DataLabs® EDC

The DataLabs® EDC solution is uniquely focused on simplifying workflows and delivering superior user experiences. Its advanced EDC features help streamline the entire process starting from study design all the way to collection, management and reporting of clinical trial data.

Many trials continue to utilize paper-driven processes even as sponsors and sites advance toward EDC adoption. The DataLabs EDC application provides a single electronic clinical data management platform to unify the functionality of paper data entry (PDE) with the flexibility of EDC. The unique hybrid capability enables studies to include sites using paper CRFs and supports existing paper processes. The method of data capture can switch at any point during the study.

Unique product convergence between the DataLabs EDC and ClinPhone RTSM applications allows site users to perform real-time randomization and dispensation activities directly with the EDC application without having to log into IVR or IWR systems. The tight interoperability with the ClinPhone RTSM solution dramatically simplifies workflows for site and sponsor users.

Available as an on-demand, software-as-a-service (SaaS) application with subscription-based pricing, customers benefit from rapid and efficient EDC deployment without high upfront costs, system investment or ongoing maintenance issues. The DataLabs EDC solution means total flexibility and ease-of-use for customers of all types and sizes.

Key Features

  • EDC and paper data management in one powerful system
  • Access ClinPhone RTSM (Randomization and Trial Supply Management) functionality directly from EDC
  • Available as an on-demand, SaaS application with subscription-based pricing
  • Robust reporting capabilities including dashboards, standard reports and ad hoc reports
  • Flexible CRF flag options for full range of review types

DataLabs Designer

To ensure success EDC deployment for a study, it is critical for study teams to transform a protocol into a study easily and efficiently. Without a user friendly design tool, the process of building EDC studies becomes protracted and laborious.

DataLabs Designer innovative web-based study design tool allows users to efficiently build DataLabs EDC studies. Through an intuitive interface and streamlined features, users are able to create new studies by choosing study design components from an extensive,
centralized repository, easily configured CRFs, coding dictionaries, code lists, derivations and built-in edit edits. In addition, the ability to reuse forms and other components from existing or completed studies ensures highly efficient and convenient build process for users.

As a web-based tool, DataLabs Designer is accessible anywhere in the world with no software installation required. DataLabs Designer promotes collaborative authoring and facilitates rapid study builds that decrease overall study start-up time. Built with utmost flexibility in mind, its deployment model allows implementation within the client environment or through hosting services from Perceptive Informatics.

Key Features

  • Ability to import existing study designs using XML
  • Promotes and supports CDISC standards for eCRF design
  • Simple drag-and-drop features
  • Over 30 keyboard shortcuts, i.e., hotkeys
  • Streamlined capability for bulk editing
  • Supporting both VBScript and VB.NET
  • Multi-user support and secure user authentication

See Also

  • The DataLabs® EDC solution is part of Perceptive MyTrials. Perceptive MyTrials provides an application framework through which we are able to converge our integrated suite of clinical trial software applications. Designed to maximize the benefit of natural trial process workflow, MyTrials enables users to plan, design and conduct their clinical trial programs from a single place. To discover how the combination of our products brings increased value and utility to your studies visit: http://www.parexel.co.jp/perceptive/mytrials/.