hiive health for
Decentralized Clinical Trials
Accelerating Patient Recruitment and Multi-Site Coordination Through Intelligent Trial Workflows
the overview
With 80% of clinical trial attempts failing to enroll and 55% of trials terminated due to low recruitment, CROs face unprecedented pressure to operate more efficiently. Decentralized Clinical Trials (DCTs) represent a fundamental shift toward patient-centric research, but require sophisticated workflow orchestration and data management capabilities that traditional clinical trial management systems cannot provide. Hiive Health's integrated DCT platform reduces recruitment timelines, improving patient retention, and streamline site coordination and change management through intelligent workflow automation
the challenge
Clinical research leaders face escalating operational challenges that directly impact trial success and organizational sustainability:
Patient Recruitment Crisis
Patient recruitment and retention remain top challenges causing significant delays, with traditional site-based approaches excluding patients due to geographic barriers, mobility limitations, and competing life demands.
Multi-Site Coordination Complexity
Research teams manually coordinate across dozens of sites using email, spreadsheets, and phone calls, leading to protocol deviations, inconsistent data collection, and significant administrative overhead.
Technology Integration Failures
DCT implementation requires integration between CTMS, EDC, ePRO, eConsent, and remote monitoring platforms, creating technical complexity that overwhelms IT resources and delays trial startup.
Data Quality Concerns
Clinical trial data quality is a top challenge in adopting DCT methods and the primary concern of study teams when it comes to remote data collection.
These challenges directly impact metrics that research leaders are evaluated on: enrollment timelines, budget adherence, data quality scores, and regulatory inspection outcomes.
Hiive Health creates an integrated DCT ecosystem that orchestrates patient recruitment, multi-site coordination, and data collection through intelligent workflows that maintain regulatory compliance while dramatically improving operational efficiency.
key capabilities
Real-Time Protocol Compliance
Multi-Site Workflow Orchestration
Unified platform coordinates protocol updates, training delivery, and data collection across distributed research teams, ensuring consistent execution without manual coordination overhead.
Intelligent Patient Matching
AI-powered algorithms automatically screen potential participants across multiple databases, EMR systems, and patient registries, identifying eligible candidates 3x faster than manual chart review processes.
Hybrid Visit Management
Seamlessly integrates in-person visits, telehealth consultations, home health visits, and remote monitoring into cohesive patient journeys that maximize retention while maintaining data quality.
Integrated Data Collection
Connects ePRO, wearable devices, EMR extracts, and clinical assessments into unified data streams that support regulatory requirements and sponsor reporting needs.
Regulatory Documentation Automation
Generates inspection-ready documentation, audit trails, and compliance reports that meet FDA, EMA, and other regulatory authority requirements.
Regulatory Affairs Directors focused on maintaining compliance, preparing for inspections, and ensuring data integrity in decentralized trial environments.
Research Operations Leaders responsible for improving trial efficiency, reducing operational costs, and maintaining competitive advantages in sponsor relationships.
Clinical Research Directors tasked with accelerating patient enrollment, improving data quality, and ensuring regulatory compliance across multiple concurrent studies.
Technology Leaders working to integrate DCT technologies, reduce vendor management complexity, and support scalable research operations.
Principal Investigators seeking to expand patient access, improve retention rates, and reduce administrative burden associated with traditional site-based research.
