Why Choose Our Clinical Data Management Services?
Strategic partnerships
at Veranex
Our strategic partnerships with leading platforms empower us to deliver adaptable, best-in-class strategies and services tailored to your needs. At Veranex, we provide affordable support for Medtech sponsors and trials of all sizes, from early-stage development to post-market surveillance. Our fit-for-purpose Clinical Data Solutions (CDS) ensure seamless program continuity, helping you achieve your goals with confidence and efficiency.
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Complex Multi-System Integration for Alzheimer's Clinical Trial Situation
Situation
The T3D-959-202 Phase II Alzheimer's study faced critical data integration challenges when COVID-19 forced a mid-trial transition from paper-based data capture to electronic source (eSource) systems. The complex integration between CRIO eSource, Almac IXRS, and Medidata RAVE EDC resulted in missing, duplicate, and incorrect data that threatened study integrity and delayed critical safety monitoring board deliverables by three months.
Successes
- Successfully identified and corrected root causes of data flow problems between three complex clinical systems
- Eliminated missing and duplicate data issues, ensuring accurate datasets for regulatory compliance
- Streamlined form and field dynamics to support real-time data transmission without compromising study design requirements
Services by Veranex
- Database design optimization and edit check refinement
- Form and field dynamics modification to support multi-system integration
- Custom programming solutions for data mapping and validation
- Root cause analysis and systematic issue resolution
Multi-Component Implant Study with Complex Bilateral Design
Situation
A randomized medical device trial involving multi-component implants faced significant complexity with bilateral subject setup, ambitious timelines, and stringent safety reporting requirements. The study required immediate device deficiency reporting to safety teams, region-specific device access based on ethics committee approvals, and seamless data capture across multiple therapeutic areas including orthopedic repairs and wound therapy applications.
Successes
- Completed multi-component implant studies despite ambitious timelines and bilateral design challenges
- Implemented automated email triggers for immediate device deficiency notifications, ensuring regulatory compliance and patient safety
- Utilized Spotfire-driven centralized monitoring to identify abnormal data trends, enabling faster medical review and improved data interpretation
Services by Veranex
- Database design with bilateral case support and intuitive device identifier selection
- Automated safety tracking with configurable email alerts for AE/Device Deficiency reporting
Biostatistics & Statistical Programming
Biostatistics & Statistical Programming
Our Biostatistics and Statistical Programming turns complex clinical data into actionable insights, ensuring your research drives impactful decisions and successful outcomes.
Data Visualizations
Data Visualizations
Transform your complex clinical data into clear, impactful graphics, empowering stakeholders to easily understand trends and make informed decisions at a glance with our data visualizations.
Regulatory Consulting
Regulatory Consulting
Accelerate Your Regulatory Submission, partner with our regulatory experts to transform your biostatistics into FDA-ready documentation
MDR Consulting
MDR Consulting
Expand beyond FDA compliance with our MDR consulting services, creating a harmonized regulatory approach that aligns your FDA medical device strategy with European requirements for seamless global market access.
