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.
Custom setup by Sealed Envelope. No two trials are the same and so we do not have a one size fits all policy. Tell us about your trial and we set up the randomisation system to suit. We can offer advice on choice of randomisation protocol, blinding etc.
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.
Investigators randomise patients by simply completing an on-screen form with patient details, inclusion and exclusion criteria. Investigators are immediately shown the treatment allocation.
Features that are not relevant to your trial are not shown to keep the interface clean and useable.
Investigators can view the details of patients they have previously randomised. Administrators can edit the details if necessary.
Trial managers have real-time access to recruitment statistics and are notified by email of every new randomisation.
Trial managers can manage user accounts and code lists so that the drug stocks at sites are known about by the randomisation system.
If appropriate, the trial manager and/or investigator can be given the ability to unblind the treatment allocation for any patient in case of emergencies.
User accounts are by invitation only and are created and managed by a designated administrator. All access to the application is via secure SSL connections.
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 manager.
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