Trial Configuration

The Most Intuitive EDC Suite on the Market

Configuring and Deploying EDC Trials With TrialMaster

Both TrialBuilder® and TrialExplorer® are desktop-based tools and run under Microsoft Windows®, thereby providing a highly productive and responsive environment, complete with a multi-window user interface and drag-and-drop functionality.

Trial Configuration

Trials are configured and managed by an authorized administrator using a tool called TrialExplorer. This is a Windows product that provides a convenient navigator interface for viewing and managing all the trials in the system.

Trials are created either by copying from an existing trial, or by importing a trial definition in XML format. This XML file will have been generated via an export from TrialExplorer on the same server or a different server. In this manner, trial definitions may be effortlessly moved between environments – typically from Development to QA to UAT to Production. TrialExplorer keeps track of the different versions of the trial definition over time.

TrialExplorer supports the following operations:

  • Trial import and export

  • Trial creation, copying and deleting

  • Trial versioning

  • User security for trial design

  • Setting of trial configuration parameters, such as password expiration time

  • Configuration of directories for TrialMaster data imports and exports

  • Mid-study changes

A mid-study change is handled as follows. The designer creates a new version of the trial in TrialBuilder. If change is to be deployed in a different environment – e.g., moving from Development to QA – then the trial design is exported from the source environment and imported into a new version of the trial in the target environment. The administrator then launches the mid-study change dialog and selects one or more sites to be migrated from the old version to the new version.

A sophisticated difference engine detects and processes all modifications between the source and target versions. This includes adding new items to existing forms, changing item properties (such as from enterable to read-only), handling code list changes, and re-executing all changed edit checks and derivations. The mid-study change may be executed on a running system – there is no need for planned downtime. Once the mid-study change is complete, users will see the appropriate changes in TrialMaster. For example, if a new item has been added to a form, those iCRFs will be reverted to an “incomplete” status so that the site user knows to revisit those forms and enter the additional information.

Your onsite clinical research team has one main job — caring for patients.

The TrialMaster Electronic Data Capture (EDC) solution makes it easier for doctors, nurses and other medical professionals to enter and manage their clinical trial data, thereby freeing up the maximum amount of time to care for patients. This ease of use for investigative sites, coupled with state-of-the-art risk-based monitoring (RBM) and analytical tools, means that life science companies can shorten the time to market for essential life-saving treatments.

Anju Software provides leading, strategic eClinical solutions for clinical trials around the globe.

Anju is dedicated to the process of enhancing a patient’s quality of life by reducing the time to market of essential life-saving treatments.

Pharmaceutical, biotechnology, contract research organizations, diagnostic and device firms, and academic medical centers partner with Anju to maximize the value of their clinical research investments and to develop safe and effective healthcare treatments for patients.


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