IVR and Web Systems for Clinical Trials

Automated Randomization

Randomization is the key to proving efficacy in clinical trials. UBC automated randomization systems leverage the latest statistical techniques, programming technologies, and validation procedures to ensure treatment group balances and avoid randomization pitfalls that can easily compromise research.

Our systems screen, activate, and document patient activities through a centralized database. They assign each qualified patient to a randomized treatment and automatically send a confirmation to the site and other designated parties. UBC’s meticulous quality assurance procedures include internal testing and final user acceptance testing of each randomization module, both individually and interactively with other IVR system components.

We have the ability to conduct patient randomization using IVR or the web. IVR randomization allows study coordinators to randomize patients by following simple voice prompts via telephone. UBC web randomization involves a visual user interface, allowing study coordinators to select and randomize patients by accessing secure web pages.

Features

Permuted block designs

The systems' permuted block randomization list generator can implement any number of stratification factors, block sizes, and random block sizes with exceptional speed and accuracy.

Dynamic/adaptive balancing

UBC implements all types of dynamic and adaptive balancing techniques, including Efron, Pocock and Simon, Zelen, and minimization. In each case, a computerized program automatically balances patients within each treatment group, at each site, across study sites, and according to any other specified stratification criteria.

Programmed unblinding mechanisms

UBC’s automated randomization systems offer secure, real-time 24/7 telephone or web access to treatment data in double- and triple-blinded studies. Each system includes the ability to designate individuals who are authorized to unblind subjects and provides pre-programmed password protection, eliminating the need for time-consuming person-to-person authorizations when patient unblinding becomes critical. Enhancing this safety feature is the automatic distribution of notifications and tracking of history when a subject is unblinded.

Benefits

• Easily accommodates complex stratifications
• Prevents treatment group imbalances
• Provides real-time reporting of randomization in progress
• Includes expert evaluation of randomization before implementation
• Dramatically reduces human error
• Improves data reliability
• Saves time and money