Health Initiative numbers, and every citation.

Justin Yamashita

IRB

R2Rx Issue 023 Plain Talk: Two Inspectors, Not One

Sep 16, 2026

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9 min read

R2Rx Issue 023 Plain Talk: Two Inspectors, Not One

One board clears a trial before anyone enrolls. A second one watches the data while it runs. Neither works for the people running the study, and only one of them is actually required.

Justin Yamashita

Open Site File

Sep 15, 2026

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5 min read

What Source Documents Are in Clinical Research | The Open Site File #10

What counts as source, and why the first place a fact was written down wins.

Justin Yamashita

The Root Room

R2Rx Issue 023 Root Room: The Room You Are Not Allowed to Sit In

Sep 14, 2026

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8 min read

R2Rx Issue 023 Root Room: The Room You Are Not Allowed to Sit In

A husband wants to know who’s actually watching his wife's trial. The answer is a meeting nobody at the trial is allowed into, including the people running it.

Justin Yamashita

Open Site File

Sep 11, 2026

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8 min read

Clinical Research Jobs You Can Get With a Biology Degree | The Open Site File #9

Hardly anyone ends up in clinical research on purpose, but it makes for a great combination of knowledge and skills across our colleagues

Justin Yamashita

Clinical Trials

R2Rx Issue 022 The Informed: Same Dose, Different Body

Sep 10, 2026

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15 min read

R2Rx Issue 022 The Informed: Same Dose, Different Body

For 76 of 86 drugs with sex specific data, the same dose produced higher exposure in women. Among the drugs already known to hit one sex harder, that exposure gap predicted which sex 88% of the time.

Justin Yamashita

Clinical Trials

Sep 9, 2026

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14 min read

R2Rx Issue 022 Plain Talk: Sex, Ancestry, Diversity, and Clinical Trials

Exposure: who the dose was actually set for.

Justin Yamashita

Open Site File

Sep 8, 2026

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5 min read

What Happens During a Clinical Trial Monitoring Visit | The Open Site File #8

Who a CRA is, what they do, and what happens when they visit

Justin Yamashita

The Root Room

R2Rx Issue 022 Root Room: The Feasibility Strategy and Twelve Sites

Sep 7, 2026

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9 min read

R2Rx Issue 022 Root Room: The Feasibility Strategy and Twelve Sites

Sam expects a villain's lair. What Sam finds is a map, a calendar, and two people who both have a point.

Justin Yamashita

The Informed

Sep 3, 2026

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5 min read

R2Rx Issue 021 The Informed: What Actually Replaces a Mouse

The FDA didn't ban animal testing. It's dismantling the reason to keep relying on it, one guidance document at a time.

Justin Yamashita

Peptides

R2Rx Issue 021 Plain Talk: The Best Guess We Had

Sep 2, 2026

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12 min read

R2Rx Issue 021 Plain Talk: The Best Guess We Had

The real reason drug testing leaned on animals for 80 years has nothing to do with cruelty. It has to do with what else there was.

Justin Yamashita

Open Site File

Sep 1, 2026

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6 min read

How Causality Is Decided in a Clinical Trial | The Open Site File #7

How a clinical research site actually runs, behind the locked door.

Justin Yamashita

Justin Yamashita

Why Consent Is a Document | The Open Site File #17

Are Supplements FDA Approved? Who Actually Checks Them, and When | Plain Talk, Issue 026

What Happens When a Patient Misses a Study Visit | The Open Site File #16

Are Supplements Safe Because They're Sold in Stores? The Talk, and the List Your Doctor Needs | The Root Room, Issue 026

Clinical Research Careers for Foreign-Trained Doctors | The Open Site File #15

Peptides Explained: BPC-157, the Longevity Hype, and the Missing Human Trials | Plain Talk, Issue 025

What Counts as a Protocol Deviation | The Open Site File #14

Anti-Aging Peptides: What the Longevity Pitch Leaves Out | The Root Room, Issue 025

GCP Has a Version Number, and Yours Might Be Out of Date | The Open Site File #13

R2Rx Issue 024 Plain Talk: Who Checks the Room Your Medicine Is Made In?

Why Sites Get Data Queries and What They Mean | The Open Site File #12

R2Rx Issue 024 The Root Room: Iris Walks the Manufacturing Floor

What a Clinical Research Coordinator Does All Day | The Open Site File #11

R2Rx Issue 023 The Informed: The Board That Recommends, and the Board That Cannot Watch

R2Rx Issue 023 Plain Talk: Two Inspectors, Not One

What Source Documents Are in Clinical Research | The Open Site File #10

R2Rx Issue 023 Root Room: The Room You Are Not Allowed to Sit In

Clinical Research Jobs You Can Get With a Biology Degree | The Open Site File #9

R2Rx Issue 022 The Informed: Same Dose, Different Body

R2Rx Issue 022 Plain Talk: Sex, Ancestry, Diversity, and Clinical Trials

What Happens During a Clinical Trial Monitoring Visit | The Open Site File #8

R2Rx Issue 022 Root Room: The Feasibility Strategy and Twelve Sites

R2Rx Issue 021 The Informed: What Actually Replaces a Mouse

R2Rx Issue 021 Plain Talk: The Best Guess We Had

How Causality Is Decided in a Clinical Trial | The Open Site File #7

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