Comprehensive Clinical Trial Services and Capabilities
From study design to regulatory filings, Versiti Clinical Trials provides tailored solutions to meet your research and development needs.
At Versiti Clinical Trials, we provide a full suite of services designed to support sponsors through every stage of the clinical trial process. Our multidisciplinary team brings expertise in laboratory testing, logistics, project management, regulatory strategy and much more. With nearly 30 years of experience, we are dedicated to ensuring your study's success from start to finish.
Our services are tailored to meet the unique needs of each clinical trial. Explore our comprehensive capabilities below:
- Central lab services
- Esoteric testing services
- HLA typing services
- Molecular diagnostics
- Infectious disease testing
- Biomarker development and validation
- Custom assay development/product development
- Companion diagnostic testing
- AAHRPP-accredited IRB services
- Leukopaks
- Non-transfusable/prospective collections
- Collection kit design, assembly and biologistics
- Sample storage and biorepository services
- Specimen handling and site logistics
- Clinical supply provision
- Comprehensive project management
- Study design, feasibility, site identification, qualification and monitoring
- Protocol data management and reporting
- Data management and clinical data reconciliation
- Regulatory authority guidance
- Regulatory strategy and pathway mapping
- Global regulatory filings
- Quality strategy services
- Technical and scientific writing
- Formulation, CMC development and Oversight
Versiti Clinical Trials provides end-to-end trial management services for the successful execution of clinical studies. From Kit Design and Sample Handling to Study Design, Protocol Writing, and Data Management, we strive work as an extension of your team. Our dedicated experts navigate the trial landscape to provide consultative and collaborative recommendations to enhance trial efficiency, provide scalability to support trials of all sizes, and ensure your project is completed on time, within budget to bring innovative therapies to market.
Collection Kit Design & Assembly
Specimen Handling & Site Logistics
Project Management
Study Design & Site Selection Services
Data Management & Reconciliation
Protocol Writing, Management & Reporting
Clinical Supply Provision
Versiti’s deep expertise in laboratory and research services provide critical benefits to clinical trial sponsors and researchers by enhancing precision, efficiency, and compliance throughout the drug development process. Our team of experts have decades of experience in esoteric diagnostic testing, assay development, infectious disease testing, HLA typing and more. Our commitment to the highest quality laboratory services is demonstrated by robust accreditations and quality systems. Together these services enable precise, reliable, and efficient solutions for therapeutic innovation.
Central Lab Services
Estoteric Testing Services
Biomarker Development & Validation
HLA Testing & Cell Transplantation
Molecular Diagnostics
Infectious Disease Testing
Companion Diagnostic Testing
Formulation, CMC Development, Strategy Services & Oversight
Versiti’s Quality and Regulatory services equip therapeutic developers with the expertise to navigate complex regulations and ensure compliance. We work to advise and streamline regulatory strategies, optimize global filings, and enhance submission quality through expert scientific writing. Quality strategies and vendor management improve efficiency and ensure robust processes, while our accredited IRB services through Salus IRB and Pearl IRB safeguard ethical oversight and trial integrity. By minimizing risks and optimizing timelines, these services help developers focus on delivering innovative therapies to patients efficiently.