Clinical Operations & Project Management
Empowering Clinical Trials with Precision, Innovation, and Flexibility
At YOUV, we are transforming clinical operations with agile project management, advanced data solutions, and patient-centered approaches. Our specialized expertise, paired with real-time data insights, equips your trials with the precision and adaptability needed in today’s complex research landscape.
Our Services:
Feasibility and Site Selection
- Conducting feasibility studies to assess country and site suitability
- Identifying, evaluating, and selecting investigative sites
- Site qualification visits and investigator assessments
Study Startup Services
- Regulatory document preparation and submissions
- Site contracting and budgeting
- IRB/ethics committee submissions and approvals
- Site initiation and training
Patient Recruitment and Retention
- Developing and implementing patient recruitment strategies
- Utilizing digital and patient outreach tools
- Patient engagement and retention programs
Project Management
- End-to-end project oversight and timeline management
- Resource planning, budgeting, and cost management
- Risk management and mitigation planning
- Communication management with sponsors and stakeholders
Centralized and Risk-Based Monitoring (RBM)
- Centralized monitoring of trial data and site performance
- Implementing risk-based monitoring strategies focused on high-risk areas
- Real-time data insights and remote site monitoring
Site Management and Monitoring
- On-site and remote monitoring visits (site initiation, routine, close-out)
- Protocol compliance monitoring and quality assurance
- Query resolution and support for site staff
- Safety oversight and adverse event tracking
Regulatory and Compliance Support
- Regulatory strategy and submission management
- Ensuring compliance with ICH-GCP, FDA, EMA, and local regulations
- Supporting regulatory inspections and audit readiness
Site Training and Support
- Training for site staff on protocol requirements and data collection tools
- Providing ongoing support for sites throughout the study lifecycle
- Offering troubleshooting assistance and continuous training updates
Real-Time Dashboarding and Data Analytics
- Customizable dashboards with KPIs, KRIs, and other metrics
- Real-time data visualization for better decision-making
- Predictive analytics for proactive risk management and trend identification
Vendor and Third-Party Management
- Coordinating with vendors such as labs, imaging providers, and patient recruitment firms
- Managing vendor contracts, timelines, and performance
- Quality oversight and compliance monitoring of third-party services
Protocol and Process Optimization
- Reviewing and optimizing clinical trial protocols for efficiency
- Developing and implementing SOPs for clinical operations
- Streamlining processes to reduce time, cost, and resource usage
Patient Engagement and Retention Services
- Implementing patient engagement platforms and communication tools
- Conducting follow-ups and ensuring patient adherence to study protocols
- Managing drop-out risk and improving overall retention rates
Site Performance Evaluation and Oversight
- Site performance assessment using KPIs and KRIs
- Identification of underperforming sites and implementation of corrective actions
- Supporting site teams with metrics-based performance feedback
Close-Out and Archiving Services
- Conducting site close-out visits and ensuring data completeness
- Trial data archival in compliance with regulatory standards
- Managing final payments and reconciliation for sites and vendors
Enhanced Operations with Real-Time Technology:
Dynamic, Data-Driven Dashboarding and Analytics
Real-Time Dashboarding:
Our advanced dashboards bring all e- tools—CTMS, eTMF, eCRF, Safety Databases—into one integrated view. Customizable reports visualize project health and performance metrics, making it easier to track KPIs, KRIs, and KQIs.
Automated, Predictive Reporting:
Automated reporting and predictive analytics uncover trends and forecast potential challenges. With user-friendly interfaces, you have continuous visibility into trial status, helping you stay a step ahead.
Innovative Monitoring Models for Optimal Results
Maximize Efficiency, Minimize Cost
Our Centralized Monitoring and Risk-Based Monitoring strategies deliver superior results with fewer on-site visits and lower costs. By using real-time data and advanced analytics, we identify risks early and optimize resources, resulting in savings of 20-40% on monitoring costs while maintaining high standards of compliance and data quality.
Our Expertise
Drive Efficiency , Deliver Excellence.
Collaborate with us for seamless Project Operations, combining clinical expertise with strategic management. Contact us today!
