Data & Project Management

At Versiti Clinical Trial Services, we provide dedicated project and data management teams to support your clinical trials from start to finish.

 

At Versiti Clinical Trial Services, we provide dedicated project and data management teams to support your clinical trials from start to finish. Our experienced specialists streamline every stage—from study setup to data reconciliation—ensuring efficiency, accuracy, and proactive issue resolution.

What is Clinical Trial Project Management?

Project management in clinical trials refers to the end-to-end coordination of study operations, timelines, and stakeholder communications. At Versiti, our dedicated clinical project managers serve as your operational hub—ensuring proactive issue resolution, sample logistics oversight, and seamless alignment across all functional areas.

Core responsibilities of Versiti’s clinical trial project management include:

  • Study startup coordination, including protocol review, custom kit design, and logistics planning
  • Cross-functional collaboration across lab services, data teams, and supply chain
  • Sample tracking and cold-chain logistics, ensuring timely, compliant specimen handling
  • Sponsor and site communication management with structured updates and escalation protocols
  • Site training and onboarding, including sample collection and shipping best practices
  • Ongoing timeline monitoring to track deliverables and avoid delays

With Versiti, clinical project management is more than oversight, it's a strategic partnership that drives study success.

What is Data Management in Clinical Trials?

Data management is a critical function in the clinical trial lifecycle, encompassing the planning, collection, validation, cleaning, and analysis of clinical data to ensure accuracy, protocol compliance, and regulatory readiness. It serves as the backbone for credible evidence generation and submission-quality datasets.

Key clinical trial data management functions at Versiti include:

  • Multisource data acquisition and harmonization (EDC, LIMS, ePRO)
  • Real-time data validation and discrepancy resolution for quality and compliance
  • Lab-to-CRF reconciliation and traceability across data sources
  • Audit trails, query handling, and compliance with GCDMP standards
  • Interim data reviews to support DSMB, adaptive trial designs, and real-world evidence generation
  • Export of clean, submission-ready datasets (CDISC-compliant SDTM/ADaM formats)
  • Accurate data leads to credible results. Versiti delivers data confidence you can build approvals on.
 
Data Management
 
Data Collection
 
Customized Strategies

Why Sponsors Choose Versiti

  • Dedicated project and data teams with diagnostics expertise
  • Tailored kit development and sample management
  • Integrated data solutions and cold-chain coordination
  • Comprehensive site training and responsive support

Let Versiti streamline the complexity of clinical trial execution—so you can focus on innovation and outcomes.

 
Regulatory Guidance & Global Filings
Versiti offers expert regulatory strategy and global filing support to accelerate approvals, reduce costs, and ensure compliance worldwide.
 
Quality Strategy Services
Ensure regulatory readiness and GxP compliance with Versiti’s expert-led validation, auditing, training, and remediation services for clinical research.
 
Protocol Writing & Management
Streamline your clinical trial process with Versiti Clinical Trials’ expert protocol writing, management and reporting services, ensuring compliance, accuracy and efficiency.