Clinflash IRT

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Randomization and Supply Management
Clinflash IRT
Supporting complex randomization schemes and trial designs to improve trial efficiency and reduce R&D risks and costs
Professional, reliable and secure randomization and supply management systemClinflash IRT, developed by senior biostatisticians and trial supply experts, supports a wide range of complex randomization scenarios and trial designs. It is compatible with diverse randomization methods and can be closely integrated with Clinflash EDC or other external systems to reduce data duplication and improve trial efficiencyClinflash IRT has been applied in more than 800 clinical research projects over the past few years, including 80+ Phase III registered clinical trials, providing sponsors and CROs with high-quality randomization and supply management solutions to meet the full range of trial requirements of different users
Safe and reliableDeveloped under the leadership of top statistical expertsProfessional randomization process and drug management Subject to two levels of system calibration to reduce potential riskAutomatically monitoring inventory and triggering orders
Flexible to configureApplicable to all types of trials (block/stratification/dynamic randomization/re-randomization)Supporting multiple treatment options: multi-arm studies, fixed-dose dosing, Cohort multi-cluster independent dosing, calculated-dose dosing, weight/age/body surface calculated-dose dosing
Professional and compliantKeeping operation traces and supporting system-wide audit trail traceabilityHigh standard system development and refined process management SOPDeveloped in accordance with GAMP5, complying with CMMI3 certification standards and passing GxP5 system validation
Professional, reliable and secure randomization and supply management systemClinflash IRT, developed by senior biostatisticians and trial supply experts, supports a wide range of complex randomization scenarios and trial designs. It is compatible with diverse randomization methods and can be closely integrated with Clinflash EDC or other external systems to reduce data duplication and improve trial efficiencyClinflash IRT has been applied in more than 800 clinical research projects over the past few years, including 80+ Phase III registered clinical trials, providing sponsors and CROs with high-quality randomization and supply management solutions to meet the full range of trial requirements of different users
Safe and reliableDeveloped under the leadership of top statistical expertsProfessional randomization process and drug management Subject to two levels of system calibration to reduce potential riskAutomatically monitoring inventory and triggering orders
Flexible to configureApplicable to all types of trials (block/stratification/dynamic randomization/re-randomization)Supporting multiple treatment options: multi-arm studies, fixed-dose dosing, Cohort multi-cluster independent dosing, calculated-dose dosing, weight/age/body surface calculated-dose dosing
Professional and compliantKeeping operation traces and supporting system-wide audit trail traceabilityHigh standard system development and refined process management SOPDeveloped in accordance with GAMP5, complying with CMMI3 certification standards and passing GxP5 system validation
Developed under the leadership of top statistical experts, specializing in randomization processes and drug management
Standard randomizationDual system validation (including upload check and real-time cross-check), compatible with a variety of complex clinical trial randomization design schemes, to ensure randomization reliability
Improved blind controlProviding a variety of approval and confirmation mechanisms for emergency unblinding, introducing symmetric encryption-AES-ECB mode to prevent data unblinding, and supporting flexible role permission configuration to ensure data blindness
Reliable distribution and inventory management of study productsAllowing for configuration of trial supply management plans, automatic forecasting of central stocks, automatic order management, with coverage of minimum stocks, enrollment, and drug expiration, and allowing the supply plan changes to take effect during the course of the project
Developed under the leadership of top statistical experts, specializing in randomization processes and drug management
Standard randomizationDual system validation (including upload check and real-time cross-check), compatible with a variety of complex clinical trial randomization design schemes, to ensure randomization reliability
Improved blind controlProviding a variety of approval and confirmation mechanisms for emergency unblinding, introducing symmetric encryption-AES-ECB mode to prevent data unblinding, and supporting flexible role permission configuration to ensure data blindness
Reliable distribution and inventory management of study productsAllowing for configuration of trial supply management plans, automatic forecasting of central stocks, automatic order management, with coverage of minimum stocks, enrollment, and drug expiration, and allowing the supply plan changes to take effect during the course of the project
Deep integration of IRT and Clinflash EDCIRT unidirectional transmission for improved accuracy of randomization and dispensing results
Deep integration of IRT and Clinflash EDCIRT unidirectional transmission for improved accuracy of randomization and dispensing results
Preconfigured modules are fully customisableto effectively address the complexrandomization and supply management needs of all types of trials
Randomization
Supporting complex multi-arm trial design and supporting a variety of randomization schemes of block, stratification, dynamic randomization, re-randomization, and Cohort multi-cluster randomization
Subject management
Providing subject registration, status management, visit plan setting, proactive reminder, and stratified (combined) warning reminder
Supply management
Performing cross-country/regional/center order management, compatible with the inventory ceiling and warning value of the site, as well as automatic inventory warning and replenishment
Site management
Providing standard site library management, site user management, permission assignment, activation and locking
Investigational product release
Supporting complex therapeutic regimens including fixed-dose administration, dynamic-dose administration, drug combinations, with programmable dosage formulas
Reporting & analytics
Providing custom reports covering different system states, including subject randomization, Depot inventory, orders, and site inventory
Direct-to-Patient (DTP)
Supporting the direct delivery of study products from the warehouse/site to the designated patient address, as well as real-time tracking of logistics
External system integration
Allowing for one-way data integration and transmission with external systems (e.g., EDC, logistics systems)
Preconfigured modules are fully customisableto effectively address the complexrandomization and supply management needs of all types of trials
RandomizationSupporting complex multi-arm trial design and supporting a variety of randomization schemes of block, stratification, dynamic randomization, re-randomization, and Cohort multi-cluster randomization
Subject managementProviding subject registration, status management, visit plan setting, proactive reminder, and stratified (combined) warning reminder
Supply managementPerforming cross-country/regional/center order management, compatible with the inventory ceiling and warning value of the site, as well as automatic inventory warning and replenishment
Site managementProviding standard site library management, site user management, permission assignment, activation and locking
Investigational product releaseSupporting complex therapeutic regimens including fixed-dose administration, dynamic-dose administration, drug combinations, with programmable dosage formulas
Reporting & analyticsProviding custom reports covering different system states, including subject randomization, Depot inventory, orders, and site inventory
Direct-to-Patient (DTP)Supporting the direct delivery of study products from the warehouse/site to the designated patient address, as well as real-time tracking of logistics
External system integrationAllowing for one-way data integration and transmission with external systems (e.g., EDC, logistics systems)
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The leading provider of digital solutions and professional services in field of clinical development
Company Hotline：400-803-8655
Business Cooperation：bd@clinflash.com
Technical Support：edchelp@clinflash.com
Jiaxing Office：3rd Floor, Building 3, No. 551 Yazhong Road, Nanhu District, China PRC
Shanghai Office：Room 813, 999 West Zhongshan Road, Huawen Plaza, Shanghai, 200051, P/R. China
Hangzhou Office：16/F, Block A, Shanda Technology Park, No. 19 Jugong Road, Binjiang District, Hangzhou
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The leading provider of digital solutions and professional services in field of clinical developmentCompany Hotline：400-803-8655Business Cooperation：bd@clinflash.comTechnical Support：edchelp@clinflash.comJiaxing Office：3rd Floor, Building 3, No. 551 Yazhong Road, Nanhu District, China PRCShanghai Office：Room 813, 999 West Zhongshan Road, Huawen Plaza, Shanghai, 200051, P/R. ChinaHangzhou Office：16/F, Block A, Shanda Technology Park, No. 19 Jugong Road, Binjiang District, Hangzhou
Clinflash official account
Privacy PolicyService Levels (SLA)
Zhejiang ICP 15024529-3Copyright © 2026 Clinflash International Limited. All Rights ReservedZhejiang Public Network Security 33040202000550
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