Administration

Users and roles, taxonomy, metric definitions, integrations, audit trail, AI governance and compliance support.

Signed-in user

This sample build is signed in as Dr. Helen Okafor (Global Head of Medical Affairs). The identity is fixed to CURRENT_USER_ID; in a deployed tenant it comes from the SSO token and switching users means signing in as them.

SSO and provisioning

Identity provider: Entra ID · healthy
MFA: Enforced
Session timeout: 30 min idle
SCIM: 18 users provisioned

User	Role	Function	Country / region	Products in scope	Active	Last login
HODr. Helen OkaforGlobal Head of Medical Affairs	Medical Affairs executive	Leadership	United States · North America	VantrexaNephradaLumevaAurelin	Active	15 Sept 2026, 07:42 UTC
PRDr. Priya RamanGlobal Medical Lead, Vantrexa	Global medical lead	Leadership	United States · North America	Vantrexa	Active	15 Sept 2026, 06:10 UTC
MLDr. Marcus LindqvistGlobal Medical Lead, Nephrada	Global medical lead	Leadership	Germany · Europe	Nephrada	Active	14 Sept 2026, 16:55 UTC
EMDr. Elena MorettiGlobal Medical Lead, Lumeva	Global medical lead	Leadership	Italy · Europe	Lumeva	Active	15 Sept 2026, 08:05 UTC
TFDr. Tomás FerreiraGlobal Medical Lead, Aurelin	Global medical lead	Leadership	United States · North America	Aurelin	Active	12 Sept 2026, 13:20 UTC
SLDr. Sophie LaurentRegional Medical Lead, Europe	Regional medical lead	Leadership	France · Europe	VantrexaNephradaLumeva	Active	15 Sept 2026, 07:00 UTC
KWDr. Kenji WatanabeCountry Medical Lead, Japan	Country medical lead	Leadership	Japan · Asia-Pacific	VantrexaLumeva	Active	15 Sept 2026, 01:15 UTC
JWJames WhitfieldSenior MSL, Oncology (US East)	Field medical (MSL)	Field Medical	United States · North America	Vantrexa	Active	15 Sept 2026, 11:30 UTC
ABDr. Anna BeckerMSL, Nephrology (DACH)	Field medical (MSL)	Field Medical	Germany · Europe	Nephrada	Active	15 Sept 2026, 09:48 UTC
LOLuis OrtegaMSL, Neurology (Iberia)	Field medical (MSL)	Field Medical	Spain · Europe	Lumeva	Active	14 Sept 2026, 17:22 UTC
MTMei TanakaMSL, Oncology (Japan)	Field medical (MSL)	Field Medical	Japan · Asia-Pacific	Vantrexa	Active	15 Sept 2026, 02:05 UTC
RARachel AdeyemiMSL, Oncology (UK & Ireland)	Field medical (MSL)	Field Medical	United Kingdom · Europe	Vantrexa	Active	15 Sept 2026, 08:40 UTC
DCDavid ChenHead of Medical Communications	Medical communications	Medical Communications	United States · North America	VantrexaNephradaLumevaAurelin	Active	15 Sept 2026, 10:12 UTC
FAFatima Al-SayedMedical Information Lead	Medical information	Medical Information	United Kingdom · Europe	VantrexaNephradaLumevaAurelin	Active	15 Sept 2026, 08:00 UTC
NPDr. Nikolai PetrovHead of Evidence Generation & HEOR	Evidence generation / HEOR	Evidence Generation	Germany · Europe	VantrexaNephradaLumevaAurelin	Active	14 Sept 2026, 15:30 UTC
GNGrace NakamuraMedical Operations Lead	Medical operations	Medical Operations	United States · North America	VantrexaNephradaLumevaAurelin	Active	15 Sept 2026, 12:01 UTC
OBOliver BrandtCompliance & Quality Partner	Compliance / audit	Compliance	Germany · Europe	VantrexaNephradaLumevaAurelin	Active	13 Sept 2026, 09:10 UTC
SHSara HolmMarket Access Director	Cross-functional partner	Cross-functional	United States · North America	VantrexaNephrada	Active	11 Sept 2026, 14:45 UTC

Capability	Executive	Medical Lead	Field Medical	Medical Ops	Compliance	Cross-functional
View portfolio dashboards	Yes	Yes	Limited	Yes	Yes	Limited
Create and edit medical plans	No	Yes	No	Configurable	No	No
Approve medical plans	Yes	Review	No	No	Review	No
Record engagements	No	Limited	Own records	No	No	No
View stakeholder profiles	Limited	Yes	Territory-based	Limited	Yes	Restricted
Capture insights	No	Yes	Own records	No	No	Limited
Review, prioritise and route insights	No	Yes	No	Configurable	Review	No
View restricted-class insights	Yes	Yes	No	No	Yes	No
Manage publications and congress activities	No	Yes	No	Configurable	Review	No
Handle medical-information inquiries	No	Limited	No	No	Review	No
Override launch readiness scores	No	Yes	No	No	Review	No
View budget and actuals	Yes	Yes	No	Limited	Limited	Restricted
Export data	Yes	Limited	Own records	Configurable	Yes	Restricted
Manage metric definitions	Review	Review	No	Yes	Review	No
Configure taxonomy and workflows	No	No	No	Yes	Review	No
Manage integrations	No	No	No	Yes	No	No
View audit trail	Limited	Limited	Own records	Limited	Yes	No
Approve AI feature enablement	Review	No	No	Yes	Review	No
Manage users and roles	No	No	No	Yes	Review	No

Segregation of duties and configurability

Approval capabilities are separated from authoring: a user cannot approve a plan, decision or publication they own. Values marked Configurable or Limited are tenant settings within controlled limits (for example, Medical Ops may be granted plan editing for a launch period). Changes to the matrix are versioned and audited.

Role	Key	Description	Users
Platform administrator	platform_admin	Full tenant configuration.	0
Medical Affairs executive	ma_executive	Portfolio view, plan approval, exports.	1
Global medical lead	global_medical_lead	Owns product strategy and plans.	4
Regional medical lead	regional_medical_lead	Regional adaptation and oversight.	1
Country medical lead	country_medical_lead	Local plans and execution.	1
Field medical (MSL)	field_medical	Engagements and insight capture.	5
Medical communications	med_comms	Publications and congress deliverables.	1
Medical information	med_info	Inquiry handling and SLA monitoring.	1
Evidence generation / HEOR	evidence_gen	Research portfolio management.	1
Medical operations	med_ops	Workflows, metrics, integrations, data quality.	1
Compliance / audit	compliance	Audit trail, approvals, evidence packages.	1
Finance	finance	Budget and actuals.	0
Cross-functional partner	cross_functional	Scoped read access.	1
Read-only executive	read_only_exec	Dashboards only.	0

Products

Brand	INN	Therapeutic area	Disease areas	Lifecycle stage	Global medical lead	Launch countries
Vantrexa VTX	vantrelimab	Oncology	Non-small cell lung cancer, Small cell lung cancer	Launch	PRDr. Priya Raman	5
Nephrada NPH	nephradin	Nephrology	IgA nephropathy, Focal segmental glomerulosclerosis	Pre-launch	MLDr. Marcus Lindqvist	3
Lumeva LMV	lumevarin	Neurology	Migraine	Mature post-launch	EMDr. Elena Moretti	10
Aurelin ARL	aurelinate	Immunology	Atopic dermatitis	Late clinical development	TFDr. Tomás Ferreira	0

Therapeutic and disease areas

Oncology ONCNon-small cell lung cancer, Small cell lung cancer
Nephrology NEPHIgA nephropathy, Focal segmental glomerulosclerosis
Neurology NEUROMigraine
Immunology IMMAtopic dermatitis

Countries by region

10 countries in the tenant list

North America NAUnited States (US), Canada (CA)
Europe EUGermany (DE), United Kingdom (GB), France (FR), Spain (ES), Italy (IT)
Asia-Pacific APACJapan (JP), Australia (AU)
Latin America LATAMBrazil (BR)

Lifecycle stages

10 default stages · order fixed · labels configurable per tenant

Preclinical
Early clinical development
Late clinical development
Regulatory submission
Pre-launch
Launch
Early post-launch
Mature post-launch
Lifecycle extension
Discontinuation

Insight taxonomy

v3 · effective 2026-01-01 · local extensions controlled (regional admins may add sub-categories that roll up to these 22)

Unmet medical need
Disease burden
Diagnosis and screening
Treatment pathway
Clinical practice
Product understanding
Efficacy
Safety and tolerability
Patient experience
Adherence and persistence
Health economics
Access and reimbursement
Evidence gap
Trial design
Comparator landscape
Competitor activity
Education need
Medical-information need
Publication need
Digital or technology need
Patient-advocacy need
Regulatory or policy issue

Initiative types

13 types

Medical strategy initiative
Field medical campaign
Publication project
Congress activity
Medical education program
Advisory board
Investigator-initiated study
RWE project
HEOR project
Medical-information improvement
Launch-readiness workstream
Cross-functional evidence project
Capability-development program

Status model (work records)

Configurable within controlled limits: labels and transitions may change; terminal states and audit semantics may not

Not started
Planned
In progress
Blocked
At risk
Completed
Cancelled
On hold
Superseded

Integration	Direction	Schedule	Last sync	Records	Error queue	System of record	Owner	Status · actions
Veeva CRM — engagements & stakeholdersVeeva CRM · CRM · INT-01	Inbound	Every 4 hours	15 Sept 2026, 08:00 UTCtoday	412	14	Yes	GNGrace Nakamura	Degraded
Veeva Vault — approved contentVeeva Vault · Content · INT-02	Inbound	Daily 02:00 UTC	15 Sept 2026, 02:00 UTCtoday	86	0	Yes	DCDavid Chen	Healthy
Microsoft Entra ID — SSO & SCIMMicrosoft Entra ID · Identity · INT-03	Inbound	Real-time	15 Sept 2026, 11:58 UTCtoday	18	0	Yes	GNGrace Nakamura	Healthy
SAP — budget actualsSAP S/4HANA · Finance · INT-04	Inbound	Monthly (3rd business day)	03 Sept 2026, 02:00 UTC12 days ago	1,240	0	Yes	GNGrace Nakamura	Healthy
MI inquiry platformIRMS · Medical information · INT-05	Inbound	Hourly	15 Sept 2026, 11:00 UTCtoday	27	0	Yes	FAFatima Al-Sayed	Healthy
CTMS — study milestonesVeeva Vault CTMS · Study · INT-06	Inbound	Daily 03:00 UTC	13 Sept 2026, 03:00 UTC2 days ago	0	3	Yes	NPDr. Nikolai Petrov	Failed
ClinicalTrials.gov — competitor trialsClinicalTrials.gov API · External data · INT-07	Inbound	Weekly	12 Sept 2026, 06:00 UTC3 days ago	212	0	No	GNGrace Nakamura	Healthy
PubMed — publication metricsPubMed E-utilities · External data · INT-08	Inbound	Weekly	12 Sept 2026, 06:30 UTC3 days ago	0	0	No	DCDavid Chen	Paused

Connector capability checklist

Every connector must provide these before it is enabled in production.

Authentication (OAuth 2.0 / service principal)
Connection test
Field mapping with transformation rules
Incremental sync with watermark
Retry with back-off
Error queue with reprocessing
Deduplication on configured match keys
Record-level lineage (source id, sync time)
Reconciliation report per run
Credential revocation and rotation

Data ownership — system of record per entity

Entity	System of record	Note
Stakeholders	Veeva CRM	Hub holds a governed copy; edits flow back through the CRM
Engagements	Veeva CRM	Captured in CRM or Hub mobile capture; CRM is authoritative
Approved content	Veeva Vault	Approval status and version read-only in Hub
Budget actuals	SAP S/4HANA	Monthly extract; Hub plans and forecasts locally
Inquiries	IRMS	Hub reads status, SLA and categorisation
Study milestones	Veeva Vault CTMS	Evidence projects reference CTMS milestone ids
Plans, objectives, insights, launch scorecards	Hub	Hub is the system of record

Audit trail

Append-only and tamper-evident: each event is chained to the previous one by hash; nothing is edited or deleted, corrections are new events.

Export evidence package

Events: 176
Matching filters: 3
Electronic signatures: 1
Export scope: /api/audit?format=csv&recordId=MP-2026-VTX-G

Electronic signature events in view

Sign events record the signer, role, UTC time and the meaning of the signature (for example “Approval · Re-authenticated”). They freeze the signed version of the record.

Timestamp (UTC)	Record	Action	User	Field	Change	Reason	Source	Session · chain
13 Sept 2026, 09:45 UTC	Audit trail · MP-2026-VTX-G	Export	OBOliver BrandtCompliance / audit	—	Evidence package (PDF+CSV), 214 events	Q3 internal audit	UI	AUD-001788 sess-f3d8 · 10.13.7.5 · #9f85…
20 Jan 2026, 14:02 UTC	Medical plan · MP-2026-VTX-G	SignElectronic signature	HODr. Helen OkaforMedical Affairs executive	signature	Meaning: Approval · Re-authenticated	—	UI	AUD-000902 sess-3f9a · 10.12.4.22 · #5e66…
20 Jan 2026, 14:02 UTC	Medical plan · MP-2026-VTX-G	Approve	HODr. Helen OkaforMedical Affairs executive	status	Medical approval → Active	Approved at Q1 leadership review	UI	AUD-000901 sess-3f9a · 10.12.4.22 · #5b66…

Showing 3 of 3 matching events

Suggestions (30 days)

148

Accepted

112

Corrected

Rejected

Acceptance rate

76%

Pending review

AI feature register

Feature	Intended use	Prohibited use	Model version	Human review	Evaluation (P / R)	Last evaluated	Status
Insight summary AI-generated	Draft a neutral summary of free-text insight notes with quoted source spans	Generating scientific claims or promotional wording	helixor-private-llm-2026.08	Required	0.91 / 0.87	28 Aug 2026	Enabled
Topic classification AI-generated	Suggest an insight category from taxonomy v3	Auto-applying a category without reviewer confirmation	helixor-private-llm-2026.08	Required	0.88 / 0.84	28 Aug 2026	Enabled
Duplicate detection AI-generated	Flag likely duplicate insights and stakeholders for review	Merging or deleting records automatically	helixor-embed-v2	Required	0.94 / 0.79	15 Jul 2026	Enabled
Executive narrative AI-generated	Draft narrative paragraphs from approved metric values with citations	Distribution without named human approval; use with unapproved metrics	helixor-private-llm-2026.08	Required	0.82 / 0.80	01 Sept 2026	Enabled
Inquiry categorisation AI-generated	Suggest inquiry category and urgency for triage	Drafting or sending medical responses; safety triage decisions	helixor-private-llm-2026.08	Required	0.90 / 0.86	10 Aug 2026	Enabled

AI interaction log (7)

Timestamp	Feature	Model	Record	User	Outcome	Confidence
14 Sept 2026, 11:02 UTC	Insight summary	helixor-private-llm-2026.08	Insight · INS-0061	RARachel Adeyemi	Pending review	0.79
13 Sept 2026, 04:31 UTC	Topic classification	helixor-private-llm-2026.08	Insight · INS-0060	MTMei Tanaka	Pending review	0.88
12 Sept 2026, 09:10 UTC	Insight summary	helixor-private-llm-2026.08	Insight · INS-0047	PRDr. Priya Raman	Corrected	0.86
10 Sept 2026, 06:00 UTC	Executive narrative	helixor-private-llm-2026.08	Report · RPT-Q3-EXEC	GNGrace Nakamura	Pending review	0.74
08 Sept 2026, 09:12 UTC	Duplicate detection	helixor-embed-v2	Insight · INS-0055	FAFatima Al-Sayed	Accepted	0.94
07 Sept 2026, 14:20 UTC	Inquiry categorisation	helixor-private-llm-2026.08	Inquiry · MI-2026-0788	FAFatima Al-Sayed	Accepted	0.91
05 Sept 2026, 10:00 UTC	Topic classification	helixor-private-llm-2026.08	Insight · INS-0052	LOLuis Ortega	Rejected	0.58

Guardrails (PRD §23.3)

Every AI output is labelled as AI-generated and shows model identifier and confidence
Source spans or source records are shown next to every suggestion
Human review is required before an AI suggestion changes a record
Rejections and corrections are logged and feed model evaluation
No AI feature can approve, sign, route to Safety or send external communication
Prompts and outputs are retained for the audit period
Customer data is not used to train external models
Retrieval is tenant-isolated; no cross-tenant context
Features can be disabled per tenant and per role without release
Evaluation against a labelled sample runs before each model version is enabled

Data handling

Customer data is not used to train external models. Retrieval is tenant-isolated; prompts include only records the requesting user may read. Model versions are pinned per tenant and changed through change control.

Positioning

The product supports computerised-system validation: it ships the documentation below, an audit trail, electronic signatures and controlled configuration. Compliance itself requires the customer's validation exercise, procedures and training; the vendor does not certify a tenant as compliant.

Validation-support package

Deliverable	Status	Note
Intended-use statement template	Template	Customer completes for their process scope
Risk assessment (GAMP 5 category 4)	Available	Vendor assessment; customer adds process risks
User requirements specification (URS)	Available	Mapped to PRD sections
Functional specification (FS)	Available	Per release
Configuration specification (CS)	Template	Documents tenant configuration decisions
Traceability matrix	Available	URS → FS → test scripts
Test scripts (OQ)	Available	Executable in the validation tenant
Test evidence export	Available	Screenshots, logs and signatures per script
Release notes with impact assessment	Available	Every release
Change control procedure	Template	Aligned to customer SOP
Validation impact assessment per release	Available	Classifies changes as none / minor / major
Periodic review record	Template	Annual

ALCOA+ principles

Principle	How the system supports it
Attributable	Every change records the authenticated user, role and session; integrations run under named service identities.
Legible	Audit entries store field, previous and new value in readable form; exports render as PDF and CSV.
Contemporaneous	Server timestamps in UTC at the moment of the change; client clocks are not trusted.
Original	Source records from integrations keep the original payload id and sync time; originals are never overwritten.
Accurate	Validation rules, controlled taxonomies and data-quality monitoring; corrections keep the prior value.
Complete	Append-only trail includes creates, updates, deletes, approvals, signatures, exports and overrides.
Consistent	One event schema across modules; sequence preserved by chained hashes.
Enduring	Retention policies per record class; audit trail retained for the configured period beyond record deletion.
Available	Searchable in the UI and exportable as an evidence package on demand.

Electronic signatures (PRD §27.3)

Re-authentication (password or MFA) at the moment of signing
Signature record contains signer name, role, UTC timestamp and meaning (Approval, Review, Authorship)
Signed record version is frozen; later changes create a new version requiring re-signature
Signature events are Sign actions in the audit trail and cannot be edited or removed
Signature manifest is included in the evidence package export

Sample signature event

AUD-000902 · 20 Jan 2026, 14:02 UTC · Medical plan MP-2026-VTX-G · Meaning: Approval · Re-authenticated

Data classification

Level	Examples	Access	Export	Retention	AI processing
Public	Published articles, congress names	All roles	Unrestricted	Indefinite	Allowed
Internal	Plans, objectives, metrics	Scoped by product and geography	Logged	7 years after archive	Allowed (tenant model)
Confidential	Insights, engagement notes, budgets	Role and scope	Logged; approval for bulk export	7 years	Allowed with source-span display
Restricted	Safety-flagged insights, pseudonymised stakeholder data	Named roles only	Compliance approval; watermarked	Per PV and privacy policy	Summarisation only; no classification
Commercially sensitive	Pre-approval launch dates, pricing context	Executive and named leads	Blocked by default	Until public then Internal	Not processed

Privacy controls (PRD §27.6)

Data minimisation: stakeholder records hold professional data only; personal identifiers pseudonymised where consent is pending
Consent status is recorded per stakeholder and enforced on engagement capture
Purpose limitation: insights are scientific exchange records, not commercial targeting
Access is scoped by role, product and territory; every access to Restricted data is logged
Data-subject requests (access, rectification, erasure) are handled through a tracked workflow
Retention schedules are applied per record class with legal hold support
Sub-processors and hosting regions are documented; EU data stays in EU regions
Encryption in transit (TLS 1.2+) and at rest; keys managed per tenant

Safety handling (PRD §27.7)

Any engagement, insight or inquiry with a safety flag creates a Safety hand-off task within the reporting timeline
Pharmacovigilance intake is the system of record for adverse events; the Hub stores only the reference and status
Safety-flagged records are Restricted class and excluded from AI classification
Medical-information responses on safety topics require Medical review before sending
Safety hand-offs appear on the compliance dashboard until PV confirms receipt

User

Role

Function

Country / region

Products in scope

Active

Last login

HODr. Helen OkaforGlobal Head of Medical Affairs

Medical Affairs executive

Leadership

United States · North America

VantrexaNephradaLumevaAurelin

Active

15 Sept 2026, 07:42 UTC

PRDr. Priya RamanGlobal Medical Lead, Vantrexa

Global medical lead

Leadership

United States · North America

Vantrexa

Active

15 Sept 2026, 06:10 UTC

MLDr. Marcus LindqvistGlobal Medical Lead, Nephrada

Global medical lead

Leadership

Germany · Europe

Nephrada

Active

14 Sept 2026, 16:55 UTC

EMDr. Elena MorettiGlobal Medical Lead, Lumeva

Global medical lead

Leadership

Italy · Europe

Lumeva

Active

15 Sept 2026, 08:05 UTC

TFDr. Tomás FerreiraGlobal Medical Lead, Aurelin

Global medical lead

Leadership

United States · North America

Aurelin

Active

12 Sept 2026, 13:20 UTC

SLDr. Sophie LaurentRegional Medical Lead, Europe

Regional medical lead

Leadership

France · Europe

VantrexaNephradaLumeva

Active

15 Sept 2026, 07:00 UTC

KWDr. Kenji WatanabeCountry Medical Lead, Japan

Country medical lead

Leadership

Japan · Asia-Pacific

VantrexaLumeva

Active

15 Sept 2026, 01:15 UTC

JWJames WhitfieldSenior MSL, Oncology (US East)

Field medical (MSL)

Field Medical

United States · North America

Vantrexa

Active

15 Sept 2026, 11:30 UTC

ABDr. Anna BeckerMSL, Nephrology (DACH)

Field medical (MSL)

Field Medical

Germany · Europe

Nephrada

Active

15 Sept 2026, 09:48 UTC

LOLuis OrtegaMSL, Neurology (Iberia)

Field medical (MSL)

Field Medical

Spain · Europe

Lumeva

Active

14 Sept 2026, 17:22 UTC

MTMei TanakaMSL, Oncology (Japan)

Field medical (MSL)

Field Medical

Japan · Asia-Pacific

Vantrexa

Active

15 Sept 2026, 02:05 UTC

RARachel AdeyemiMSL, Oncology (UK & Ireland)

Field medical (MSL)

Field Medical

United Kingdom · Europe

Vantrexa

Active

15 Sept 2026, 08:40 UTC

DCDavid ChenHead of Medical Communications

Medical communications

Medical Communications

United States · North America

VantrexaNephradaLumevaAurelin

Active

15 Sept 2026, 10:12 UTC

FAFatima Al-SayedMedical Information Lead

Medical information

Medical Information

United Kingdom · Europe

VantrexaNephradaLumevaAurelin

Active

15 Sept 2026, 08:00 UTC

NPDr. Nikolai PetrovHead of Evidence Generation & HEOR

Evidence generation / HEOR

Evidence Generation

Germany · Europe

VantrexaNephradaLumevaAurelin

Active

14 Sept 2026, 15:30 UTC

GNGrace NakamuraMedical Operations Lead

Medical operations

Medical Operations

United States · North America

VantrexaNephradaLumevaAurelin

Active

15 Sept 2026, 12:01 UTC

OBOliver BrandtCompliance & Quality Partner

Compliance / audit

Compliance

Germany · Europe

VantrexaNephradaLumevaAurelin

Active

13 Sept 2026, 09:10 UTC

SHSara HolmMarket Access Director

Cross-functional partner

Cross-functional

United States · North America

VantrexaNephrada

Active

11 Sept 2026, 14:45 UTC

Capability

Executive

Medical Lead

Field Medical

Medical Ops

Compliance

Cross-functional

View portfolio dashboards

Yes

Limited

Yes

Limited

Create and edit medical plans

Yes

Configurable

Approve medical plans

Yes

Review

Record engagements

Limited

Own records

View stakeholder profiles

Limited

Yes

Territory-based

Limited

Yes

Restricted

Capture insights

Yes

Own records

Limited

Review, prioritise and route insights

Yes

Configurable

Review

View restricted-class insights

Yes

Manage publications and congress activities

Yes

Configurable

Review

Handle medical-information inquiries

Limited

Review

Override launch readiness scores

Yes

Review

View budget and actuals

Yes

Limited

Restricted

Export data

Yes

Limited

Own records

Configurable

Yes

Restricted

Manage metric definitions

Review

Yes

Review

Configure taxonomy and workflows

Yes

Review

Manage integrations

Yes

View audit trail

Limited

Own records

Limited

Yes

Approve AI feature enablement

Review

Yes

Review

Manage users and roles

Yes

Review

Role

Key

Description

Users

Platform administrator

platform_admin

Full tenant configuration.

Medical Affairs executive

ma_executive

Portfolio view, plan approval, exports.

Global medical lead

global_medical_lead

Owns product strategy and plans.

Regional medical lead

regional_medical_lead

Regional adaptation and oversight.

Country medical lead

country_medical_lead

Local plans and execution.

Field medical (MSL)

field_medical

Engagements and insight capture.

Medical communications

med_comms

Publications and congress deliverables.

Medical information

med_info

Inquiry handling and SLA monitoring.

Evidence generation / HEOR

evidence_gen

Research portfolio management.

Medical operations

med_ops

Workflows, metrics, integrations, data quality.

Compliance / audit

compliance

Audit trail, approvals, evidence packages.

Finance

finance

Budget and actuals.

Cross-functional partner

cross_functional

Scoped read access.

Read-only executive

read_only_exec

Dashboards only.

Brand

INN

Therapeutic area

Disease areas

Lifecycle stage

Global medical lead

Launch countries

Vantrexa VTX

vantrelimab

Oncology

Non-small cell lung cancer, Small cell lung cancer

Launch

PRDr. Priya Raman

Nephrada NPH

nephradin

Nephrology

IgA nephropathy, Focal segmental glomerulosclerosis

Pre-launch

MLDr. Marcus Lindqvist

Lumeva LMV

lumevarin

Neurology

Migraine

Mature post-launch

EMDr. Elena Moretti

Aurelin ARL

aurelinate

Immunology

Atopic dermatitis

Late clinical development

TFDr. Tomás Ferreira

Integration

Direction

Schedule

Last sync

Records

Error queue

System of record

Owner

Status · actions

Veeva CRM — engagements & stakeholdersVeeva CRM · CRM · INT-01

Inbound

Every 4 hours

15 Sept 2026, 08:00 UTCtoday

412

Yes

GNGrace Nakamura

Degraded

Veeva Vault — approved contentVeeva Vault · Content · INT-02

Inbound

Daily 02:00 UTC

15 Sept 2026, 02:00 UTCtoday

Yes

DCDavid Chen

Healthy

Microsoft Entra ID — SSO & SCIMMicrosoft Entra ID · Identity · INT-03

Inbound

Real-time

15 Sept 2026, 11:58 UTCtoday

Yes

GNGrace Nakamura

Healthy

SAP — budget actualsSAP S/4HANA · Finance · INT-04

Inbound

Monthly (3rd business day)

03 Sept 2026, 02:00 UTC12 days ago

1,240

Yes

GNGrace Nakamura

Healthy

MI inquiry platformIRMS · Medical information · INT-05

Inbound

Hourly

15 Sept 2026, 11:00 UTCtoday

Yes

FAFatima Al-Sayed

Healthy

CTMS — study milestonesVeeva Vault CTMS · Study · INT-06

Inbound

Daily 03:00 UTC

13 Sept 2026, 03:00 UTC2 days ago

Yes

NPDr. Nikolai Petrov

Failed

ClinicalTrials.gov — competitor trialsClinicalTrials.gov API · External data · INT-07

Inbound

Weekly

12 Sept 2026, 06:00 UTC3 days ago

212

GNGrace Nakamura

Healthy

PubMed — publication metricsPubMed E-utilities · External data · INT-08

Inbound

Weekly

12 Sept 2026, 06:30 UTC3 days ago

DCDavid Chen

Paused

Entity

System of record

Note

Stakeholders

Veeva CRM

Hub holds a governed copy; edits flow back through the CRM

Engagements

Veeva CRM

Captured in CRM or Hub mobile capture; CRM is authoritative

Approved content

Veeva Vault

Approval status and version read-only in Hub

Budget actuals

SAP S/4HANA

Monthly extract; Hub plans and forecasts locally

Inquiries

IRMS

Hub reads status, SLA and categorisation

Study milestones

Veeva Vault CTMS

Evidence projects reference CTMS milestone ids

Plans, objectives, insights, launch scorecards

Hub

Hub is the system of record

Timestamp (UTC)

Record

Action

User

Field

Change

Reason

Source

Session · chain

13 Sept 2026, 09:45 UTC

Audit trail · MP-2026-VTX-G

Export

OBOliver BrandtCompliance / audit

—

Evidence package (PDF+CSV), 214 events

Q3 internal audit

AUD-001788
sess-f3d8 · 10.13.7.5 · #9f85…

20 Jan 2026, 14:02 UTC

Medical plan · MP-2026-VTX-G

SignElectronic signature

HODr. Helen OkaforMedical Affairs executive

signature

Meaning: Approval · Re-authenticated

—

AUD-000902
sess-3f9a · 10.12.4.22 · #5e66…

20 Jan 2026, 14:02 UTC

Medical plan · MP-2026-VTX-G

Approve

HODr. Helen OkaforMedical Affairs executive

status

Medical approval → Active

Approved at Q1 leadership review

AUD-000901
sess-3f9a · 10.12.4.22 · #5b66…

Feature

Intended use

Prohibited use

Model version

Human review

Evaluation (P / R)

Last evaluated

Status

Insight summary AI-generated

Draft a neutral summary of free-text insight notes with quoted source spans

Generating scientific claims or promotional wording

helixor-private-llm-2026.08

Required

0.91 / 0.87

28 Aug 2026

Enabled

Topic classification AI-generated

Suggest an insight category from taxonomy v3

Auto-applying a category without reviewer confirmation

helixor-private-llm-2026.08

Required

0.88 / 0.84

28 Aug 2026

Enabled

Duplicate detection AI-generated

Flag likely duplicate insights and stakeholders for review

Merging or deleting records automatically

helixor-embed-v2

Required

0.94 / 0.79

15 Jul 2026

Enabled

Executive narrative AI-generated

Draft narrative paragraphs from approved metric values with citations

Distribution without named human approval; use with unapproved metrics

helixor-private-llm-2026.08

Required

0.82 / 0.80

01 Sept 2026

Enabled

Inquiry categorisation AI-generated

Suggest inquiry category and urgency for triage

Drafting or sending medical responses; safety triage decisions

helixor-private-llm-2026.08

Required

0.90 / 0.86

10 Aug 2026

Enabled

Timestamp

Feature

Model

Record

User

Outcome

Confidence

14 Sept 2026, 11:02 UTC

Insight summary

helixor-private-llm-2026.08

Insight · INS-0061

RARachel Adeyemi

Pending review

0.79

13 Sept 2026, 04:31 UTC

Topic classification

helixor-private-llm-2026.08

Insight · INS-0060

MTMei Tanaka

Pending review

0.88

12 Sept 2026, 09:10 UTC

Insight summary

helixor-private-llm-2026.08

Insight · INS-0047

PRDr. Priya Raman

Corrected

0.86

10 Sept 2026, 06:00 UTC

Executive narrative

helixor-private-llm-2026.08

Report · RPT-Q3-EXEC

GNGrace Nakamura

Pending review

0.74

08 Sept 2026, 09:12 UTC

Duplicate detection

helixor-embed-v2

Insight · INS-0055

FAFatima Al-Sayed

Accepted

0.94

07 Sept 2026, 14:20 UTC

Inquiry categorisation

helixor-private-llm-2026.08

Inquiry · MI-2026-0788

FAFatima Al-Sayed

Accepted

0.91

05 Sept 2026, 10:00 UTC

Topic classification

helixor-private-llm-2026.08

Insight · INS-0052

LOLuis Ortega

Rejected

0.58

Deliverable

Status

Note

Intended-use statement template

Template

Customer completes for their process scope

Risk assessment (GAMP 5 category 4)

Available

Vendor assessment; customer adds process risks

User requirements specification (URS)

Available

Mapped to PRD sections

Functional specification (FS)

Available

Per release

Configuration specification (CS)

Template

Documents tenant configuration decisions

Traceability matrix

Available

URS → FS → test scripts

Test scripts (OQ)

Available

Executable in the validation tenant

Test evidence export

Available

Screenshots, logs and signatures per script

Release notes with impact assessment

Available

Every release

Change control procedure

Template

Aligned to customer SOP

Validation impact assessment per release

Available

Classifies changes as none / minor / major

Periodic review record

Template

Annual

Principle

How the system supports it

Attributable

Every change records the authenticated user, role and session; integrations run under named service identities.

Legible

Audit entries store field, previous and new value in readable form; exports render as PDF and CSV.

Contemporaneous

Server timestamps in UTC at the moment of the change; client clocks are not trusted.

Original

Source records from integrations keep the original payload id and sync time; originals are never overwritten.

Accurate

Validation rules, controlled taxonomies and data-quality monitoring; corrections keep the prior value.

Complete

Append-only trail includes creates, updates, deletes, approvals, signatures, exports and overrides.

Consistent

One event schema across modules; sequence preserved by chained hashes.

Enduring

Retention policies per record class; audit trail retained for the configured period beyond record deletion.

Available

Searchable in the UI and exportable as an evidence package on demand.

Level

Examples

Access

Export

Retention

AI processing

Public

Published articles, congress names

All roles

Unrestricted

Indefinite

Allowed

Internal

Plans, objectives, metrics

Scoped by product and geography

Logged

7 years after archive

Allowed (tenant model)

Confidential

Insights, engagement notes, budgets

Role and scope

Logged; approval for bulk export

7 years

Allowed with source-span display

Restricted

Safety-flagged insights, pseudonymised stakeholder data

Named roles only

Compliance approval; watermarked

Per PV and privacy policy

Summarisation only; no classification

Commercially sensitive

Pre-approval launch dates, pricing context

Executive and named leads

Blocked by default

Until public then Internal

Not processed