internet

Internet randomisation

Our internet based service allows investigators to randomise patients from anywhere in the world through the convenience of their web browser. This method of randomisation is ideal when all investigators have access to the internet at the point of randomisation.

Easy to use

Investigators randomise patients by simply completing an on-screen form with patient details, inclusion and exclusion criteria. Investigators are immediately shown the treatment allocation.

Investigators can view the details of patients they have previously randomised.

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Tailor made

No two trials are the same and so we don't have a one size fits all policy. If you don't need a feature it's not shown to you to keep the interface clean and useable.

Eligibility criteria, randomisation protocol and patient characteristics collected at randomisation are customised to your trial requirements.

We can add features such as unblinding, rescue medication, maintenance therapy and dose calculations as appropriate.

Extra features

We give you a trial homepage that you can use to give a brief summary of the trial protocol and eligibility criteria of patients entering your trial.

Trial co-ordinators can manage user accounts and code lists so that the drug stock on site is known about by the randomisation system.

If appropriate, the trial co-ordinator and/or investigator can be given the ability to unblind the treatment allocation for any patient in case of emergencies.

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Stay in the loop

Trial co-ordinators have real-time access to recruitment statistics and can choose to be notified by email of every new randomisation.

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Safe and secure

The system is hosted on a dedicated server in a fully audited Rackspace datacentre. The server is protected by a Cisco hardware firewall and daily backup is both onsite to tape and offsite to another server in a different datacentre.

Users require a valid username, password and PIN number to access the randomisation application.

Randomisations are conducted via SSL encryption for added security. The randomisation application conforms to the requirements of FDA 21 CFR part 11, Electronic Records; Electronic Signatures and ICH GCP.

No-one can delete records from the randomisation database, so that all randomisations have to be accounted for.

Audit log files detailing all activity on the randomisation system are available to the trial co-ordinator.

Why not see for yourself? A demonstration of our internet service is available so you can see how the system works first hand. Contact us for access details.