TransCelerate & CDISC — Digital Data Flow (DDF) Solution ShowcaseTransCelerate 与 CDISC — 数字数据流（DDF）Solution Showcase
Quarterly virtual Solution Showcase (webinar series, since Sep 2024). Centered on CDISC USDM (Unified Study Definition Model), v4. A protocol-digitalization webinar series — not a multi-track conference — mapped against AuroraPrime's authoring-to-eCTD white space.
季度性线上 Solution Showcase（webinar 系列，2024/9 起）。以 CDISC USDM（v4）为核心。一个方案数字化的 webinar 系列（非多轨大会），对照 AuroraPrime「撰写直达 eCTD」的白地带。
⭐ AlphaLife is presenting in Q4 2026 — this is prep + recon, not a 'should we join' question⭐ AlphaLife 将在 2026 Q4 演讲——这是筹备 + 侦察，不再是「要不要参加」的问题
TransCelerate (Govind Subramanian) confirmed AlphaLife as a Q4 'Quad3' presenter (30-min demo + Q&A, pending content approval; internal review + dry-run required). The Jul 30 webinar is one the team should attend + record. Team: Annie, Bowen Shi, Bogong Zhu.
TransCelerate（Govind Subramanian）已确认 AlphaLife 为 Q4「Quad3」演讲方（30 分钟 demo + Q&A，待内容审核；需内部过审 + 彩排）。7/30 那场团队应去听 + 录屏。团队：Annie、Bowen Shi、Bogong Zhu。
Showcase sessions
Showcase 场次
Since Sep 2024, quarterly
2024/9 起，季度
Standard
核心标准
CDISC-stewarded
CDISC 管家
Next webinar
下一场
2026, 9–10:30 ET
2026, 美东 9:00
Standards bodies
标准机构
CDISC · TransCelerate · ICH · FDA
CDISC · TransCelerate · ICH · FDA
What is DDF? (the 60-second version)DDF 是什么？（60 秒版）
DDF (Digital Data Flow)
TransCelerate initiative to turn the clinical protocol from a PDF into a machine-readable 'digital protocol' so study data flows automatically into downstream systems (EDC, eCOA, SAP, submissions) without manual re-entry.
TransCelerate 倡议：把临床方案从 PDF 变成机器可读的「数字方案」，让研究数据自动流入下游系统（EDC、eCOA、统计、递交），免去人工重复录入。
USDM (Unified Study Definition Model)
CDISC's structured data standard (now v4) that represents a study design as computable objects instead of prose. The heart of DDF; conformance is becoming table-stakes.
CDISC 的结构化数据标准（现 v4），把研究设计表示为可计算对象而非文字。DDF 的核心；一致性正在成为入场券。
SDR (Study Definitions Repository)
Open-source reference implementation + REST API for storing and exchanging USDM study definitions. Shows vendors how to build DDF-aligned, interoperable products.
存取 USDM 研究定义的开源参考实现 + REST API，示范厂商如何做 DDF 对齐、可互操作的产品。
ICH M11
The harmonized structured clinical-protocol template. Converging with USDM (M11 = the template, USDM = the machine-readable model); FDA runs an M11 pilot (PRISM).
统一的结构化临床方案模板。与 USDM 融合（M11 是模板，USDM 是机器可读模型）；FDA 有 M11 试点（PRISM）。
Showcase sessions & recordings — watch to learnShowcase 场次与录像 — 供团队查看学习
Every past webinar is on the TransCelerate playlist. Study these to prep our Q4 session and read the field.
每场往届 webinar 都在 TransCelerate 播放列表里。看这些来筹备我们的 Q4 场次、读懂这个圈子。
Sep 2024
Launch
Presenters: 演讲方：NNIT · EQTY / ClinLine
Series launch — clinical data modernization & EDC from protocol
系列首场——临床数据现代化与从方案生成 EDC
▶ Watch recording ↗观看录像 ↗Dec 2024
Q4 2024
Presenters: 演讲方：Risklick · Novo Nordisk (sponsor)
AI protocol optimization & risk; sponsor adoption view
AI 方案优化与风险；药企采用视角
▶ Watch recording ↗观看录像 ↗Mar 2025
Q1 2025
Presenters: 演讲方：data4knowledge · Content Rules · futurpositif
USDM as the first step to protocol content reuse & automation
USDM 作为方案内容复用与自动化的第一步
▶ Watch recording ↗观看录像 ↗Jul 2025
Q3 2025
Presenters: 演讲方：CRScube · studyOS (now Sitero)
Protocol-driven eClinical build & data oversight
方案驱动的 eClinical 搭建与数据监督
▶ Watch recording ↗观看录像 ↗Dec 2025
Q4 2025
Presenters: 演讲方：Faro Health · HumanTrue
AI protocol authoring / study design + protocol-to-ops AI
AI 方案撰写 / 研究设计 + 方案到运营的 AI
▶ Watch recording ↗观看录像 ↗Apr 2026
Q2 2026
Presenters: 演讲方：Nurocor · Oracle
AI-native digital protocol + M11-ready authoring; enterprise infra
AI 原生数字方案 + M11 就绪撰写；企业级基建
▶ Watch recording ↗观看录像 ↗Jul 30, 2026
Q3 2026
Presenters: 演讲方：Mushroom Solutions · Saama
Continuous digital data flow via USDM standardization; extending the model
通过 USDM 标准化实现持续数字数据流；扩展模型以增强互操作
Q4 2026 (~Nov)
Q4 2026 · Quad3
Presenters: 演讲方：AlphaLife Sciences (AuroraPrime) — confirmed · +1 TBA
Our session: AI-native authoring from USDM digital protocol → CSR → eCTD
我们的场次：从 USDM 数字方案 → CSR → eCTD 的 AI 原生撰写
Where AuroraPrime fits — authoring beyond the digital protocolAuroraPrime 的切入点 — 撰写延伸到数字方案之外
The showcase field clusters on the digital protocol (USDM/SoA/M11). Few carry through to CSR + eCTD. That downstream authoring stretch is our wedge.
showcase 圈子集中在数字方案（USDM/SoA/M11），很少贯通到 CSR + eCTD。那段下游撰写正是我们的切入点。
Authoring beyond design — USDM protocol → CSR → eCTD撰写延伸到设计之外——USDM 方案 → CSR → eCTD
Evidence: Showcase vendors (Nurocor, Faro, Content Rules, Risklick) cluster on study design & the digital protocol; few carry through to the regulatory submission.
证据：Showcase vendor（Nurocor、Faro、Content Rules、Risklick）集中在研究设计与数字方案；很少贯通到监管递交。
Angle: Position AuroraPrime as the layer that turns a USDM digital protocol into eCTD-ready documents.
切入点：把 AuroraPrime 定位为「把 USDM 数字方案变成 eCTD 就绪文档」的那一层。
USDM-conformant OUTPUT from an AI authorAI 撰写器输出 USDM 一致内容
Evidence: USDM is becoming table-stakes; a prose-only protocol won't plug into sponsors' digital ecosystems.
证据：USDM 正成为入场券；纯文本方案无法接入药企的数字生态。
Angle: Speak USDM natively (ingest + emit) so AuroraPrime is a vendor-of-choice for digital-first sponsors.
切入点：原生支持 USDM（读入 + 产出），成为数字优先药企的首选。
Regulatory-grade, multi-region + PV/labeling breadth监管级、多区域 + PV/labeling 广度
Evidence: Design-focused players don't cover CSR, labeling, PV, or multi-region (FDA/EMA/PMDA/NMPA) authoring.
证据：偏设计的玩家不覆盖 CSR、labeling、PV 或多区域（FDA/EMA/PMDA/NMPA）撰写。
Angle: Our breadth is the moat versus single-point digital-protocol tools.
切入点：我们的广度就是相对单点数字方案工具的护城河。
What to watch要盯什么
Now also tracked in the market-monitoring dashboard keywords.
这些信号已同步加入 market-monitoring 监控关键词。
USDM version / conformanceUSDM 版本 / 一致性规则
v4 adoption; new conformance rulesv4 采用；新一致性规则
ICH M11 Step 4 timingICH M11 Step 4 时间点
Finalization solidifies regulatory alignment定稿将夯实监管对齐
FDA PRISM / M11 pilotFDA PRISM / M11 试点
Signals regulators expecting structured protocols预示监管方期待结构化方案
Quarterly showcase presenters每季 showcase 演讲者
Watch Nurocor, Faro, Mushroom moves关注 Nurocor、Faro、Mushroom 动向
CDISC AI Innovation ChallengeCDISC AI 创新挑战赛
Winners flag emerging players获奖者预示新兴玩家
Source: TransCelerate + CDISC DDF Solution Showcase · webinar playlist; the two TransCelerate invite/confirmation emails; vendor sites (2026-07). See research/ddf-2026/.数据来源：TransCelerate + CDISC DDF Solution Showcase · webinar 播放列表；两封 TransCelerate 邀请/确认邮件；厂商官网（2026-07）。见 research/ddf-2026/。