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.

Integrated Project and Data Management Services

 

Successful clinical trials depend on seamless coordination across clinical sites, laboratory operations, sample logistics, and data systems. Versiti offers a unified project and data management model, with specialization dedicated within two critical domains:

  • Clinical Trial Project & Data Management focusing on trial execution, site management, regulatory alignment, and clinical data integrity.
  • Laboratory Project & Data Management focusing on assay workflows, sample lifecycle oversight, laboratory quality data, and deliverable readiness.

This approach ensures every step, from enrollment to final dataset, is aligned, traceable, and sound.

Clinical Trial Project Management

Operational leadership across study startup, execution, and closeout.

Versiti’s clinical project managers serve as your central point of coordination, ensuring that sites, vendors, and internal teams operate in lockstep against study timelines.

Core Capabilities Include:

  • A dedicated Project Manager for your trial
  • Study timeline management
  • Operational strategy
  • Planning for risk mitigation
  • Conflict resolution
  • Oversite of trial processes

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:

  • EDC development and data management
    • Multisource data acquisition and harmonization (eSource, ePro, eConsent, IRT)
    • Data validation and discrepancy resolution for quality and compliance
    • Interim data reviews to support DSMB
    • Export of clean, submission-ready datasets (CDISC-compliant SDTM/ADaM formats)
 
Data Management
 
Data Collection
 
Customized Strategies

Biostatistics in Clinical Trials

Core Capabilities

  • Interim data reviews to support Data Safety Monitoring Boards (DSMB)
  • Statistical analysis planning, programming, and interpretation
  • Data Analysis
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Laboratory Project Management

Operational oversight of laboratory and logistics workflows and deliverables

Laboratory project managers ensure the scientific and logistical execution of your sample testing strategy while maintaining chain-of-custody integrity and turnaround times.

 

Core Capabilities

  • Assay setup/tech transfer coordination
  • Laboratory workflow scheduling and capacity management
  • Sample intake, accessioning, and LIMS-driven tracking
  • Cold-chain logistics oversight and troubleshooting
  • Communication of testing status and data readiness to the sponsor
  • Root cause evaluation and corrective action planning for lab-based issues

Laboratory Data Management

High-integrity laboratory data aligned to output requirements

Lab data management focuses on ensuring that raw and derived laboratory data are accurate, traceable, and ready for integration into clinical data systems.

 

Core Capabilities

  • LIMS configuration and data structure alignment
  • Data cleaning, QC review, and results verification
  • Transfer specification development for EDC/CRF compatibility
  • Integration of lab results into clinical datasets via secure pipelines
  • Audit trail documentation and traceability reporting
  • Support for interim and final data deliveries

Project and Data Management Services for your unique project

Versiti delivers data integrity, connecting protocol execution, sample lifecycle management, laboratory output, and statistical analysis under coordinated project oversight. Let’s discuss your unique project today

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