Streamlined randomization meets optimized supply management
Randomization & Trial Supply Management
Make your clinical supplies go further
Reduce overage requirements
Direct medication only to where the study needs it, limiting wastage and reducing overage needs, using our proprietary algorithms
Save medication across study programs
Pool supplies across studies to further optimize medication supply requirements
Enable direct-to-patient clinical supplies
Deliver medication to patients at-home with full oversight and tracking
Empower end users
Provide access to key reports and visibility into study KPIs powered by a modern interface
Optimize medication expiry
Ship and dispense medication to optimize shelf life
Understand ongoing study supply needs
Plan mid-study production based on accurate study usage data
How does RTSM improve efficiency?
Signant SmartSignals Randomization and Trial Supply Management (RTSM) addresses the logistical complexities inherent in patient randomization and investigational product management by streamlining and condensing processes.
DESIGN
Configurable checklists allow you to skip duplicative design calls and source document reviews, and you can visualize your system during configuration.
IMPLEMENT
Deploy your RTSM system in 1-4 weeks after kickoff using Signant’s agile, iterative design process that handles even the most complex randomization schemes and dosing schedules.
MANAGE
Handle mid-study changes with ease using the same optimized design process, and lean on support from a dedicated project team and 24/7 helpdesk from system build to study close.
Industry leading configurable RTSM platform
Signant SmartSignals RTSM effectively manages randomization and optimizes the trial supply chain to reduce waste and guarantee that the right patients get the right products at the right time. We are ready to support your traditional, virtual, or hybrid trials with a direct-to-patient model of clinical supply delivery and management to give you the visibility and control regardless of protocol design, randomization schemes, or other complex requirements.
Why choose Signant SmartSignals?
Signant SmartSignals RTSM is a trusted and foundational component to any study, relied on by top sponsors and CROs as the only platform that offers a single source for:
Rapid deployment
Signant’s streamlined design/build approach allows us to fully implement RTSM twice as fast – one to four weeks compared to eight weeks or more with other solutions, and this same process is applied to protocol amendments to quickly accommodate mid-study changes.
Integration
RTSM seamlessly blends with Signant’s end-to-end evidence generation and clinical trial management solutions including eCOA and clinical supplies management as well as with third parties for electronic data capture and manufacturing solutions.
Enable direct-to-patient medication provision
Simplify trial participation by including flexible decentralized elements. Signant SmartSignals RTSM solves the challenges of direct-to-patient medication provision by enabling at home medication provision, securely managing patient addresses, and integrating with leading clinical supply distribution partners to provide at-home delivery with full visibility to sites and patients. Our solution even provides the flexibility to choose between at-site and at-home medication provision at different visits, and to accommodate different country regulations and site preferences.
Clinical and operational support
Not technology for technology’s sake, Signant’s RTSM solution provides the mobile apps, user-focused features, and product support you expect as well as guidance from our clinical science, biostatistical, project management, and business intelligence experts who shepherd your RTSM deployment from inception to system archival.
Robust API offerings
Enhance efficiency and data management with our library of RTSM APIs which provide near real-time data access for analytics, integrations, and reporting. These APIs ensure standardized, study-agnostic data flow, improving overall study management and decision-making.
Efficient audit trail reporting
Choose SmartSignals RTSM for efficient data release management. It automates data packaging for secure, role-based access by authorized recipients. Enjoy controlled access, traceability, and quick release of full data sets at any study point. Easily generate datasets and audit trail reports on-demand or self-service.
FAQs
What is RTSM in clinical trials?
RTSM stands for randomization and trial supply management. It refers to a technology solution used in clinical trials to control patient randomization and manage drug dispensation. Industry also refers to it as IRT, IVRS, or IWRS.
What is the purpose of randomization in clinical trials?
Randomization is a method of experimental control that prevents selection or accidental bias. Randomization forms the basis for statistical tests.
What is clinical trial supply management?
Clinical trial supply management is typically a computer-controlled system used in clinical trials to dispense and manage site inventories.
Can Randomization & Trial System Management be accessed on a mobile device?
With Signant’s SmartSignals RTSM solution, mobile applications are available through both Apple and Google stores. If your study is set up for mobile access, you may log in with the same credentials you used on the web.
Can I use Signant’s Randomization & Trial System Management system to unblind a subject?
For double blind trials, our RTSM solution enables a function for authorized users to unblind a patient in an emergency. The user manual and/or study monitor can provide additional guidance.
How do I fix a data entry error in the system?
The DCF may be found on the landing page upon log in, or please contact the Helpdesk for additional support.
Leverage Signant’s experience
With Signant’s RTSM, you leverage over 20 years of experience implementing more than 2000 protocols in 90 countries. Count on Signant’s full-service RTSM to lay the operational groundwork your study needs to effectively generate evidence.