The DigiData Clinical Trial Management System provides a multi-modular solution to the process of Clinical Trial Management

  • Electronic data collection into a structured database

  • Standardisation of data selection and data entry that improves the accuracy and quality of the data collected

  • Participant attendance monitoring and follow up initiation

  • Document image collection and storage of trial related documents in one common system

  • Workflow functionality that manages the completion of processes and tasks because of data collection. E.g., Clinical staff may collect data that is then routed to the PI/SI for review.

  • Communication functionality that automates the sending of SMS messages to trial participants or internally within the organisation.

  • A Realtime designed reporting Dashboard that allows immediate access to all data in the system at Trial, Site and Participant level for performance reporting, information access and analysis. The dashboard provides views of all data in the system and an additional ‘download’ capability where any data can be further downloaded directly from the Dashboard screens into Excel and then re-fashioned by the end user for further analysis or reporting.

  • Access and permission control that ensures that access to information and system function is suitably restricted.

  • Auditability is a key requirement for clinical trials and the system stamps every transaction with the user ID and date and time stamp of the originator.

The DigiData Clinical Trial Management System provides access from both mobile and static devices including smart phones, tablets, laptops, and PCs from any location with Web access. The system can be stored in the cloud or on a dedicated server within the organisation network.

Key Functionality

Multiple Trials
Multiple clinical trials are managed simultaneously. The solution maintains the complete history of each trial for an indefinite period.

Privacy

Biographical details are secured for access by authorized personnel for emergency contact, the initial collection of identity data and contact details during enrollment are hidden.

Participant Identification

At all points of contact the Participant is identified by manually inserting the unique participant code or the use of biometric scanning. Biometric scanning is also used as a means of electronic signature at necessary points in the trial process.

Documentation and Images

As per GCP guidelines and regulations, advanced document management facilities control images/photographs of:

Test Results

Participant and Clinical Staff supporting documentation

Clinical Trial Sponsor documentation

Contracts

IP information documents

SAE reports

These images can be scanned or imported into the system. Documents are consolidated with trial data.

Active Participant Messaging (SMS or USSD)

The DigiData Workflow Management Solution allows for prescribed data captured by clinical staff to be routed to assigned management staff such as the Principal Investigator for review and approval/acceptance/action.

The workflow will also initiate follow-up tasks to the locator team for missed visits.

Administration staff are notified when a participant visit is completed for and that the stipend can now be paid and recorded.

This workflow routing can be accompanied by an SMS message or an email to the receiving party to alert them that a response action is required.

Process Workflow Management

A comprehensive logging and messaging capability to send messages to participants including notification and reminders of scheduled visits and/or missed appointments.

Notifications are also generated in instances where an adverse test result indicates that the participant seek external medical intervention or return to the facility for intervention.

Messaging can be extended to include active monitoring of participant compliance through an interactive USSD platform which requires confirmation by a participant that the IP has been taken.

Active Clinical Staff Messaging

The system provides a similar comprehensive logging and messaging capability that communicates to trial staff and management. These messages typically notify requests for intervention as part of the process or request a review of participant examinations or test results. They would also include requests for review and authorisation.

Selective Data Downloads

In the process of tracking the progression of a Trial, the history of a Participant or the deployment of a Staff Member, the Dashboard provides a unique caopability. At the point that the system displays the required data at the detail level that is required, the simple selection of a ‘Download’ option on the Dashboard screen extracts the data from the Dashboard and inserts it automatically into an Excel spreadsheet. This can then be used to support unique reporting and analysis.

Randomisation and Stratification

During the configuration of a Clinical Trial, The Group definition supports the definition of the Stratification criteria as well as specific selection criteria as required uniquely for each Clinical Trial. Once defined, the system will randomly automatically allocate Participants to each group. The system conforms to double blinding principles and the Group allocation of the Participant is maintained confidentially in the system and only used for Trial progression reporting. Selected management will have access to the participant group information.

Custom Query Analysis

DigiDataCT provides a Query Analyser that supplements the Dashboard. The Query Analyser allows unique and targeted queries to be built based on any criteria and data in the system. The query will execute and return the selected results required. The query can be stored for re-use.