Forward to: Clinical Research

Clinical Research Intelligence
Workflows

Ten agent workflows for the Clinical Research team — automated clinical trial landscape monitoring, CRO digital footprint analysis, research institution tracking, therapeutic area competitive intelligence, investigator site assessment, protocol design benchmarking, enrollment prediction modeling, endpoint analysis, publication monitoring, and regulatory pathway intelligence — providing comprehensive domain-level clinical research signals.

1Clinical Trial Landscape Monitoring

AI agent continuously monitors CRO, sponsor, and research institution websites to detect new trial announcements, protocol changes, enrollment status updates, and competitive trial activity across therapeutic areas.

1
Scan CRO & Sponsor Websites
/products /press /careers /events IAB Categories Domain Ages
CLINICAL TRIAL LANDSCAPE SCAN — ONCOLOGY Q1 2026 ════════════════════════════════════════════════════════════ CROs MONITORED: 847 domains SPONSORS TRACKED: 1,240 pharma/biotech domains THERAPEUTIC AREA: Oncology — Solid Tumors NEW TRIAL SIGNALS DETECTED: iqvia.com /press: New Phase III trial announcement — ADC combination therapy /careers: 42 new clinical operations roles posted (oncology-specific) /events: ASCO 2026 abstract submission deadline noted IAB: Health & Fitness | PageRank: 7.2/10 medpace.com /press: Partnership with mid-cap biotech for solid tumor trial /products: New decentralized trial platform launched /careers: 28 new oncology CRA positions — indicates pipeline growth Domain Age: 8,412 days | PageRank: 5.8/10 novartis.com /press: Phase II trial in NSCLC paused — safety signal /investors: Updated pipeline slide — 3 new oncology assets added /careers: 67 medical science liaison roles posted globally
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Detect Competitive Trial Activity
Trial Signal
ADC Combination Therapy Wave — 7 sponsors simultaneously posting CRA recruitment for ADC combination trials across 4 CRO domains. /careers page analysis reveals oncology-focused hiring surges at IQVIA, Medpace, Parexel, and PPD, indicating a competitive wave in antibody-drug conjugate development.
COMPETITIVE PRESSURE — ADC space increasingly crowded
Sector Trend
Decentralized Trial Adoption — 34% of monitored CROs now feature /products pages promoting DCT capabilities. Medpace, Science 37, and ICON all launched new DCT platforms in Q1 2026. Sponsors adding DCT requirements to 58% of new RFPs based on /docs page analysis.
GROWING — DCT adoption accelerating across CRO landscape
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Generate Trial Landscape Report

Oncology Trial Landscape — Q1 2026

EXECUTIVE SUMMARY ──────────────────────────────────────── CROs monitored: 847 | Sponsors tracked: 1,240 | New trials detected: 89 Therapeutic focus: ADC combinations, bispecifics, cell therapy Top enrollment regions: US (42%), EU (31%), APAC (27%) KEY FINDINGS 1. ADC combination space seeing unprecedented crowding — 7 parallel Phase II/III trials 2. Novartis NSCLC pause creates potential patient enrollment opportunity 3. DCT adoption at 34% — recommend incorporating hybrid design elements 4. CRO capacity tightening — early engagement recommended for H2 2026 starts 5. ASCO 2026 submissions indicate 12 competing abstracts in our target indication

2CRO Digital Footprint Assessment

AI agent evaluates Contract Research Organization capabilities by analyzing their complete digital presence — service pages, case studies, leadership profiles, and geographic reach — to support vendor selection and due diligence.

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Profile CRO Capabilities
/products /case-studies /leadership /partners Countries OpenPageRank
CRO CAPABILITY ASSESSMENT — SHORTLIST EVALUATION ════════════════════════════════════════════════════════════ parexel.com /products: Full-service Phase I-IV, strong regulatory strategy /case-studies: 18 oncology case studies, 4 ADC-specific /leadership: CMO with 22 years oncology experience /partners: Lab partnerships with Quest, Covance, BioAgilytix /careers: 312 open roles — rapid growth phase Countries: US, UK, Germany, Japan, China, India PageRank: 6.4/10 | Domain Age: 9,847 days syneos.com /products: Integrated biopharmaceutical solutions, commercial + clinical /case-studies: 9 oncology case studies, 1 ADC /leadership: Recent CMO departure — position open on /careers /partners: Commercial integration unique differentiator Countries: US, UK, Germany, Australia PageRank: 5.9/10 | Domain Age: 4,218 days
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Score & Rank CRO Candidates
CRO Assessment
Parexel — Recommended — Strongest oncology case study portfolio (18 vs. industry avg 7). Stable leadership team. Global site coverage in all target enrollment regions. /careers growth indicates investment phase, not attrition. Only concern: rapid growth may strain capacity.
RECOMMENDED — Best fit for ADC combination trial
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Monitor CRO Health Over Time
CRO Digital Health Tracking
2025-08-14 Syneos rebranded from Syneos Health — /about page fully updated
2025-10-22 Parexel added 4 new ADC case studies to /case-studies page
2025-12-03 Syneos CMO departure detected via /leadership page removal
2026-01-15 Parexel opened Japan operations — /contact added Tokyo office
2026-02-08 Syneos CMO role still open — 78 days vacancy, potential instability signal

3Research Institution Tracking

AI agent monitors academic medical centers, university hospitals, and research institutes to identify potential investigator sites, emerging research capabilities, and collaboration opportunities based on their digital presence.

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Map Research Institution Landscape
/about /leadership /press /events Countries OpenPageRank
RESEARCH INSTITUTION MAPPING — IMMUNO-ONCOLOGY ════════════════════════════════════════════════════════════ INSTITUTIONS SCANNED: 2,340 THERAPEUTIC FOCUS: Immuno-Oncology, Checkpoint Inhibitors mdanderson.org /leadership: 3 KOLs in checkpoint inhibitor research /press: 12 IO publications in last 90 days /events: IO symposium scheduled — March 2026 PageRank: 8.1/10 | IAB: Health & Fitness dana-farber.org /leadership: New IO division chief appointed — Dr. Sarah Chen /press: Breakthrough combination therapy data published /careers: Hiring 8 research coordinators — capacity expansion PageRank: 7.8/10
2
Identify Collaboration Opportunities
Institution Signal
Dana-Farber Expansion — New IO division chief plus 8 research coordinator hires signals capacity expansion. /press page shows 3 recent publications in target indication. /events lists upcoming investigator meeting. Optimal timing for partnership outreach.
OPPORTUNITY — Ideal timing for investigator engagement
3
Track Institution Changes
INSTITUTION CHANGE TRACKING — WEEKLY DIGEST ════════════════════════════════════════════════════════════ POSITIVE SIGNALS (expansion/capability growth): mayoclinic.org — /products added CAR-T manufacturing facility page mskcc.org — /careers posted 14 new clinical trial roles clevelandclinic.org — /partners added 3 new pharma collaborations MONITORING SIGNALS: hopkinsmedicine.org — /leadership removed 2 senior investigators uclahealth.org — /press frequency decreased 40% vs. prior quarter RISK SIGNALS: mountsinai.org — /compliance page added IRB restructuring notice

4Therapeutic Area Competitive Intelligence

AI agent maps the competitive landscape within specific therapeutic areas by analyzing competitor pipelines, publication patterns, conference presentations, and strategic positioning across sponsor and biotech domains.

1
Map Competitor Pipeline Activity
/products /investors /press /blog IAB Categories Personas
COMPETITIVE LANDSCAPE — GLP-1 RECEPTOR AGONISTS ════════════════════════════════════════════════════════════ COMPETITORS TRACKED: 34 sponsors in GLP-1 space PIPELINE STAGE: All phases novonordisk.com /products: Ozempic, Wegovy, CagriSema pipeline featured prominently /investors: Q4 earnings: GLP-1 revenue +41% YoY /press: FDA warning letter on manufacturing capacity /blog: NASH indication expansion data forthcoming lilly.com /products: Mounjaro/Zepbound — oral formulation in development /investors: $10B manufacturing expansion announced /careers: 214 GLP-1 related roles — aggressive scaling /press: Phase III obesity data exceeds expectations
2
Identify Strategic Gaps & Opportunities
Competitive Signal
GLP-1 Market Evolution — Domain analysis reveals 12 new biotech entrants in GLP-1 space (domain age <3 years, /products pages featuring GLP-1 assets). Novo Nordisk manufacturing warning + Lilly supply expansion = supply gap opportunity for next 18 months. Oral formulations represent key differentiator.
OPPORTUNITY — Supply-constrained market with new entrants
3
Track Competitive Moves Over Time
GLP-1 Competitive Timeline
2025-09-15 Amgen oral GLP-1 Phase II results posted on /press — strong efficacy
2025-11-02 Pfizer terminated GLP-1 program — removed from /products pipeline
2025-12-18 Roche acquired GLP-1 biotech — /press announcement, integration page added
2026-01-22 4 Chinese biotechs launched GLP-1 /products pages — global expansion intent
2026-02-10 Novo FDA manufacturing warning — /compliance page updated with remediation plan

5Investigator Site Assessment

AI agent evaluates potential clinical trial investigator sites by analyzing hospital system digital presence, research capabilities, patient population indicators, and operational readiness signals from their web properties.

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Assess Site Readiness & Capability
/products /leadership /about /compliance Countries Personas
INVESTIGATOR SITE ASSESSMENT — 120 CANDIDATE SITES ════════════════════════════════════════════════════════════ cedars-sinai.org /products: Dedicated clinical trials office with oncology specialization /leadership: PI with 14 prior ADC trial experience /about: 1,200-bed facility, 45,000 annual oncology visits /compliance: IRB turnaround: 21 days average Personas: Oncologists, clinical researchers SITE SCORE: 92/100 — Tier 1 recommended emory.edu/winshipcancer /products: NCI-designated cancer center with phase I unit /leadership: PI recently transitioned to emeritus status /about: 890-bed facility, diverse patient population /compliance: IRB undergoing restructuring per /compliance page SITE SCORE: 71/100 — Tier 2, monitor IRB status
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Generate Site Selection Matrix

Site Selection Report — ADC Phase III

SITE RECOMMENDATIONS ──────────────────────────────────────── Sites evaluated: 120 | Tier 1: 18 | Tier 2: 34 | Tier 3: 42 | Excluded: 26 Target enrollment: 840 patients across 45 sites TOP 5 SITES BY COMPOSITE SCORE 1. Cedars-Sinai (92/100) — Strong PI, fast IRB, high patient volume 2. MD Anderson (91/100) — KOL investigator, ADC expertise, NCI designation 3. Memorial Sloan Kettering (89/100) — Phase I unit, biomarker capabilities 4. Mayo Clinic (87/100) — Multi-site network, excellent retention rates 5. Dana-Farber (86/100) — New IO chief, expanding capacity, publication focus

6Protocol Design Benchmarking

AI agent analyzes competitor trial designs, endpoint selections, and inclusion criteria by monitoring sponsor websites, CRO case studies, and regulatory guidance pages to inform optimal protocol development.

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Analyze Competitor Protocol Designs
/docs /press /products /blog IAB Categories
PROTOCOL BENCHMARKING — ADC COMBINATION TRIALS ════════════════════════════════════════════════════════════ COMPETITOR PROTOCOLS ANALYZED: 23 active ADC trials DATA SOURCES: /press releases, /docs guidance pages, /blog scientific updates ENDPOINT ANALYSIS: Primary — ORR: 48% of trials | PFS: 35% | OS: 17% Key secondary — ctDNA clearance rate emerging (4 trials, all 2025+) Biomarker stratification: 78% of new trials include HER2-low subgroup INCLUSION CRITERIA TRENDS: Prior lines of therapy: Median 2 (range 1-4) Brain metastases: 65% now allowing stable brain mets (up from 30%) ECOG PS: 0-1 standard, 2 trials allowing PS 2 with restrictions Biomarker requirements: Increasing — 14 of 23 require tissue sample
2
Generate Protocol Optimization Recommendations
Protocol Intelligence
Design Recommendation — Including stable brain metastases (65% of competitors now allow) would expand eligible pool by ~22%. ctDNA as secondary endpoint increasingly standard — consider adding for regulatory dialog. HER2-low subgroup stratification is now expected by FDA per recent /docs guidance page updates.
OPTIMIZE — Include brain mets + ctDNA endpoint for competitive design

7Enrollment Prediction Modeling

AI agent tracks enrollment velocity indicators across investigator sites, patient advocacy organizations, and referring physician networks to predict enrollment timelines and identify recruitment bottlenecks early.

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Monitor Enrollment Velocity Signals
/products /blog /events /contact Personas Countries
ENROLLMENT VELOCITY ANALYSIS — TRIAL ABC-301 ════════════════════════════════════════════════════════════ TARGET: 840 patients across 45 sites ENROLLED: 312 (37%) | RATE: 18 patients/week SITE PERFORMANCE SIGNALS: TOP ENROLLERS (above target): MD Anderson: 34 enrolled (target: 28) — /events shows active recruitment seminars Cedars-Sinai: 29 enrolled (target: 24) — /blog features patient testimonials Mayo Clinic: 26 enrolled (target: 22) — /contact referral portal active UNDERPERFORMING (below target): Johns Hopkins: 8 enrolled (target: 20) — /careers shows coordinator vacancy UCSF: 6 enrolled (target: 18) — /compliance IRB amendment pending Northwestern: 4 enrolled (target: 16) — No /events or patient outreach detected
2
Predict Enrollment Completion
Enrollment Forecast
Projected Completion: Q1 2027 — Current velocity (18 pts/week) insufficient for Q4 2026 target. 3 underperforming sites account for 67% of enrollment deficit. Domain signals indicate fixable issues: coordinator vacancy (Johns Hopkins), IRB delay (UCSF), insufficient outreach (Northwestern).
AT RISK — 2-month delay projected without intervention
3
Generate Remediation Actions
ENROLLMENT REMEDIATION PLAN ════════════════════════════════════════════════════════════ RECOMMENDED ACTIONS: → Johns Hopkins: Flag coordinator vacancy — sponsor to fund temporary CRC → UCSF: Escalate IRB amendment — offer protocol clarification support → Northwestern: Deploy patient recruitment media package + community outreach → Add 5 backup sites from Tier 2 list (avg activation: 6 weeks) → Engage 3 patient advocacy organizations detected via domain monitoring PROJECTED IMPACT: Current rate: 18 pts/week → Projected with remediation: 26 pts/week Revised completion: Q4 2026 (back on target)

8Publication & KOL Monitoring

AI agent tracks key opinion leader activity, publication patterns, and conference presentations by monitoring academic institution websites, medical journal domains, and professional society pages for research intelligence.

1
Track KOL Activity Across Domains
/leadership /press /blog /events OpenPageRank Personas
KOL ACTIVITY MONITORING — ONCOLOGY Q1 2026 ════════════════════════════════════════════════════════════ KOLs TRACKED: 247 across 89 institution domains PUBLICATIONS DETECTED: 34 in last 30 days HIGH-ACTIVITY KOLs: mdanderson.org — Dr. James Morrison /press: 4 new publications (2 in NEJM, 1 JCO, 1 Lancet Oncology) /events: Speaking at ASCO GI, AACR Annual Meeting /blog: Guest editorial on ADC resistance mechanisms INFLUENCE SCORE: 94/100 — Rising KOL in ADC space dana-farber.org — Dr. Sarah Chen (new IO chief) /press: 2 publications on combination checkpoint therapy /events: Organizing Dana-Farber IO Summit — April 2026 /leadership: Bio updated with advisory board memberships INFLUENCE SCORE: 87/100 — Rapidly ascending, engage early
2
Detect Sentiment & Opinion Shifts
KOL Signal
ADC Resistance Narrative Emerging — Dr. Morrison's editorial on ADC resistance mechanisms has been referenced across 7 institution /blog pages. This narrative could impact regulatory advisory committee opinion. Recommend preemptive data package addressing resistance mechanisms in our ADC candidate.
EMERGING CONCERN — Address resistance narrative proactively

9Regulatory Pathway Intelligence

AI agent monitors FDA, EMA, and global regulatory authority websites along with regulatory consulting firm domains to track guidance changes, approval trends, and pathway optimization opportunities for clinical development programs.

1
Monitor Regulatory Authority Updates
/docs /compliance /press /blog Countries Domain Ages
REGULATORY LANDSCAPE MONITORING — ADC GUIDANCE ════════════════════════════════════════════════════════════ fda.gov /docs: Draft guidance on ADC bioanalytical methods — comment period open /press: Breakthrough therapy designation granted to competitor ADC /events: ODAC meeting scheduled for March — ADC combination review ema.europa.eu /docs: Scientific advice procedure updated for ADC combinations /press: CHMP positive opinion on ADC monotherapy indication /compliance: New pharmacovigilance requirements for ADC class pmda.go.jp /docs: Japan-specific ADC development guidance published /press: Conditional approval pathway expanded for oncology
2
Assess Pathway Implications

Regulatory Pathway Assessment

PATHWAY OPTIMIZATION RECOMMENDATIONS ──────────────────────────────────────── 1. Submit BTD request — competitor precedent strengthens case 2. Comment on FDA draft bioanalytical guidance within 60-day window 3. Address new EMA pharmacovigilance requirements in development plan 4. Pursue PMDA conditional approval pathway for Japan filing 5. Prepare ODAC briefing document — March meeting will set ADC precedent TIMELINE IMPACT Breakthrough designation: Saves 4-6 months on review timeline Japan conditional approval: Parallel filing possible, 3-month acceleration EMA PV requirements: May add 2 months to MAA preparation

10Patient Advocacy & Real-World Evidence

AI agent monitors patient advocacy organizations, health literacy platforms, and real-world evidence data sources to understand patient perspectives, unmet needs, and disease burden signals that inform clinical trial design and regulatory strategy.

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Monitor Patient Advocacy Landscape
/about /blog /events /partners Personas IAB Categories
PATIENT ADVOCACY LANDSCAPE — ONCOLOGY ════════════════════════════════════════════════════════════ ADVOCACY ORGS MONITORED: 342 domains FOCUS: Breast cancer, lung cancer, rare tumors komen.org /blog: New content series on ADC treatment access barriers /events: National advocacy summit — May 2026 /partners: 4 new pharma partnerships listed (competitors) PageRank: 7.4/10 | Personas: Patients, caregivers lungcancerresearchfoundation.org /about: Launched patient-reported outcomes initiative /blog: Editorial on clinical trial diversity requirements /events: Patient advisory board applications open PageRank: 4.8/10
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Identify Patient-Centric Intelligence
Patient Signal
Treatment Access as Top Concern — 67% of advocacy /blog content in Q1 2026 focuses on treatment access and affordability, up from 41% in Q1 2025. ADC-specific access barriers mentioned across 12 domains. Consider patient assistance program announcement at ASCO to address narrative.
GROWING CONCERN — Access narrative intensifying across advocacy sites
Partnership Signal
Komen Pharma Partnerships — 4 competitor partnerships detected on /partners page. No ADC-focused sponsor currently partnered. First-mover advantage available for disease awareness collaboration. /events summit provides natural engagement opportunity in May 2026.
OPPORTUNITY — First-mover in ADC advocacy partnership
3
Generate Patient Engagement Strategy

Patient Advocacy Engagement Report

STRATEGIC RECOMMENDATIONS ──────────────────────────────────────── Advocacy orgs analyzed: 342 | Active engagement opportunities: 14 Patient sentiment: Access-focused (67%), diversity-focused (23%), safety (10%) PRIORITY ACTIONS 1. Partner with Komen before ASCO — ADC disease awareness campaign 2. Join LCRF patient advisory board — input on trial design 3. Develop patient assistance program — address access barrier narrative 4. Incorporate PROs from LCRF initiative into trial endpoints 5. Sponsor diversity-focused recruitment at 8 advocacy partner sites EXPECTED IMPACT Trial enrollment diversity: +35% improvement with advocacy partnerships FDA regulatory reception: Enhanced with patient advocacy alignment Brand perception: Positive differentiation in crowded ADC space
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