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Clinical Data Management

Clinical Trial Data Management Services

Leveraging best-in-class systems, people and processes

Full-Service Clinical Data Management

As a full-service clinical data management provider that leverages best-in-class systems, people and processes, we provide a comprehensive, cost-effective end-to-end solution.

Our service offerings include:
  • Clinical data management plan development
  • Database design
  • Data validation plan preparation (edit check specifications)
  • CRF/eCRF design
  • Data review
  • Data query generating/tracking/reconciling
  • Coding dictionaries for AEs (MedDRA) and medications (WHO Drug), and data coding of all AEs and medications
  • Data transfer specifications
  • Interim analysis
  • Database locking
  • Final datasets transfer to biostatistician

Data Management EDC Platform

Our EDC platform is OmniComm TrialMaster which adds a depth of functionality for a better user experience.

TrialMaster allows us to:
  • Support Phase I – IV clinical trials
  • Capture high quality data with a minimal amount of inquiries
  • Support Adjudication processes
  • Import data from third party sources (including imaging and Central Lab files) for measurement and interpretation
  • Easily enter data from sites
  • Keep study build times to 8 weeks or less (depending on the complexity of the study and the ability to use standard forms)

Increase Quality and Agility with Faster Setup and Execution of Studies

With WCCT you can streamline your drug development endeavor. Through our beginning-to-end, technology-enhanced clinical development optimization services you’ll be able to accelerate and simplify your study design, improve quality, and expedite start-up, execution and submission.

High-Quality Clinical Data

Ultimately, your study is about the data. High-quality clinical data doesn’t result from chance; the methods you use for collecting, interpreting and managing your study data can be the difference between success and failure.

WCCT offers cutting-edge electronic data capture (EDC) solutions or the option to use standard commercial systems such as Rave, InForm, iMedNet and Merge eClinicalOS. We can even work with your own system — whatever works best for your cost, timelines and clinical strategy. Regardless of the system, our focus is on the quality and integrity of the data collected.

Clinical data management services include:
  • Development of the clinical data management plan (DMP)
  • Database design
  • Data validation plan preparation
  • CRF/eCRF design
  • Data entry of CRFs (paper system)
  • Data review
  • Data queries generation, tracking and reconciliation
  • Coding dictionaries generation for AEs (MedDRA) and medications (WHO Drug), and AE and medication data coding
  • Data reconciliation
  • Data transfer specifications
  • Interim analysis
  • Database lock

TrialMaster — A Compelling Solution for Electronic Data Capture

WCCT’s TrialMaster™ Electronic Data Capture Suite offers our clients a unique set of capabilities. By providing the most intuitive end-user experience, it has become the most productive study design tool available — with flexible reporting, off-the-shelf integrations and convenient mechanisms for importing and exporting data.

This proven solution offers advanced features that can add breadth and scope to your clinical research project:
  • Study-specific edit checks
  • Intuitive interface to guide users during the data entry process
  • Data for labs, IVRS or any other source able to be directly imported through CSV files or ODM XMLs
  • Multi-language capable, allowing sites to view native CRFs
  • ePro: direct access that lets subjects enter their outcomes while blinding personal information
  • Customizable exports
  • Optional SDTM submission-ready extracts upon study lock
  • Ad-hoc reporting for live data review
TrialMaster also provides the following services to make your project run more efficiently:
  • Advance edit checks
  • Global library
  • Data grids
  • Real-time validations
  • eLearning
  • Lab normals
  • Risk-based monitoring
  • Central monitoring
  • Auto-encoding
  • Go-live SDTM
  • Fully customizable exports

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