HSRU provide validated and easy to use online/IVR (telephone) software for randomising patients into clinical trials.
Reasons to choose HSRU for your service:
- Highly experienced staff and reliable online/telephone service.
- Can integrate and export data dynamically to other 3rd party systems.
- Suitable for a wide variety of trial types, customised to your trial.
- Advice on system design and implementations.
- Ongoing export support via online support tool.
Simple randomisation, block randomisation, stratified block randomisation and minimisation are offered as standard. Novel randomisation can be implemented on request.
Telephone randomisation service
HSRU offer a 24-hour, seven-day automated telephone randomisation service, telephone calls are made to the service using a Freephone number, which is connected to 16 telephone lines. For international calls, there is a standard UK telephone number.
Web-based randomisation service
HSRU offer a secure and robust web-based randomisation system. It is accessible anytime, anywhere and via any device that has a modern web browser and is connected to the Internet.
Standard features
A customisable role-based user access control system, email notifications are built in. The randomisation system generates confirmation emails that can be blinded or unblinded to treatment allocation.
Standard reports summarising randomisation and all data-entry activity, custom reports implemented on request.
All transactions are logged, the trial's audit trail and the list of randomisations can be downloaded and analysed at any time by authorised users
Randomisation simulation data is generated before the study begins, to check balance across stratification factors. The system can be programmed to perform validation checks, such as checking for duplicate Participant Identification Numbers and preventing randomisation from proceeding in such cases.
Drug supply chain management
The randomisation service can also handle drug supply chain. Active and placebo unique treatment pack numbers, batch numbers and expiry dates can be programmed into the system, with the system recording packs delivered to specific site/pharmacies and only allocating medication packs that are available at that site. Notifications can be set up to alert site/pharmacies of low drug supply, and this functionality is configurable as required. For example, notify site/pharmacy when the stock level reaches x amount of packs.
Unblinding
We can offer you an emergency online/telephone code break (unblinding) service which is also available 24 hours a day. Investigators break the blind by simply providing the unique randomisation number, or other identifier used for your trial medication or intervention. Investigators are immediately notified of the unblinded treatment allocation. Trial teams can choose to be notified by email of every new code break.
ePRO
Invitations are sent by email, links to complete the forms online are included in the emails. Invites and reminders can be sent automatically via our built-in configurable communication manager.
Implementation and cost
The cost of the service depends on how long the service is required and the sample size. The randomisation request form can be found here.
If you require further information relating to planning a new randomisation service or If you would like a demonstration on either the telephone or web-based randomisation service, please contact the Senior IT Development Manager: Mark Forrest