Direct-to-Patient Drug Supply Management

S-CLINICA's Direct-to-Patient (DtP) Drug Supply Management module is a specialist clinical trial software solution supported by Interactive Response Technology (IRT), designed to meet the growing demands of complex, patient-centric clinical studies. As the pharmaceutical industry increasingly focuses on rare and orphan indications, personalised medicine, and adaptive trial designs, the volume and complexity of patient and trial data has grown substantially. S-CLINICA addresses these challenges through automation and technology, drawing on over 27 years of deep domain expertise in IRT systems and drug supply management for innovative pharma and biotech clients.

With clinical trials becoming more virtual and hybrid in nature, and with greater use of electronic patient reported outcomes (ePRO) collected via patients' own devices, direct-to-patient drug shipping has become an essential capability. The DtP module enables sponsors to reach more diverse patient populations — including those who are unable or unwilling to travel to clinical sites — while maintaining data integrity and operational control throughout the supply chain.

Key Capabilities of the DtP Drug Supply Management Module

• Unblinding scenario management: The system accounts for unblinding scenarios to protect trial integrity throughout the drug supply process.
• Patient privacy: Built-in mechanisms maintain patient confidentiality across all direct-to-patient interactions and shipments.
• Temperature deviation handling: The platform is equipped to manage and respond to temperature excursions that may occur during direct shipments.
• Just-in-time labelling: Labelling requirements for just-in-time delivery are fully supported, ensuring compliance at the point of dispatch.
• Individual patient flexibility: The solution is flexible enough to accommodate unique challenges faced by individual patients, reflecting the diverse needs of modern trial populations.
• Drug accountability and destruction: Full drug accountability tracking and drug destruction workflows are performed within the platform.
• Flexible supply modelling: The system supports a range of supply models, including traditional site-to-patient shipments and direct-to-patient shipments, or a combination of both.
• Patient training: The module includes support for patient training, ensuring participants are equipped to manage their study medication correctly.

IRT Platform and Supply Forecasting Integration

• The S-CLINICA platform includes the ClinVision supply forecasting module, which can forecast demand across a mix of traditional site-based and direct-to-patient shipment models.
• Once a study is live, the IRT platform manages patient interactions and drug supplies, performing a range of functions for sponsors, drug depots, and clinical sites.
• The IRT system provides greater visibility into drug stock levels and frequently integrates with warehouse return systems for end-to-end supply chain oversight.
• The combined IRT and drug supply solution is designed to anticipate a trial's supply needs, keep trial data clean, and accommodate complex and adaptive study designs.

Broader Platform Modules

• ClinVision — clinical supply forecasting
• RTSM — randomisation and trial supply management
• Personalised Medicine — support for individualised treatment protocols
• Drug & Supplies Management — comprehensive inventory and supply tools
• Supplies Return & Destruction — end-of-study returns management
• Data Transfer & Integrations — connectivity with external systems and data sources
• IRT in Veterinary Clinical Trials — specialised IRT capabilities for veterinary studies

S-CLINICA's DtP Drug Supply Management solution is delivered as part of an integrated clinical trial technology platform, with integration capabilities to warehouse and return systems. The platform is built to support sponsors navigating the operational complexity of modern clinical trials, offering a trusted technology partnership backed by nearly three decades of specialist experience in IRT and drug supply management.