For Data Managers, CRAs, and Clinical Operations professionals, decentralized clinical trials represent a significant transformation in study management.
The Direct-to-Patient (DTP) model enables investigational of medicinal products (IMPs) to be delivered directly to participants’ homes, reducing unnecessary site visits and improving the patient experience.
With ACTide RTSM, sponsors can centrally coordinate supply chain operations, randomization, and IMP management, increasing efficiency, control, and regulatory compliance throughout the study lifecycle.
What is the DTP model?
The Direct-to-Patient model involves shipping the IMP directly to the participant’s home, eliminating or reducing the need for frequent visits to the clinical site.
According to FDA and EMA guidelines on decentralized clinical trials, this approach requires rigorous procedures to ensure sample integrity, data privacy, and delivery traceability.
When should you choose the DTP model?
- long-term studies: Reduces the frequency of on-site visits.
- Chronic and rare diseases: Reaches geographically dispersed patients or those with limited mobility.
- Multicenter trials: Coordinates shipments across multiple countries from a single ACTide RTSM platform.
- Oncology protocols: Manages complex dosing regimens with timely IMP distribution.
- Post-treatment follow-up: Keeps patients engaged in the study without requiring site access.
Discover how ACTide RTSM supports the Direct-to-Patient model.
Operational and regulatory challenges of DTP
For Data Managers and CRAs, decentralized clinical trials introduce complexities that go far beyond simply shipping medication to a patient’s home.
The cold chain must be monitored throughout the entire transportation process, while identity separation requires that couriers have no access to any patient clinical information. Additional challenges include complete IMP traceability from the pharmacy to the participant’s home, controlled management of returns, deviations, or damaged products, and the risk of overstocking caused by manual or inflexible logistics planning, which can lead to avoidable waste and costs.
EMA guidelines for decentralized trials also emphasize the need for reliable electronic systems to ensure data integrity. ACTide RTSM supports sponsors and clinical sites with automated workflows, real-time audit trails, and continuous visibility across the entire supply chain.
Learn how to ensure complete data traceability with “Audit Trails and GCP Compliance: How to Ensure Complete Data Traceability.”
The solution: ACTide’s smart RTSM
ACTide RTSM is designed to support the growing complexity of decentralized clinical trials and Direct-to-Patient models. The platform centralizes and automates critical logistics processes, integrates with the study’s technology ecosystem, and ensures compliance with FDA 21 CFR Part 11 and EU Annex 11.
What ACTide RTSM does for your DTP trial:
- predictive algorithms: Automatic dose calculations and just-in-time resupply.
- Repository management: Coordination of local depots to minimize delivery times.
- Home delivery management: End-to-end coordination with real-time tracking.
- Data segregation: A system that separates clinical data from logistics information.
- Monitoring dashboards: Real-time visibility into every IMP, wherever it is.
Want to reduce the operational complexity of Direct-to-Patient processes?
Request an ACTide demo and discover how to automate IMP management.
Benefits for clinical studies
Adopting a Direct-to-Patient model supported by ACTide RTSM delivers tangible benefits for both participants and study teams.
Greater convenience for patients and fewer in-person visits improve protocol compliance and directly contribute to lower dropout rates. At the same time, predictive resupply strategies and more precise supply chain management help optimize IMP management costs by reducing waste and inefficiencies associated with static planning.
Finally, automating logistics and operational processes significantly reduces the administrative burden on clinical site staff, allowing CRAs and Data Managers to focus on higher-value activities and data quality oversight.
Discover how digital patient engagement contributes to increased retention in clinical trials.
Start your Direct-to-Patient trial with ACTide today
Decentralized clinical trials are no longer an experiment, they are becoming the new standard for more efficient, patient-centric studies that fully comply with international regulations.
However, the Direct-to-Patient model requires an RTSM platform capable of managing the growing operational complexity of supply chain activities and IMP logistics.
ACTide RTSM is designed to support every stage of the study, from randomization to home delivery, ensuring process automation, end-to-end traceability, and full regulatory compliance.
Are you planning a decentralized trial or transitioning to a Direct-to-Patient model?
Discover how ACTide RTSM can make your logistics smarter and more secure.