Unify Trials vs Site2Test

The Unify Trials app provides participants in a Clinical trial support and information throughout the trial. Support include reminders for tasks relevant to complete the trial as well as layman information about the relevant disease area and the trial in general. Participants can also provide data through different health questionnaires and other means of data collection. Data can be collected by connected devices in markets and regions where use of devices have regulatory clearance. Use of devices is approved in the US and the EU.

The GSK Site2Test is an application to digitalise the collection activities of samples at clinical sites in order to significantly reduce the time required between sample collection and lab result generation. Features: Access Management: The aim of this process is to identify each action by a user. The site staff member and the laboratory technician will access the login page of the product. He/she will provide email address and password to authenticate to the product and access the different functionalities. Manage subject information: The aim of this process is to uniquely link a study participant (subject) to a QR code. Collect sample: The aim of this process is to collect sample information when samples are collected directly from the subject (e.g., Blood Draw, Nasal Swab…). Prepare sample: The aim of this process is to collect sample information when collected samples are processed at preparation laboratories (e.g., serum separation, plasma preparation…). Manage sample information: The aim of this process is to consult/invalidate or edit sample information related to a tube. Shipment: The aim of this process is to scan samples that will be part of one shipment. Audit Trail: The audit trail records information for each action that creates relevant GxP data such as the identification/link to the associated record/data, the user who made the change, the date or time stamp of change, the specific action, the old and new values, etc.