Patient-specific manufacturing slots, chain of identity and custody, cryogenic shipping, and follow-up that runs for years. Our RTSM technology and experts are built to hold that complexity, from first participant in to database lock.
30 years of RTSM experience, applied to the scheduling and traceability demands of cell and gene therapy.
The products and expertise we bring to cell and gene therapy trials, from small-cohort randomization and cryogenic supply through to eCOA and study-design consultancy.
Solutions
Our next-generation unified RTSM / IRT platform. Randomization, participant management, inventory, supply, and reporting in one connected system, designed to support the scheduling and traceability that patient-specific therapies demand.
Learn MoreStreamlined, ready-to-deploy RTSM on the same platform and quality framework, with go-live in about four weeks. A right-fit option for biotech-sponsored, early-phase cell and gene therapy studies that need proven capability fast.
Learn MoreElectronic Clinical Outcome Assessment through our Kayentis partnership, available as an integrated RTSM plus eCOA solution to capture patient-reported outcomes across long follow-up periods alongside randomization and dosing.
Learn MoreSupply-chain and randomization consultancy plus expert training, designed to de-risk single-arm and small-cohort cell and gene therapy designs before and during the study.
Learn MoreServices
End-to-end RTSM design, implementation, integration, validation, deployment, and support for cell and gene therapy protocols, delivered by an embedded team of experts.
Learn MoreExpert design of randomization and stratification strategy for small-cohort, single-arm, and open-label cell and gene therapy protocols.
Learn MoreForecasting and supply modeling to protect continuity of high-value, cryopreserved, and short-shelf-life IMP.
Learn MoreThe four capability areas behind every study we run, applied to the specific demands of cell and gene therapy clinical trials.
Blocked, stratified, and dynamic randomization for small-cohort, open-label, and single-arm cell and gene therapy protocols.
Shipment tracking, depot-to-site logistics, and lot and expiry management for cryopreserved autologous and allogeneic product.
Visit scheduling from apheresis to infusion, participant replacement, and site management across long-term follow-up periods.
Audit trails, data-change reporting, and real-time dashboards designed to support inspection readiness for cell and gene therapy submissions.
A look at how standardized configurations and expert support shortened study start-up — and what teams running Phase II and III trials can take from it.
July 24, 2026
Talk with our RTSM experts about the scheduling, supply, and data challenges specific to your cell or gene therapy protocol.
