Executive Home

Good morning, Antonio.

Curated intelligence for portfolio-level decisions. Reviewed by AI, ready for your judgment.

Active Studies

47

▲ 2 vs. last week

Countries Active

62

◆ 0 vs. last week

Patients Enrolled

4,318

▲ 84 last 7d

Portfolio Health

82%

▼ 3 vs. last week

Milestone Confidence

76%

▼ 4 vs. last week

Budget Health

91%

◆ 0 vs. last week

High-Risk Studies

4

▲ 1 vs. last week

AI Insights Today

12

3 unread

Morning Briefing

Generated 07:58 CET · Reading time ~2 min

Executive Briefing — 01 July 2026

08:00 CET

Portfolio health closed the week at 82%, down three points on softer enrollment velocity in Haematology. Four items require your attention today; two are time-critical.

HEM-302 — enrollment risk increasing after three site closures in Germany and France. Impact +21d LPI. Critical
ONC-118 — Germany activation delayed by CTIS query response cycle. Impact +12d FSI. Elevated
Vendor Alpha CRO — monitoring quality trending down across three studies (KRI-04, KRI-11). Elevated
ONC-214 — submission readiness on track for EMA MAA in Q3. All Module 5 sections green. On track

Estimated portfolio impact if unmitigated

+18 days

Cumulative slippage across 3 studies over the next 6 weeks.

AI Recommendations

Reallocate enrollment effort to Spain and Poland for HEM-302. CONF91%
Escalate Vendor Alpha QBR this week; request corrective action plan on monitoring visits. CONF87%
Approve contingency activation of Belgium for HEM-302 to protect LPI. CONF78%

Critical Decisions Required Today

3 awaiting decision

HEM-302 · Phase III · Haematology Awaiting decision

Enrollment Risk — Activate Contingency

Impact

+21 days to LPI · Estimated additional cost USD 1.8M

Evidence

Enrollment velocity decreased 18% over the last 4 weeks
Three high-performing sites closed in Germany and France
Competing trial NCT-EX-441 opened in the same indication

AI Recommendation

Recommended actions

Activate Belgium (5 pre-qualified sites, ~9 days to first patient)
Increase Spain recruitment target from 42 to 58 patients
Deploy two additional CRAs to top-tier Polish sites

Confidence 88% Based on historical activation performance in Belgium (median 11 days), Spanish investigator productivity index (top decile), and current CRA workload distribution. 5 supporting operational signals.

Vendor Alpha CRO · 3 studies affected Awaiting decision

Vendor Performance — Escalation QBR

Impact

Quality KRI −22% · Risk of inspection findings on ONC-118, HEM-302, IMU-041

Evidence

Monitoring visit completion rate 71% (target 90%)
Overdue queries 218 (up from 96 four weeks ago)
3 CAPA items opened in the last 30 days across studies

AI Recommendation

Recommended actions

Schedule executive QBR with Vendor Alpha within 5 business days
Request written corrective action plan (14-day turnaround)
Reallocate ONC-118 monitoring scope to Vendor Beta as interim

Confidence 87% Based on 3-month KRI trend, comparable vendor benchmarks, and contract SLA thresholds. 4 supporting operational signals.

ONC-118 · Phase II · Oncology Awaiting decision

Regulatory Query — Fast-Track Response

Impact

+12 days FSI Germany · Blocks 8 planned sites

Evidence

BfArM Q&A on secondary endpoint definition (received D-5)
Response window closes in 9 business days per CTIS timeline
Similar precedent resolved in 6 days on ONC-097 (2025)

AI Recommendation

Recommended actions

Convene Medical Writing + Biostats + Reg Affairs within 24 hours
Reuse ONC-097 response template as starting point
Target submission at D+5 to hold Germany activation on plan

Confidence 82% Based on precedent response time, template applicability match, and current team capacity. 3 supporting operational signals.

Portfolio · Cross-cutting Awaiting decision

CRA Workforce — Reallocation for Q3

Impact

Utilization 108% · Burnout risk on 4 senior CRAs in DACH

Evidence

Overtime hours up 34% over prior quarter
2 resignations in last 60 days, 3 open requisitions unfilled
Iberia CRA pool at 78% utilization with available capacity

AI Recommendation

Recommended actions

Reassign 2 CRAs from Iberia to DACH monitoring pool for Q3
Fast-track hiring for 2 Junior CRA roles in Germany
Approve remote monitoring pilot for low-risk sites

Confidence 74% Based on utilization dashboards, historical attrition patterns, and site risk stratification. 6 supporting operational signals.

Portfolio Intelligence

Portfolio Overview

47 active studies across Oncology, Haematology and Immunology. Health scores blend enrollment, quality, timeline confidence and budget signals.

Study Workspace

Studies

Operational depth by study. Click a row to open the study workspace.

Study	Phase	TA	Sites	Enrollment	Timeline Conf.	Health	Risk

Risk Intelligence

Portfolio Risk Heatmap

Scores are RBQM-weighted. Trend shows 4-week direction. Click a cell to open the root-cause panel.

Risk Category

ONC-118

ONC-214

HEM-302

HEM-405

IMU-041

RAR-007

Enrollment

3.2▲

1.4▼

4.6▲

2.1◆

3.0◆

2.4▼

Vendor

4.1▲

2.0◆

4.0▲

1.6▼

3.3▲

2.1◆

Quality

3.4▲

1.5◆

3.6▲

2.4◆

2.7▼

2.0◆

Budget

2.6◆

1.4▼

3.1▲

2.0◆

2.2◆

1.7▼

Inspection Readiness

3.1▲

1.2▼

4.2▲

2.3◆

2.5◆

1.9◆

Protocol

2.3◆

1.5◆

3.4▲

2.6▲

2.4◆

2.0◆

Timeline

4.0▲

1.6▼

4.7▲

2.5◆

3.0◆

2.2◆

Portfolio Timeline

Milestone Confidence · Next 12 Months

Diamonds mark milestones. Bars show progression. Amber bars indicate AI-detected slippage risk.

Jul

Aug

Sep

Oct

Nov

Dec

Q1'27

Q2'27

Enrollment (LPI)HEM-302

Database LockONC-118

CSR DeliveryONC-214

EMA MAA SubmissionONC-214

FSIHEM-405

Protocol FinalizationIMU-041

Interim AnalysisRAR-007

Scenario Planning

Test decisions before you make them

Model operational changes on HEM-302. Impact estimates are AI-generated using synthetic historical benchmarks.

Study · HEM-302 · Phase III · Haematology

Increase Spain enrollment target +20%

Deploy additional CRAs 2

Site activation acceleration 10%

Activate Belgium5 pre-qualified sites

Replace Vendor Alpha6-week transition

Simplify protocol (Amendment 3)Reduces exclusion criteria

Enable remote monitoringLow-risk sites only

Projected Impact

Relative to baseline plan · 90-day horizon

Timeline (LPI)

−14 d

vs baseline +21d slippage

Budget

+USD 620K

One-off activation + CRA cost

Risk Reduction

−1.4

Enrollment risk score

Enrollment Uplift

+18%

Rate over next 60 days

Confidence 79% Based on Belgium historical activation median (11d), Spanish investigator productivity index (top decile), CRA marginal contribution curve, and 12 comparable trial precedents. Not a commitment; validate with Country Heads before execution.

AI Executive Copilot

Ask the portfolio

A strategic assistant. Not a chatbot. Every answer cites the operational signals behind it.

Copilot

Good morning, Antonio. I have reviewed 47 studies, 218 open queries and today's operational signals. Ask anything, or pick a suggested prompt on the left.

Governance

Decision History

Every executive decision recorded with the AI recommendation, the human approver, and the actual outcome vs prediction.

Date

Decision

AI Recommendation

Approver

Outcome

Variance

2026-06-24

ONC-118 · Reallocate 3 sites Poland → Spain

Reallocate 3–4 sites

A. Martínez

−8 d FSI

+2 d better

2026-06-18

HEM-405 · Approve Amendment 2 (endpoint clarification)

Approve as drafted

A. Martínez

Approved

On plan

2026-06-11

IMU-041 · Delay activation US until CTA response

Proceed with activation

A. Martínez Override

+5 d FSI

−3 d worse

2026-06-04

ONC-214 · Fast-track medical writing team

Approve fast-track

A. Martínez

CSR ready −6 d

+4 d better

2026-05-28

Vendor Beta · Extend contract 6 months

Extend 6 months

A. Martínez

Signed

On plan

Future Modules

Roadmap

Clinical Development Command CenterAvailable

TrialIntelAvailable

PharmaOptimaAvailable

Protocol IntelligenceComing soon

Feasibility IntelligenceComing soon

Enrollment IntelligenceComing soon

Vendor IntelligenceComing soon

CRA Workforce PlannerComing soon

Medical Writing AssistantComing soon

Submission IntelligenceComing soon

Safety IntelligenceComing soon

Executive Portfolio CopilotComing soon