Overview
Personalized medicine trials don’t fit the standard RTSM software model. When every patient receives a custom-manufactured therapy, the supply chain logic that works for a conventional study stops working. A pioneering personalized medicine company running a global Phase I oncology trial had reached that limit with their existing RTSM provider. The system couldn’t adapt to what the trial required, and the trial was already live.
They brought in Korio to take over mid-study: migrating existing participant and supply data, building the integrations their trial design demanded, and doing it without disrupting a single patient’s treatment.
The Challenge
In a conventional clinical trial, the investigational product is manufactured in advance, distributed to sites, and administered to patients as needed. The RTSM manages inventory and supply logistics against a known quantity of drug. That model doesn’t translate to personalized medicine, where each patient’s therapy is manufactured individually and has to arrive at the right site at the right time for that specific patient.
Managing that kind of supply chain requires more than standard RTSM modules. It requires coordination across manufacturing, distribution, scheduling, lab assessments, and clinical sites, all running in parallel, all dependent on each other. The Sponsor’s existing provider couldn’t support that level of integration. The communication gap between the clinical and manufacturing supply chains had no solution within the platform they were using.
At the same time, the trial was already active. Participants were enrolled and being treated. Switching RTSM providers meant migrating existing participant data and in-flight supply records without creating gaps in the system of record, and without introducing any disruption at the site level. The outgoing provider had to be wound down at the same time the new platform came online.
The site experience added a further constraint. Despite the operational complexity sitting behind the system, the interface that site staff interacted with had to be straightforward. Sites managing multiple studies don’t have time to learn a complicated workflow. If the system required too much of them, compliance would suffer and patient treatment timelines would be at risk.
The Korio Approach
Building the integration the trial required
Standard RTSM platforms manage what is already known: inventory levels, shipment schedules, site allocations. This trial required something different. The Sponsor needed a system that could coordinate in real time across manufacturing, distribution, an EDC, scheduling, and diagnostics, bringing each of those data streams together to ensure that a participant’s custom therapy was available at the right site before their visit.
Korio integrated its platform into that ecosystem directly. The result was a just-in-time supply chain that gave both the Sponsor and site teams live visibility into where each participant’s therapy was in the process and whether it would be ready when needed. That transparency wasn’t just operationally useful. For a trial where losing track of a single participant’s treatment timeline could mean losing that participant, it was essential.
The site-facing interface was kept deliberately simple. The integrations and workflow logic running behind it were complex; what site staff saw was not. Korio’s RTSM guided users through the steps specific to their role without requiring them to understand the full operational picture.
Migrating a live trial without losing continuity
Taking over from a legacy RTSM mid-study meant working with data that was already in motion. Participant records, supply inventories, in-flight shipments: all of it had to be mapped, restructured, and migrated into the Korio platform accurately. Any gap in that data would have downstream consequences for participants who were actively being treated.
Korio managed the cutover so that the transition between systems was invisible at the site level. The outgoing provider was wound down as Korio came online. In-flight participants and supplies remained accounted for throughout. Post-go-live, Korio continued to support protocol amendments and further operational updates as the trial evolved.
Outcome
The trial continued without operational interruption through the migration and beyond. The Sponsor gained an RTSM platform that could actually support what their study required: coordinated supply chain management across multiple external systems, clear visibility for both Sponsor and site teams, and a site experience that didn’t add burden to an already complex protocol.
The solution also carried forward. Many of the features and workflows built for this trial are being adapted for the next phase of the study and for additional personalized medicine trials in the program. What was built to solve a specific problem became a reusable foundation, one that reduces setup time and maintains consistency in data collection and operational procedures across the program.
For a trial type that is becoming more common and for which standard RTSM platforms were not designed, that kind of reusability has direct value. The work doesn’t have to start over with each new study.