Distributed randomization and supply management in clinical trials

A system to randomize subjects in a multi-arm clinical trial, the system comprising:

• a computing device;
• and
• a machine-readable medium comprising instructions that, when executed by the computing device, cause the computing device to perform operations comprising:
• receiving at least a subject identifier and a trial identifier from an electronic data capture system, the subject identifier indicating a subject enrolled by the electronic data capture system into the multi-arm clinical trial, the trial identifier indicating the multi-arm clinical into which the subject is enrolled;
• selecting at runtime a randomization design algorithm for the multi-arm clinical trial from a database using the trial identifier, the database storing a plurality of randomization design algorithms associated with respective trial identifiers for a plurality of multi-arm clinical trials;
• and
• executing the randomization design algorithm that randomizes the subject to an arm of the multi-arm clinical trial, the randomization design algorithm assigning the subject identifier to an arm identifier that indicates the arm of the multi-arm clinical trial to which the subject has been randomized.

A non-transitory machine-readable storage medium comprising instructions that, when executed by a processor, cause the processor to perform operations comprising:

• receiving at least a subject identifier and a trial identifier from an electronic data capture system, the subject identifier indicating a subject enrolled into the multi-arm clinical trial, the trial identifier indicating the multi-arm clinical trial into which the subject is enrolled;
• selecting at runtime a randomization design algorithm for the multi-arm clinical trial from a database using the trial identifier, the database storing a plurality of randomization design algorithms associated with respective trial identifiers for a plurality of multi-arm clinical trials;
• and
• executing the randomization design algorithm that randomizes the subject to an arm of the multi-arm clinical trial, the randomization design algorithm assigning the subject identifier to an arm identifier that indicates the arm of the multi-arm clinical trial to which the subject has been randomized.