Flexible Engagement Models
We collaborate through our standard full-scope contract model and FSP (Functional Service Provider) arrangements. Our goal is to be a leading provider of efficient, high-quality clinical trial data management and EDC solutions, specializing in rapid deployment, seamless integration, and exceptional client support to accelerate drug development and ensure data integrity across the industry.
- Adapts to client timelines and time zones, focusing on quality from the outset with a quality-by-design approach
- For adaptive trials and first-in-human (FIH) studies, we can accelerate the timeline to production in just 5-6 weeks for Phase 1 studies
- Global team providing around-the-clock coverage across therapeutic areas
Re-Starting a Phase II Alzheimer's Study with eSource-EDC-IXRS Integration
Situation
A Phase II Alzheimer's disease study needed to be re-activated post-COVID with remote monitoring capabilities through eSource integration. The study required complex three-way integration between CRIO eSource, Medidata RAVE EDC, and Almac IXRS systems, but experienced significant data synchronization issues including missing, duplicate, and incorrect data after going live.
Successes
- Met Critical DSMB Deadline - Successfully implemented targeted fixes to enable data transfer and meet the Data Safety Monitoring Board milestone despite integration challenges
- Stabilized Data Pipeline - Implemented form-level granular data processing and rule-aware validation to create a more stable integration ecosystem
- Enhanced Database Design - Successfully updated database design, edit checks, dynamics, and custom functions while removing unnecessary datapoints to streamline integration
Services by Veranex
- Database Optimization
- Data Reconciliation
- Gap Analysis and Reporting
- Technical Documentation
Clinical Data Management Rescue Study Expertise
Situation
Clinical trials often require rescue interventions when previous vendors have created data quality issues, database build problems, or operational challenges that compromise study integrity. These rescue studies demand specialized expertise to salvage compromised trial data while maintaining regulatory compliance and scientific validity.
Successes
- Comprehensive Problem Assessment - Developed systematic gap analysis approach covering protocol adherence, database design assessment, and data quality evaluation
- Flexible Solution Framework - Successfully implemented three distinct rescue approaches: new database creation, URL transfer, and data cleaning under existing vendors based on study needs
- Risk Mitigation Excellence - Effectively managed time restrictions, resource allocation, and regulatory compliance challenges inherent in rescue study scenarios
- Stakeholder Communication - Maintained transparent communication among sponsors, investigators, and regulatory authorities throughout rescue processes
Services by Veranex
- Initial Assessment and Planning
- Database Solutions
- Data Quality Restoration
- Documentation and Compliance
Trust Veranex to Rescue Your Clinical Study
Veranex delivers specialized clinical rescue services for studies facing timeline delays, cost escalations, and data quality issues. Our experts restore study credibility through comprehensive root cause analysis, collaborative sponsor partnerships, and custom intervention strategies.
Our solutions include:
- Database reconstruction to strengthen data integrity
- Seamless data migration to improved management systems
- Comprehensive remediation of errors, gaps, and inconsistencies
We maintain strict regulatory compliance and quality standards, ensuring rescued trials deliver valid, actionable results. Partner with us to overcome study challenges and achieve successful completion.
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.
Medical Writing
Medical Writing
Transform your complex clinical findings into compelling regulatory submissions that accelerate approvals and bring life-changing therapies to patients faster with our expert medical writing.
FSP
FSP
Partnering with FSP for your medtech clinical trial ensures access to specialized expertise and streamlined resources, empowering you to navigate complexities efficiently and achieve successful outcomes.
Pharmacovigilance
Pharmacovigilance
Our Pharmacovigilance services transform safety data into proactive protection, ensuring patient wellbeing while safeguarding your drug development timeline from regulatory surprises.
