Development Stage

Accelerate Clinical Development

Streamline clinical trials with protocol compliance, data integrity, and automated safety monitoring. Ensure zero protocol deviations and faster database locks while maintaining complete regulatory compliance.

The Development Compliance Challenge

Protocol deviations, data integrity issues, safety signals missed

Clinical development faces constant pressure to maintain protocol compliance while managing complex multi-site trials. Data integrity issues can derail submissions, and missed safety signals create regulatory risks. Traditional approaches struggle to provide real-time monitoring and automated compliance checks, leading to protocol deviations, delayed database locks, and compliance gaps that impact submission timelines.

tfives Development Solutions

ComplianceIQ

AI clinical trial design validation ensures your protocols meet regulatory requirements from the start. Optimize trial designs and validate against regulatory standards.

  • Protocol compliance validation
  • Trial design optimization
  • Regulatory alignment checks

Clinical Trial Compliance

Real-time protocol monitoring ensures complete compliance across all trial sites. Automated alerts prevent deviations before they impact your study.

  • Real-time deviation tracking
  • Automated compliance alerts
  • Site performance monitoring

Pharmacovigilance

Automated adverse event detection and reporting ensures timely safety signal identification and regulatory compliance throughout your clinical trials.

  • Real-time safety signal detection
  • Automated adverse event reporting
  • Risk assessment automation

ClinoxisCore

GxP clinical data management with automated validation and quality checks accelerates database locks while ensuring complete data integrity.

  • Clinical data validation
  • Database lock acceleration
  • Data integrity assurance

Key Outcomes

Minimal Major Protocol Deviations

Real-time monitoring ensures complete protocol compliance across all trial sites

Up to 1% Faster Database Lock

Automated data validation and quality checks accelerate timelines

Comprehensive Timely AE Reporting

Automated pharmacovigilance ensures regulatory compliance