Clinion RTSM - 2026 Pricing, Features, Reviews & Alternatives

Clinion’s Randomisation and Trial Supply Management solution is a clinical trial management software application designed to automate randomisation processes, kit assignment workflows and investigational medicinal product supply chain logistics for clinical research studies. The solution can operate as a standalone module or within an integrated electronic data capture platform and supports studies from early stage through late stage clinical trials. It addresses operational complexities in subject randomisation and global supply chains by providing real time visibility and control over inventory distribution across depots, sites and countries. The solution offers an intuitive user interface to streamline study team operations.

The randomisation functionality supports simple randomisation, block randomisation, cohort based randomisation and stratified randomisation through configuration and upload of a master randomisation list provided by a statistician. Complex dynamic allocation methods required by protocol designs are also accommodated. Subject eligibility validation occurs automatically within the integrated electronic data capture environment to ensure randomisation triggers only after all criteria are met and required data is validated. A user acceptance testing environment replicates the production space to enable simulation of randomisation scenarios and verification of logic against protocol specifications before study activation. The application supports re randomisation in crossover and re treatment study designs and enables configurable emergency unblinding processes that can follow investigator initiated action or a multi step project manager approval workflow, with each unblinding event secured by electronic signature and recorded in the audit trail. Mid study amendments to treatment allocation ratios are managed through controlled configuration updates. The visit and dosing management feature links kit dispensing to protocol defined visit schedules with configurable visit windows that vary by cohort or stratification factor, and real time kit assignment ensures accurate allocation and dosage adjustment for completed visits.

Supply chain management functionality provides end to end visibility across multi depot and multi country configurations with centralised inventory tracking from depot to site level. Automated supply checks use configurable inventory threshold parameters that trigger re supply orders when site inventory falls below specified levels, while automated expiry checks send email notifications for kits approaching expiration based on customisable windows. Site users can generate manual shipment requests through a stock indent feature that captures shipping agency details, tracking number and dispatch date for complete transaction records. The ordering, tracking, temperature excursion and returns workflow supports automated and manual ordering, real time tracking of inventory status, recording of temperature logger data upon receipt and a multi step returns process with project manager approval gates for compliance and accountability. Depot site inventory management offers global tracking of status, shipments, returns and stock levels to support efficient resupply planning and prevent stockouts.

The reporting and analytics framework delivers inspection ready compliance reports, including complete audit trails, user activity logs and unblinding event documentation with time stamped, unchangeable records for regulatory review. Real time operational oversight reports provide on demand access to depot management data, site inventory levels and subject lists to support proactive decision making. All reports are exportable to PDF and Excel formats and built on a CDISC compliant data structure to facilitate regulatory submission. The platform maintains adherence to global regulatory standards including twenty one CFR Part eleven, ICH GCP and GDPR through secure access controls, detailed audit trails and compliant data handling procedures. Integration with Clinion’s eClinical suite of modules enables seamless data flow and unified trial management. The cloud based architecture supports remote access, batch data loading and deployment in two to three days with round the clock technical support to ensure continuous trial operations.