Randomisation (IWR)

One dashboard houses randomisation and data capture needs. The goal is to attain a more secure and error-free environment that is sensitive to the necessary steps of replacement randomisation or patient unblinding during clinical studies.

Randomisation assignment can be managed with options to randomise patients automatically or manually. Stratify by data points (such as patient’s gender and blood result), site, study or other criteria. Randomise from a single static list or dynamically.

This system, which includes the IWR feature, allows users to define stratification factors to select and assign subjects to randomised treatment groups. Users can also assign randomisation records to patients directly in the EDC and include the information in the same data export. Users can randomise to any schema and randomise data remotely using the EDC Study Connect mobile application, available in the Apple Store.

Provide Efficiency, Real-time Flexibility and Decrease Start-up Time with RTSM Solution

Trial supply management 

The EDC system provides real-time status of research inventory, helping coordinate the entire tracking, dispensing and return process. With built-in system checks and guidance, users can:

• Define treatment options.
• Enter, manage and track inventory in shipments and at the site.
• Dispense to patients and undo dispensing if the investigational product is not yet given to the patient.
• Include dispensing details and shipping information from depot to patient in the study data exports associated with each patient’s record.
• Coordinate the entire distribution, tracking and return process using an integrated interface that provides an overview of research inventory.
• Track shipments from depot to depot and manage stock across sites through an auto-resupply option.