Patient Randomization and Clinical Trial Supply Management

Costly trial supplies – benefit from a range of advanced methods to reduce the supplies sent to site, from the recruitment phase to the last visit cycle.

Sourcing changes – change standard of care sourcing at both IMP and site levels, with automatic changes to site resupply strategy.

Disease progression – be assured that the system is designed from the start to manage additional participant visits.

Dose calculations – can be performed by the IRT if of value to sites, using any dose calculation and any formula.

Complex visit schedule – the system can be tailored to apply any protocol rules for switching between and restarting schedules.

Rescue medication – let RTSM mitigate the unknowns of treatment pause, including optimizing supplies and expiry management.

Novel randomization – from enrolment-only design to adaptive techniques, we are experts in approaches you can use to reduce the overall number of participants a rare disease trial requires.

Expensive and/or limited drug supply – use advanced methods to ensure only what’s needed is sent to site, including automatic site resupply tailored to recruitment rate and participants characteristics.

Long recruitment period – be assured by built-in self-service flexibility, customizable reporting, and ongoing dedicated support for the life of
the trial.

Challenging logistics – let the system manage tight controls on the participant-led supply chain, from manufacturing to time windows and expiry.

Fast-paced recruitment – easy-to-use recruitment controls with multi-level capping and site resupply tailored to manage a higher
risk of stock-out.

Seasonal recruitment – benefit from automatic site resupply tailored to the season, plus advanced expiry management controls to best
manage short shelf-life.

Short turnaround for design changes – we anticipate the need for fast adaptation with built-in flexibility to add new cohorts and doses.

Quality data needed promptly – rely on a system designed with data quality in mind, plus customizable reports and data sets to allow you to meet tight review timelines for cohort studies.

Sub-set randomization – can be effectively managed by RTSM, including randomization at the visit when data is needed to ensure drop-outs do not affect sub-set treatment balance.

Personalized drug manufacture – RTSM can support a complex and participant-led supply chain, including manufacturing slot and delivery verification, reserved medication, and personalized shipments.

Short time windows – let RTSM manage rapid timeframes, including time to participant administration and expiry management to the hour.

Complex visit management – RTSM can support personalized treatment plans, infusion volume calculations, and effective cross-team communication and alerting on upcoming events.

Innovative trial designs – rely on our experience of a range of innovative designs, including adaptive trials. Our support of master protocols includes a range of options for medication pooling, from the simple to the complex.

High risk of unblinding – we are experts at mitigating unblinding risk throughout the life of the trial, from randomization to site shipments to drug allocation to data provision. Our cross-functional SME team will deliver a tailored risk plan to ensure the additional unblinding risks of individualized treatment are properly managed.