RTSM for Oncology: Dose Escalation, Multi-Arm Supply, and Adaptive Trials
Randomization and trial supply management in oncology is materially more complex than in most other therapeutic areas. Dose escalation designs, combination regimens, biomarker-stratified cohorts, and global supply chains all place demands on RTSM systems that go well beyond simple randomization.
Sitero’s RTSM module, part of the Mentor eClinical platform, is configured for the supply and randomization complexity that oncology programs routinely encounter.
Dose Escalation: Where RTSM Earns Its Keep
Phase I dose escalation trials in oncology require precise control over which patients receive which dose level, when cohort transitions occur, and how supply is allocated as the escalation proceeds. The RTSM system is the operational mechanism that enforces dose assignment rules, prevents protocol deviations at dispensing, and generates the documentation needed for dose escalation committee reviews.
Sitero’s RTSM supports escalation schemes with configurable cohort rules, audit-ready dispensing records, and real-time supply visibility — so that as cohorts expand or de-escalation rules are triggered, the system executes changes accurately rather than requiring manual workarounds.
Multi-Arm and Combination Regimen Supply
Combination therapy trials require supply management across multiple agents, often with different manufacturers, shelf lives, storage requirements, and dispensing schedules. Umbrella and basket trial designs add further complexity by running multiple arms in parallel, each potentially requiring different supply configurations. Sitero’s RTSM manages multi-arm supply allocation, depot-to-site coordination, and real-time inventory visibility to prevent stockouts or expiry events that could delay patient treatment.
Adaptive Supply Management
When trial designs adapt based on interim data — dropping arms, expanding cohorts, adjusting dose levels — the RTSM must execute those changes accurately and quickly. Sitero’s system supports adaptive supply management with the audit trail required to demonstrate that supply changes were executed per protocol.
Global Supply Chain Coordination
Across 67+ countries, Sitero manages the operational complexity of getting investigational product to sites on time. RTSM-driven supply management is central to this — automated resupply triggers, depot-to-site allocation logic, and temperature excursion tracking reduce manual coordination burden and protect supply continuity.
Integrated with Clinical Operations
Sitero’s RTSM is part of the Mentor eClinical platform, which means supply management is integrated with EDC, eConsent, and real-time reporting under one system. For dose escalation programs, this integration ensures that dispensing records, patient enrollment data, and safety information are aligned — reducing the reconciliation work that accumulates when these functions are managed separately.
Frequently Asked Questions
Sitero’s RTSM supports configurable escalation scheme rules, including cohort size limits, dose transition criteria, and de-escalation triggers. Cohort transitions are executed through the system with full audit trail documentation, supporting dose escalation committee review without manual record reconstruction.
Yes. Sitero’s RTSM manages arm-specific supply allocation, depot inventory, and resupply logistics for multi-arm trials including basket and umbrella designs with parallel arms. Real-time inventory visibility prevents stockouts and expiry events across the global supply chain.
Sitero’s RTSM is designed to execute adaptive scheme changes — including arm drops, cohort expansions, and dose level modifications — with the audit trail and documentation required for regulatory review. Changes are implemented with appropriate controls to maintain protocol integrity.
