Optimize Your Clinical Trials with Expert Project Operations (Clinical Operations & Project Management) with YouV.
Our leadership team, across all services, brings over 75+ years of team experience, and the entire team has 120+ years of experience
Empowering Clinical operations 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:
- Conducting feasibility studies to assess country and site suitability
- Identifying, evaluating, and selecting investigative sites
- Site qualification visits and investigator assessments
- Regulatory document preparation and submissions
- Site contracting and budgeting
- IRB/ethics committee submissions and approvals
- Site initiation and training
- Developing and implementing patient recruitment strategies
- Utilizing digital and patient outreach tools
- Patient engagement and retention programs
- 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 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
- 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 strategy and submission management
- Ensuring compliance with ICH-GCP, FDA, EMA, and local regulations
- Supporting regulatory inspections and audit readiness
- 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
- 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
- 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
- Reviewing and optimizing clinical trial protocols for efficiency
- Developing and implementing SOPs for clinical operations
- Streamlining processes to reduce time, cost, and resource usage
- 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 assessment using KPIs and KRIs
- Identification of underperforming sites and implementation of corrective actions
- Supporting site teams with metrics-based performance feedback
- 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
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
Why Choose YouV?
Personalized Service
We understand that every project is unique. Our dedicated teams offer tailored solutions, ensuring your specific needs are met with precision, fostering strong relationships and seamless communication for successful outcomes.
Flexibility & Agility
As a mid-sized CRO, we’re nimble and responsive, adapting swiftly to changes. Our agility keeps your trials on track and within budget, offering a faster, more personalized service than larger CROs.
Senior-Level Expertise
With over 75 years of combined experience, our leadership team offers direct access to seasoned operational, scientific, and medical experts, guiding you through complex regulatory landscapes and optimizing trial designs.
Comprehensive Services
From feasibility studies to patient recruitment, data management, and report writing, we cover all aspects of clinical operations. We provide both stand-alone and FSP/FSO models, including site monitoring, centralized monitoring (CzM), and risk-based monitoring (RBM). Our boutique dashboarding solutions for CTMS, e-consent, and more ensure data integrity, reducing timelines and improving quality.
Commitment to Quality
Quality drives everything we do. Our robust quality management systems and risk-based monitoring strategies ensure your trials meet regulatory standards, with KPIs, KRIs, and KQIs guiding data-driven decisions and continuous project improvement.
Why Choose YouV?
We understand that every project is unique. Our dedicated teams offer tailored solutions, ensuring your specific needs are met with precision, fostering strong relationships and seamless communication for successful outcomes.
As a mid-sized CRO, we’re nimble and responsive, adapting swiftly to changes. Our agility keeps your trials on track and within budget, offering a faster, more personalized service than larger CROs.
With over 75 years of combined experience, our leadership team offers direct access to seasoned operational, scientific, and medical experts, guiding you through complex regulatory landscapes and optimizing trial designs.
From feasibility studies to patient recruitment, data management, and report writing, we cover all aspects of clinical operations. We provide both stand-alone and FSP/FSO models, including site monitoring, centralized monitoring (CzM), and risk-based monitoring (RBM). Our boutique dashboarding solutions for CTMS, e-consent, and more ensure data integrity, reducing timelines and improving quality.
Quality drives everything we do. Our robust quality management systems and risk-based monitoring strategies ensure your trials meet regulatory standards, with KPIs, KRIs, and KQIs guiding data-driven decisions and continuous project improvement.
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.
Case Studies.
Adding value to your businesses through our services
Other Expertise.
Regulatory Support Services
Clinical Data Management
Biostatistics
Pharmacovigilance
