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 protocol execution, site support, regulatory alignment, and clinical data integrity; and
  • 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:

  • 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

Data Management and Biostatistics in Clinical Trials

Ensuring complete, accurate, submission-ready clinical datasets

Our clinical data management team ensures that data collected throughout the trial is structured, validated, and aligned with regulatory standards.

Core Capabilities

  • Interim data reviews to support DSMB, adaptive trial designs, and real-world evidence generation
  • Statistical analysis planning, programming, and interpretation
  • Data Analysis (i.e. Longitudinal, Survival)
  • Study and Experimental Design
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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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Regulatory Guidance & Global Filings
Versiti offers expert regulatory strategy and global filing support to accelerate approvals, reduce costs, and ensure compliance worldwide.
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Quality Strategy Services
Ensure regulatory readiness and GxP compliance with Versiti’s expert-led validation, auditing, training, and remediation services for clinical research.
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Medical Writing & Protocol Management
Streamline your clinical trial process with Versiti Clinical Trials’ expert protocol writing, management and reporting services, ensuring compliance, accuracy and efficiency.
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