AuroraPrime Control
Clinical Trial Randomization and Trial Supply Management System

Prime Control the randomization & trial supply management system on Yaocheng's AuroraPrime clinical study platform. Designed with a highly scalable and configurable SaaS (software as a service) architecture, Prime Control's key features include randomization of subjects, randomization control, drug dispensation, logging, and management in support of complicated randomized controlled trials and efficient, flexible drug management.

Modules
  • Randomization Subjects

    Prime Control can randomize subjects based on a number of randomization methods including simple randomization and stratified block to meet the needs of different RCTs. It supports randomization of different cohorts according to their respective randomization methods, double-confirmation of subject information during the randomization process to ensure correct assignments, as well as printing of randomization confirmation.
  • Randomization Management

    Prime Control supports randomization list upload to help with timely review of randomization list by randomization specialists. Unused randomization lists can be deleted.
  • Randomization Configuration

    Integrated into the AuroraPrime clinical study platform, Prime Control allows randomized trials to be configured across the board in Prime Construct (trial database build system). Prime Control supports randomization requirements, randomization design configurations as well as stratified randomization and independent Cohort in complicated RCTs. The product empowers users to implement protocol amendments independently in a quick and efficient fashion.
  • Drug Dispensation

    Prime Control supports drug dispensation according to the input minimum package unit as well as dose calculation based on dispensing rules. The system supports double-confirmation of drug dispensation info to reduce dispensation errors and dose calculation mistakes as well as support dispensation changes. The user can re-enter data to updated calculated dosage to complete dispensation. Drugs can also be replaced or revoked during the dispensation process. Dispensation information can be printed.
  • Drug Management

    Prime Control lets users browse a list of central depots in the study on the main interface of Drug Management, and view the types of drugs and related information in each depot. Users can access the Central Depot Management module and perform various operations according drug state. Drugs can be received, quarantined, reclaimed, returned to the depot, and destroyed.
  • Drug Records

    Prime Control lets users browse records of received shipping packlist and all drugs on the list. Users can view the records of drugs that have been dispensed, returned, and destroyed, including relevant information. Users can view the records of the returned packlist and view the list of all drugs on a packlist under Details. Users can view a summary of drug receipt, dispensation, reclaimation, return, and destruction records. Users can view the drug dispensation and drug reclaimation status of a single subject's drugs under different visits.
  • Drug Configuration

    Prime Control supports the configuration of a variety of drugs to meet the trial scenarios of unmasked drugs, masked drugs, and both. Users can configure complicated dose calculation rules to automatically compute the number of drug dispensations, dispense drugs according to different dose groups, and support users to update the dispensation plan, dispensation rules, and dose calculation in a timely and autonomous manner when the protocol has been amended.
Features
  • Supports Complicated Randomization Designs

    As trials become more complicated with the increasing application of cohort, Prime Control supports flexible cohort design, each cohort supporting an independent randomization design and can set a specific drug dispensation plan or rule for each cohort.
  • Supports Complicated Drug Dose Calculations

    With the support of the powerful logic engine of Prime Construct, Prime Control can perform complicated calculation and calculation rules configuration based on any data point entered in the CRF and automatically derive the number of drugs to be dispensed to meet the needs.
  • Easy-to-Configure Randomization Designs and Design Changes

    Prime Control's unified and streamlined configurations in Prime Construct can greatly shorten the configuration and system validation time of randomization designs, drug dispensation rules, and drug dispensation plans.
  • Automatic and Complete Drug Records

    Prime Control automatically generates drug-related reports in real-time, including reports on various dimensions such as "received", "dispensed", "destroyed", "subject drug records", etc. It also supports the export of related reports, which greatly reduces the time for drug-related verification.
Benefits
  • Easy to Configure and Make Global Changes

    Unified and streamlined configurations can improve efficiency while ensuring data consistency and reducing repeated confirmations. It is very convenient to implement trial protocol amendments and can be performed by users independently, which shortens the change management cycle and increases responsiveness to changes.
  • Integrated System Reduces Reliance on Individuals

    Data between Prime Control and Prime Collect can be seamlessly communicated, and various operations such as enrollment, randomization, and drug dispensation can be completed without switching systems, achieving absolute data consistency. Through the integrated platform, the repeated data entry as well as potential manual input errors are reduced. Less configurations need to be performed with improvement in verification efficiency.

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