Executive Summary
Week of July 6, 2026
SDTM de-scoped effective Jul 6 — team rolled off; 4 use-cases remain active. MW (ICF) at risk: Amendments and Country ICF delayed to next phase; only QM releasing Jul 6. Site ICF scope still to be agreed. CRA, BioA, and CLS on track.
Use-Cases
Requirements — AI report generation workstream re-added to scope (Jun 2026); two parallel workstreams now active: Snowflake Query Rebuild and AI Report Generation. Requirements gathering in progress over next two weeks (Snowflake report generation + agentic report writing); build targeted for August, Go/No-Go Aug 31. API readiness risk mitigated for R1 via SharePoint data consolidation. RPA data availability and Jung report section review remain watch items. Matt Creason as PO; Yash S. as Application Manager (interim).
Build 10% — At Risk. Sprint 3 in active testing and validation; Tier 1 Study 10 surfaced business-rule and source-data discrepancies driving SME engagement; source precedence guidance received from Kelsie/Mary. Sprint 4 grooming complete. Release 1 targeted late September pending protocol digitization decision. Watch items: (1) Connexion API build 3 weeks behind plan — Accenture taking over; (2) ground truth datasets require sponsor review before usable as baselines; (3) protocol digitization path undecided, Panikos evaluation blocked pending additional USDM samples.
Build 40%, testing 100% — June Sprint complete: 10/11 stories done, 1 pending Connexion/Labs data (in R1 by exception). Sprint Demo Jul 1 complete; full AC review Jul 8 complete. Nova migration complete — front-end and back-end pods deployed, E2E testing done. Validation Demo with Michelle Towers scheduled Jul 9. CREQ: MVP in progress. Connexion/Lab Queries and Snowflake table descriptions remain watch items.
Build 10% — Delayed. Delivery target revised Jun 30 → Aug 15; progress % reset against new Q3 scope. QM, ICF drafting improvements, and Amendments (partial) deployed to PROD along with RBAC. RBAC risk resolved — Databricks, Azure, and ICF assistant syncing complete. Aug 15 release scope under negotiation, especially Site ICF. CREQ 95% (1 doc pending).
De-scoped effective Jul 6, 2026 — team rolled off. Historical data only. Sprint 1 had been active with OpenAI/GitHub projects created, Nova request complete, and Snowflake request submitted.
Enterprise Architecture
CRA development environment fully operational as of June 9 — Nova infrastructure provisioned, CRA team actively building on the platform.
Infrastructure provisioning for higher environments (QA, Prod) and remaining pods is in progress. Nova is a new platform for external vendor onboarding; the provisioning path is now understood and subsequent environments are expected to move significantly faster.
AWS services activation, CIS account provisioning, and environment architecture decisions (cluster count, IQ/OQ/PQ environment mapping) are being resolved in parallel — owners identified and SLAs established.
North Star Architecture Point of View in development across all AI Studio pods, integrating with the Nova platform initiative.
Value Enablement & Change Management
ICF and CRA value framework inputs being gathered — ICF working session scheduled early next week to finalize dashboard approach and pressure-test measurement methodology.
CRA value measurement pending business alignment on priorities and ownership — next steps to be defined once alignment is secured.
Finance alignment in progress with Leah — coordinating Accenture value framework with TF's preferred approach; feedback expected over coming weeks.
Follow-up with Jason planned in ~2 weeks to align on value objectives, measurement expectations, and program priorities.
North Star Environment Stand-up
| Phase | Scope | Status |
|---|---|---|
| Phase 1 — AWS Foundation | Account creation, VPC/DNS, EKS cluster, Accenture access, managed services (RDS, S3, OpenSearch) | Complete |
| Phase 2 — Agent Factory Core | Hello World POC done; CI/CD, AgentSDK + MCP scaffolding, Eval pipeline, Non-Dev environment provisioning in progress | In Progress |
| Phase 3 — Build, Wire & Migrate | Data migration, connector expansion, CREQ/GxP (in progress), eval harness, testing — pre code-freeze | In Progress |
| Phase 4 — Validation & Go-Live | Code freeze (CRA Jul 30, MW Aug 15), IQ/OQ/PQ in Validation env, CSVC, Prod deploy, canary, Go-Live | Upcoming |
Full plan in AI SDLC Playbook → North Star Migration Plan
Governing methodology applied across all AI Studio use-cases — from intake to production.
Intake & Mobilization
- Use-case intake & prioritization
- Team setup & access
- PMO & governance model
- System integration strategy
Discovery & North Star
- Current-state business process & system mapping
- Future-state vision & North Star architecture
- MVP scope confirmation
- Implementation roadmap & success criteria
POC
if applicable
- Technical feasibility validation
- Model / platform evaluation
- Data access & pipeline readiness
- Go / no-go with business sign-off
SDLC Build & Acceleration
2-week cycles
- Backlog & HLD creation
- Integration architecture
- Continuous integration
Business Acceptance
- Performance testing
- User acceptance testing (UAT)
- Business sign-off
- Defect resolution
Deployment
- Training strategy & delivery
- Train the Trainer / end users
- Cutover plan
- Final data migration
- Go-live preparation
Hypercare
- Post go-live support
- Issue resolution
- System stabilization
- Handover to Ops
Cross-cutting throughout all phases
Integrated Program Management
·Governance, milestone tracking & stakeholder reporting across all pods
Change Management & Training
·Business buy-in, SOP updates, train-the-trainer, and operational adoption
Value Realization
·KPI definition, measurement cadence, and benefits tracking against business case
CRA
CRA Assistant
Findings & Deviations Dashboard Fragmentation
CRAs navigate multiple CTMS dashboards (Siebel, Veeva Vault), manually export and prioritize data, and document in inconsistent free-text fields with limited self-QC.
Our Solution
Single prioritized site-level view of findings/deviations with structured drafting support, templated language, and completeness checks — keeping the CRA in control.
Target Outcomes
- Single prioritized view
- Eliminate manual exports
- Standardize documentation quality
Thermo Fisher Owners
BioA
AI Augmented Report Writing
Time-Intensive Manual Study Report Compilation
Manual, time-intensive compilation of study reports for regulatory delivery, with ~6-week SAR draft cycles, inconsistent formatting, and limited automation support.
Our Solution
AI-accelerated report generation for faster, GxP-compliant regulatory deliverables — targeting a reduction from ~6 weeks to ≤2 weeks draft cycle time.
Target Outcomes
- Reduce SAR cycle time to ≤2 weeks
- GxP-compliant AI drafting
- Consistent report quality
Thermo Fisher Owners
CLS
Connexion Lab Spec Automation
Manual Protocol-to-Lab Spec Translation
Manual, error-prone transformation of protocol schedules into Connexion lab spec documents. Connexion LIMS is owned by a separate group (not CRG IT), making full-scale direct LIMS automation a longer-term effort requiring broader coordination.
Our Solution
Interim: AI-assisted generation of CLS documents for Connexion load, eliminating manual effort in study startup. Long-term: direct protocol-to-LIMS data load, bypassing the CLS document step entirely — pending cross-group alignment.
Target Outcomes
- Interim: automate CLS doc creation
- Reduce manual study startup effort
- Long-term: direct protocol-to-LIMS load
Thermo Fisher Owners
MW
Medical Writing
Master to Country to Site Workflow Automation
Manual Master-Country-Site workflow with 100-200 queries per document, ~50% workload from amendments/re-consent, and version control via email/SharePoint.
Our Solution
AI-assisted document routing, automated version control and comparisons, systematic regulatory feedback capture, and RegView integration.
Target Outcomes
- Reduce document cycle time
- Automate version control
- Capture regulatory learnings
Thermo Fisher Owners
SDTM
Study Data Tabulation Model
Manual SDTM Specification Generation & Mapping
Manual, time-intensive creation of SDTM specifications, source-to-target data mapping, and inconsistency detection with limited standardization and reuse across study types.
Our Solution
Automated workflow for SDTM spec generation (General Tab), source-to-target mapping, inconsistency detection, and human-in-the-loop validation — GxP-appropriate, CDISC-compliant.
Target Outcomes
- Faster spec generation & mapping
- Standardized naming & alignment (CDISC)
- Reusable across study types
Thermo Fisher Owners
Tech Sprint Daily
CRA10:00–10:30 AM ET
TF: Digital Product Owner, Technical Lead, Program Lead
ACN: Technical Lead, Dev Team, QA Lead
Opt: ACN Pod Lead, UX Lead, Delivery Lead
Tech Sprint Planning
CRA10:00–11:30 AM ET
Biweekly
TF: Digital Product Owner, Technical Lead, Program Lead
ACN: Technical Lead, Dev Team, QA Lead
Opt: ACN Pod Lead, UX Lead, Delivery Lead
Requirements Gathering
MW9:00–10:00 PM IST
TF: Maria, Yuri, Abhishek
ACN: Ana, Rituparna, Parth
Opt: Lax
Sprint Planning
MWEvery two weeks
Biweekly
ACN: Dev Team
Tech Sprint Daily
CRA10:00–10:30 AM ET
TF: Digital Product Owner, Technical Lead, Program Lead
ACN: Technical Lead, Dev Team, QA Lead
Opt: ACN Pod Lead, UX Lead, Delivery Lead
Architecture Focus Session
CRA10:30–11:30 AM ET
Weekly
TF: Technical Lead, Digital Product Owner, Program Lead, Business Owner
ACN: Solution Architect, Technical Lead, Delivery Lead, Pod Lead
Opt: ACN QA Lead, OpenAI: Mary Sha
Requirements Gathering
MW9:00–10:00 PM IST
TF: Maria, Yuri, Abhishek
ACN: Ana, Rituparna, Parth
Opt: Lax
Tech Sprint Daily
CRA10:00–10:30 AM ET
TF: Digital Product Owner, Technical Lead, Program Lead
ACN: Technical Lead, Dev Team, QA Lead
Opt: ACN Pod Lead, UX Lead, Delivery Lead
UI/UX Focus Session
CRA10:30–11:30 AM ET
Weekly
TF: Business Owner, CRA SME Lead, Program Lead, UX Lead
ACN: UX/UI Lead, Technical Lead, QA Lead, Pod Lead
Requirements Gathering
MW9:00–10:00 PM IST
TF: Maria, Yuri, Abhishek
ACN: Ana, Rituparna, Parth
Opt: Lax
Tech Sprint Daily
CRA10:00–10:30 AM ET
TF: Digital Product Owner, Technical Lead, Program Lead
ACN: Technical Lead, Dev Team, QA Lead
Opt: ACN Pod Lead, UX Lead, Delivery Lead
Sprint Grooming Session
CRA10:30–11:30 AM ET
Biweekly
TF: Digital Product Owner, Product Manager
ACN: Technical Lead, Dev Team, Pod Lead
Business/Functional Focus
CRA2:00–3:00 PM ET
Weekly
TF: Business Owner, CRA SME, Program Lead
ACN: Delivery Lead, Pod Lead, QA Lead
Opt: Functional Consultant, Technical Lead, OpenAI: Emily Capstick
Requirements Gathering
MW9:00–10:00 PM IST
TF: Maria, Yuri, Abhishek
ACN: Ana, Rituparna, Parth
Opt: Lax
AI Studio Program Governance
Prog.9:00–10:00 AM ET
Weekly
TF: AI Studio Leadership, Business Owners, Product Owners
ACN: Accenture Delivery Leads
Tech Sprint Daily
CRA10:00–10:30 AM ET
TF: Digital Product Owner, Technical Lead, Program Lead
ACN: Technical Lead, Dev Team, QA Lead
Opt: ACN Pod Lead, UX Lead, Delivery Lead
Tech Sprint Review
CRA10:00–11:30 AM ET
Biweekly
TF: Digital Product Owner, Technical Lead, Program Lead
ACN: Technical Lead, Dev Team, QA Lead
Opt: ACN Pod Lead, UX Lead, Delivery Lead
Sprint Review
MWEvery two weeks
Biweekly
ACN: Dev Team
Times shown as ET unless noted IST. Biweekly meetings occur every other occurrence on the listed day. CRA meetings follow the sprint cadence; ICF meetings follow the sprint weekly calendar.
AI Studio North Star Architecture Playbook
Accenture × Thermo Fisher target architecture POV
Program SharePoint
Agent Factory shared documents & project files
Program Charter
MVP use cases, scope & success criteria
Weekly Status Decks
ASD, CRA, MW status reports