Forward to: Clinical Ops

Clinical Trial Monitor
Workflows

Ten agent workflows for Clinical Ops — trial enrollment tracking, endpoint analysis, site selection intelligence, competitive trial monitoring, patient recruitment signals, protocol amendment detection, data readout prediction, CRO performance tracking, regulatory inspection monitoring, and clinical operations dashboard — enabling data-driven clinical development decisions powered by comprehensive domain intelligence.

1Trial Enrollment Tracking

AI agent monitors clinical trial site domains and sponsor company pages to track enrollment progress, site activation timelines, and recruitment challenges — providing early warning on enrollment delays.

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Monitor Enrollment Signals
/careers/press/investorsCountries
CLINICAL TRIAL ENROLLMENT TRACKER — 340 TRIALS MONITORED ════════════════════════════════════════════════════════ novartis.com — KISQALI NATALEE (Ph3 Breast Cancer) /investors: Enrollment: 5,101/5,100 — fully enrolled /press: Primary completion expected Q3 2026 SIGNAL: On track — data readout imminent bms.com — RELATIVITY-123 (Ph3 Melanoma) /careers: +18 clinical research coordinators posted /press: 120 sites activated across 22 countries SIGNAL: Enrollment at 68% — 4 months behind target gilead.com — TROPION-Lung08 (Ph3 NSCLC) /investors: Enrollment paused — protocol amendment /press: Safety monitoring committee review completed SIGNAL: Protocol amendment may delay readout by 6 months

2Endpoint Analysis Intelligence

AI agent tracks clinical endpoint data across biotech domains to provide intelligence on primary and secondary endpoint results, statistical significance, and clinical meaningfulness.

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Track Clinical Endpoint Results
/investors/press/blogOpenPageRank
ENDPOINT ANALYSIS — RECENT READOUTS ════════════════════════════════════════════════════════ abbvie.com — Epcoritamab (DLBCL) /investors: EPCORE NHL-5 Phase 3 results Primary: CR rate 39.2% vs 15.3% SOC (p<0.001) Secondary: PFS HR 0.48 (95% CI: 0.38-0.62) /press: Presented at ASH 2025 — late-breaking abstract SIGNAL: Pivotal data — sBLA submission expected Q2 2026 merck.com — Welireg (ccRCC 1L) /investors: LITESPARK-012 Phase 3 topline Primary: PFS HR 0.78 — stat sig but modest effect /press: Subgroup analysis pending SIGNAL: Modest improvement may limit market uptake

3Clinical Site Selection Intelligence

AI agent analyzes clinical research site domains to assess investigator experience, patient populations, regulatory track records, and site capabilities — informing clinical trial site selection decisions.

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Assess Clinical Trial Sites
/about/leadership/case-studiesCountriesOpenPageRank
SITE ASSESSMENT — ONCOLOGY TRIAL NETWORK ════════════════════════════════════════════════════════ mdanderson.org — MD Anderson Cancer Center /about: 1,500+ active clinical trials /leadership: 820 faculty investigators PageRank: 8.4 | Country: US SCORE: 97/100 — Tier 1 site for oncology trials gustaveroussy.fr — Gustave Roussy Institute /about: Europe's largest cancer center /leadership: 340 investigators PageRank: 7.1 | Country: France SCORE: 92/100 — Top EU site for early phase oncology samaritanresearch.com — Community Site Network /about: 12-site network across Midwest US Domain Age: 1,200 days | PageRank: 2.1 SCORE: 64/100 — Good enrollment but limited experience

4Competitive Trial Landscape

AI agent monitors competitor clinical trial activity to map the competitive clinical landscape — tracking trial designs, enrollment targets, endpoint selections, and anticipated readout timelines.

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Map Competitive Trial Activity
/products/investors/pressIAB Categories
COMPETITIVE TRIAL MAP — NASH/MASH LANDSCAPE ════════════════════════════════════════════════════════ Sponsor Drug Phase N= Readout madrigalpharma.com Rezdiffra Mkt — Approved akero.com Efruxifermin Ph3 1,400 2027 lilly.com Tirzepatide Ph3 1,200 2027 novonordisk.com Semaglutide Ph3 1,800 2027 89bio.com Pegozafermin Ph3 900 2026 COMPETITIVE INSIGHTS: Active Phase 3 MASH trials: 8 competitors Total patients enrolled: 12,400+ across programs SIGNAL: Highly competitive — differentiation critical

5Patient Recruitment Signal Detection

AI agent detects patient recruitment challenges by monitoring trial site advertising, patient advocacy group domains, and sponsor recruitment campaigns.

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Track Recruitment Campaign Signals
/about/blog/eventsIAB Categories
PATIENT RECRUITMENT INTELLIGENCE ════════════════════════════════════════════════════════ patientadvocacy.org /events: 3 new clinical trial awareness campaigns launched /blog: "Finding Clinical Trials" content increased 240% SIGNAL: Advocacy groups actively driving recruitment antidote.me — Trial Matching Platform /about: 2.4M patients in matching database /blog: Rare disease trial matching up 85% YoY SIGNAL: Digital recruitment tools improving rare disease enrollment RECRUITMENT CHALLENGE ALERTS: Pediatric rare disease trials: Avg 2.3 years to enroll CNS trials requiring biomarkers: 40% screen failure rate

6Protocol Amendment Detection

AI agent monitors sponsor domains for protocol amendment signals — changes to inclusion/exclusion criteria, endpoint modifications, and dose adjustments that indicate evolving trial dynamics.

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Detect Protocol Changes
/investors/press/complianceOpenPageRank
PROTOCOL AMENDMENT TRACKER ════════════════════════════════════════════════════════ iovance.com — lifileucel (TIL therapy) /investors: Protocol amendment #3 — expanded eligibility /press: Added 2L melanoma + 2L cervical cohorts SIGNAL: Broadening patient population — commercial signal clovisoncology.com /compliance: Protocol amendment — dose reduction added /investors: Safety update to investigators SIGNAL: Safety concern — monitor treatment discontinuation rates

7Data Readout Prediction

AI agent synthesizes domain signals to predict clinical data readout timing — analyzing enrollment pace, site activation, protocol amendments, and investor guidance to forecast key catalysts.

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Forecast Data Readout Timing
/investors/press/eventsOpenPageRank
DATA READOUT FORECAST — NEXT 12 MONTHS ════════════════════════════════════════════════════════ HIGH CONFIDENCE (90%+ timing accuracy): vertexpharm.com — VX-548 Phase 3 → Q2 2026 argenx.com — Efgartigimod CIDP → Q1 2026 MEDIUM CONFIDENCE (70-90%): alnylam.com — ALN-HTT Phase 1 → Q3-Q4 2026 intelliatx.com — NTLA-2001 Phase 2 → Q2-Q3 2026 LOW CONFIDENCE (below 70%): sarepta.com — SRP-9001 confirmatory → H2 2026-H1 2027 (Protocol amendment + enrollment challenges detected)

8CRO Performance Tracking

AI agent monitors contract research organization domains to assess operational performance, capacity utilization, and service quality — informing CRO selection and partnership decisions.

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Assess CRO Performance Signals
/investors/careers/pressCountries
CRO PERFORMANCE ASSESSMENT ════════════════════════════════════════════════════════ iqvia.com — Full-Service CRO /investors: Backlog $30.2B | Book-to-bill: 1.24x /careers: +22% clinical monitors posted globally /press: AI-powered site selection tool launched SIGNAL: Strong capacity — good partner for large Phase 3 iconplc.com — ICON plc /investors: Revenue $8.1B | Backlog $22.8B /careers: Hiring across 48 countries SIGNAL: Broad geographic coverage for global trials medpace.com — Mid-Size Specialist /investors: Win rate improving — 28% in biotech segment /press: Expanded rare disease and oncology capabilities SIGNAL: Best-in-class for mid-size biotech Phase 2-3

9Regulatory Inspection Monitor

AI agent monitors regulatory authority domains and sponsor compliance pages to track GCP inspections, audit findings, and regulatory enforcement actions affecting clinical trials.

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Track Regulatory Inspections
/compliance/press/legalCountries
REGULATORY INSPECTION INTELLIGENCE ════════════════════════════════════════════════════════ CLEAN INSPECTIONS: roche.com — FDA GCP inspection: No observations astrazeneca.com — EMA inspection: Minor observations only NOTABLE FINDINGS: catalent.com — CMO for cell therapy /compliance: FDA Form 483 — 4 observations issued /press: Corrective action plan submitted SIGNAL: Manufacturing quality concern — monitor resolution ENFORCEMENT ACTIONS: FDA Warning Letters issued to clinical sites: 3 this quarter Data integrity concerns flagged: 2 sponsors affected

10Clinical Operations Dashboard

AI agent synthesizes all clinical trial intelligence into an executive dashboard — providing leadership with real-time visibility into trial performance, competitive dynamics, and operational risks across the clinical portfolio.

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Generate Clinical Intelligence Dashboard
/investors/press/complianceOpenPageRankIAB Categories
CLINICAL OPS DASHBOARD — FEBRUARY 2026 ════════════════════════════════════════════════════════ PORTFOLIO STATUS: Active trials: 14 | On track: 9 | At risk: 4 | Paused: 1 Enrollment: 78% average completion Data readouts next 12 months: 6 expected COMPETITIVE INTELLIGENCE: Competitor trials in same TAs: 23 active New competitor IND filings: 4 this quarter OPERATIONAL RISKS: Sites with inspection findings: 2 CRO capacity constraints: 1 flagged
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Generate Clinical Report

Clinical Operations Report — February 2026

EXECUTIVE SUMMARY ──────────────────────────────────────── Clinical trials monitored: 340 domains Competitor programs tracked: 890 trials CROs assessed: 45 organizations Regulatory inspections: 28 tracked KEY INSIGHTS Portfolio largely on track with 9/14 trials meeting milestones. NASH/MASH landscape intensely competitive — 8 Phase 3 competitors. Patient recruitment remains challenging for rare disease programs. CRO capacity tightening — secure commitments for 2027 trials. Protocol amendment rate increasing — review study design early.
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