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Clinical Trials & Flusso Domain Glossary

A working reference for the concepts, systems, and frameworks that come up in conversations with biotech CFOs, clinical operations leaders, and partner BD teams — and how each relates to Flusso's positioning.

Purpose. Make every term Joe, Ben, or any member of the Flusso team uses in front of a customer (or in a deck) consistent, defensible, and well-defined. Pre-read for any conversation that involves multi-CRO, multi-EDC, multi-partner clinical operations.

Scope. Concepts that are clinical-trial-domain-specific, eClinical-stack-specific, or Flusso-positioning-specific. Not a general business or technology glossary. Where a term has a Flusso-specific positioning angle, the entry includes a "Where Flusso fits" section.

Living document. This glossary is built up as concepts arise in customer conversations. New entries are added as the team encounters new terms; existing entries are deepened as positioning sharpens. Contribution conventions are at the bottom.

Topic Files

File Coverage Entry count
Partnerships & Milestones Evidence packets, milestone payments (development / regulatory / commercial / discovery), strategic investments, co-development, options, royalties, in-/out-licensing, JVs 12
Trial Governance & Oversight JSC, JOC, SRC, DSMB/IDMC, sponsor/PI/sub-investigator roles, IITs, sponsor-investigator, ethics committees (HREC/IRB), SMOs, CROs 10
Trial Operations Site activation, enrolment velocity, FPI/LPI/LPO, SIVs, database lock, SDV, queries, protocol amendments, protocol deviations, RBM, cycle time 11
Regulatory IND/NDA/BLA/MAA, CTA, FDA Type A/B/C meetings, Project Optimus, ICH-GCP, 21 CFR Part 11, GxP family, CSV, pharmacovigilance, major regulatory authorities 10
Data & Technology eClinical, CTMS, EDC, eTMF, CDISC standards (SDTM/ADaM/ODM), HL7/FHIR, REDCap, Veeva Vault, Medidata Rave, Oracle Health Sciences, SSOT, data residency 12
Statistics & Methodology Power analysis, sample size, adaptive design, MTD vs RP2D, oncology endpoints (ORR/PFS/OS/DCR/DOR), MSS vs MSI-H, exploratory vs confirmatory, log-rank/Cox, Bayesian vs frequentist, Operational Qualification (OQ) 10
RDTI & Australian R&D Context RDTI overview, 43.5% refundable offset, eligible R&D activity, Core vs Supporting Activities, Knowledge Areas, AusIndustry/DISR/ATO, Tax Promoter Penalty regime, aggregated turnover threshold, registration vs claim 9
Oncology & Clinical Context SAFEbody/NEObody/POWERbody, masked antibodies / conditional activation, TME, T-cell engagers, ADCs, CTLA-4/PD-1/PD-L1/CD137/CD20, Treg depletion, common cancer indications, neoadjuvant/adjuvant/metastatic settings, combination therapy 10

Total entries: ~84.

Full Term Index (Alphabetical)

A

B

C

D

E

F

G

H

I

J

K

L

M

N

O

P

Q

R

S

T

V

4

2

How to Use This Glossary

Before a customer call. Skim the relevant topic file(s) for the audience: CFO conversations → partnerships-and-milestones + trial-operations + RDTI; clinical operations leader → trial-operations + governance + data-and-technology; clinical development EVP → statistics-and-methodology + regulatory; BD lead → partnerships-and-milestones + oncology-clinical-context.

During deck preparation. When drafting deck content, hyperlink terms to their glossary entries so the deck author and reviewers can verify the framing. Even if the final deck doesn't carry the links, the markdown source can.

During customer follow-up. When a customer asks "what do you mean by X?" — point them to the glossary entry rather than ad-libbing.

As a writing standard. Every Flusso-internal document referencing a term covered here should align with the glossary's definition. If a term is used differently elsewhere in the codebase or docs, it's worth either updating the doc or expanding the glossary entry to cover the variant usage.

Contribution Conventions

Entry template. Each entry follows this structure:

```markdown

Term Name

Definition. One-paragraph definition that someone unfamiliar with the term can absorb in 30 seconds.

In practice. Concrete example(s) of how the term operates in real biotech operations. Include named examples (drugs, companies, deals, frameworks) where they help.

Why it matters. The economic, regulatory, or operational significance. Why does someone in a CFO / clinical-ops / BD seat care about this?

Where Flusso fits. (Optional — only if Flusso interacts with the concept.) Specific positioning of how the platform addresses or interacts with the concept.

Related: Other term · Other term in another file ```

When to add a new entry.

  • A term came up in a customer conversation that we ad-libbed and want to lock down for next time
  • A term is used in a deck but isn't obvious to a reader who isn't deep in clinical operations
  • A new partnership / regulatory development introduces vocabulary we'll be reusing

When to update an existing entry.

  • The Flusso positioning has sharpened (update "Where Flusso fits")
  • A new worked example illustrates the concept better than the existing one
  • The term's regulatory or industry context has shifted (e.g., new FDA guidance changes the framing of Project Optimus)

Cross-linking. Use relative markdown links (./other-file.md#anchor) so the glossary works in plain markdown viewers as well as in any rendered docs site.

Naming. Anchors in this glossary use lower-case kebab-case derived from the entry heading. Slashes and parentheses become hyphens or are dropped per standard markdown anchor generation. When in doubt, render the file and check the anchor URL.

Originally seeded 2026-05-14 from the Adagene prospect engagement (the "evidence packet" question that prompted this glossary). Maintained by the Flusso team.

Companion artefacts in docs/planning-artifacts/: