Connected Intelligence for Clinical Trials — One unified platform that breaks down data silos and empowers small-to-midsize biotech to compete at enterprise scale
Accelerate your submission timeline, by 6 weeks, with automated workflows across data management, statistical programming, and safety reporting
Decrease trial operating expenses through automation, reduced rework, and optimized resource allocation across all departments
Double your team's capacity to run concurrent trials without adding headcount — focus talent on strategic priorities
Beat competitors to market with faster database lock, accelerated programming, and streamlined submission processes
Small-to-midsize biotech companies face unique operational challenges that legacy systems weren't designed to solve
Manual processes and disconnected systems add 6-8 weeks to every study timeline giving competitors the first-mover advantage.
Impact: Lost market opportunity, extended burn rateTeams spend 60% of their time on repetitive tasks instead of strategic work inflating costs and limiting your ability to run concurrent trials.
Impact: 40% higher operational costs per studySafety signals and protocol deviations discovered too late putting patients at risk and triggering regulatory questions that delay approval.
Impact: DSMB holds, regulatory delays, reputation riskGrowing your pipeline means proportionally growing headcount you can't scale operations without ballooning your budget.
Impact: Linear growth only, cap on portfolio expansionBuilt specifically for small-to-midsize biotech companies, Capque delivers enterprise-grade capabilities without enterprise complexity or cost giving you the operational speed to compete with the big players.
Break down data silos across your entire clinical ecosystem. Capque's Connected Intelligence platform unifies data management, statistical programming, and quality systems — creating a seamless flow of information that accelerates every workflow.
Accelerate Database Lock, Detect Safety Signals Earlier, Empower Real-Time Decisions
Transform raw clinical data into actionable intelligence automatically clean, validate, and analyze data across all systems while providing cross-functional teams with real-time visibility into study performance, patient safety, and operational metrics.
Automated data standardization, cleaning, and reconciliation eliminate 70% of manual effort and accelerate database lock by 6 weeks
Real-time patient safety profiles with AI-powered trend detection give medical teams comprehensive visibility into every patient's journey
Predictive safety signal detection flag emerging adverse event patterns 14 days earlier than traditional methods
Intelligent query generation and resolution tracking reduce query backlogs and improve site response times
Proactive protocol deviation identification catch issues before monitoring visits and prevent cascading problems
Executive dashboards for portfolio oversight monitor all studies, sites, and KPIs from a single pane of glass
Natural language query engine anyone on your team can ask questions and get instant answers from trial data
Unify data from multiple sources to create safety and analysis dashboard for quick insights
Stay Inspection-Ready 24/7 — Never Scramble for an Audit Again
Maintain continuous regulatory compliance without the administrative burden complete GAMP 5 validation, automated quality checks, and real-time regulatory intelligence all in one place.
21 CFR Part 11 compliant electronic signatures
Intelligent SOP and document management auto-versioning, training tracking, and audit trails
AI compliance auditor continuously scan systems for regulatory gaps and get remediation guidance
Daily FDA/EMA intelligence stay ahead of regulatory changes affecting your studies
Supply chain risk monitoring get early warnings on drug shortages and competitive threats
Automated audit trail management inspection-ready documentation at your fingertips
Deploy Specialized AI Agents That Work 24/7 to Accelerate Every Function
Pre-validated AI agents that automate the most time-consuming tasks across clinical operations from CDISC dataset generation to safety narrative writing to medical information responses.
Generate complete SDTM datasets in 5 days instead of 6 weeks with full mapping documentation
Create analysis datasets following CDISC standards reduce programming time by 85%
Automate 80% of tables, figures, and listings focus programmers on complex analyses
Execute routine data cleaning protocols autonomously free your team for strategic work
Generate ICH-compliant SAE narratives in under 5 minutes clear your backlog in days
24/7 safety surveillance with automated SUSAR identification and DSMB package generation
Generate comprehensive patient summaries for medical review in seconds
Pre-screen cases for physician review flag only the issues that need clinical judgment
Draft CSR sections, investigator brochures, and protocol amendments accelerate medical writing
Process RWE data at scale, draft medical information responses, synthesize competitive intelligence
Generate daily executive briefings with portfolio insights and predictive alerts
Perform automated compliance checks across all systems and flag risks proactively
Complete GAMP 5 validation packages (IQ/OQ/PQ), 21 CFR Part 11 controls, human-in-the-loop workflows, and full audit trail documentation included
Unlike legacy systems that take 6-12 months to implement, Capque is designed for rapid deployment get your entire team productive in under a month.
Complete GAMP 5 documentation following FDA, EMA, PMDA, and Health Canada guidelines no additional validation work required
Capque's validation approach follows regulatory authorities worldwide FDA, EMA, PMDA, Health Canada with perfect inspection record
Stop paying enterprise prices for outdated systems get modern capabilities designed specifically for growing biotech companies
| Legacy eClinical Systems | Capque Platform | |
|---|---|---|
| Setup & Deployment | 6-12 months, disruptive implementation | ✓ 2-4 weeks, works with existing systems |
| Database Lock Timeline | 8-12 weeks of manual work | ✓ 2-4 weeks with automation |
| SDTM/ADaM Programming | 4-6 weeks per study | ✓ 3-5 days with AI agents |
| Team Productivity | Linear scaling — more trials = more headcount | ✓ 2x output with same team |
| Safety Signal Detection | Reactive — found during quarterly reviews | ✓ Proactive — AI detects 14 days earlier |
| Validation Requirements | $150K+ per implementation | ✓ Included — pre-validated packages |
| AI Capabilities | Limited or bolt-on solutions | ✓ Native AI agents throughout platform |
Start with what you need today. Add modules as your pipeline grows. All pricing includes validation packages.
Complete data management, cleaning, and analytics platform with safety signal detection and executive dashboards
Full suite with all modules, unlimited users, and dedicated support
21 CFR Part 11 eSignatures, document management, regulatory intelligence, and audit trail management
Full compliance suite with unlimited signatures and complete audit features
Pre-validated AI agents for SDTM/ADaM generation, narrative writing, safety surveillance, and more
Select individual agents based on your workflow needs
Need specific compliance tools? Select individual modules from our Compliance Cloud suite
21 CFR Part 11 compliant eSignatures
Unlimited signatures • Full validation included
Unlimited users • SSO • Custom workflows
Intelligent SOP and document management
1TB storage • Training tracking • Workflows
Unlimited storage • API access • Custom integrations
AI compliance auditor continuous system scanning
Weekly reports • Priority support • Quarterly reviews
Unlimited systems • Real-time monitoring • Dedicated CSM
Get all three solutions together for the best value. Includes Data Intelligence Suite, Compliance Cloud, and your choice of AI Agents.
See how Capque can help you move faster, reduce costs, and outpace competitors
5-minute video showing SDTM Agent, SafetyWatch, and NarrativeOps in action
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