Veeva RTSM Features Brief

Veeva RTSM is an enterprise standard randomization and trial supply management solution designed to accelerate study timelines and drive operational efficiencies. Guided by experts, Veeva RTSM is delivered by a dedicated services team with deep RTSM expertise, ensuring rapid implementation with precision.

Through flexible configuration options and appropriate customizations, Veeva RTSM tailors each study to meet protocol-specific requirements regardless of trial complexity. Seamless connections with the Veeva Clinical Platform and third-party integrations enable effortless adoption within existing clinical ecosystems.

Benefits

• Everything you need and only what you need: modular solution allows you to only use and pay for the functionality you need when you need it.
• No compromises: flexible configuration options combined with appropriate customizations achieves the design you want, not what your system provider limits you to.
• Maximize supply & minimize costs: adaptable trial supply management settings and expiry management to minimize drug wastage and control the schedule of site shipments.
• Exceptional service delivery: proactive project management, communication, and guidance from Veeva RTSM experts at every stage of your trial.

Randomization

Veeva RTSM ensures this critical transaction is completed with timeliness and precision.

• Multiple randomization schemas are available including static, stratified (single or multi-variable), dynamic/minimization, forced, and adaptive. Re-randomization is also supported.

• Easily configure eligibility, stratification, and other related questions to randomize subjects appropriately.

• Supports capping and can tightly control sentinel dosing.

Trial Supply Management

Define the optimal clinical trial supply management strategy for your trial’s needs.

• A range of methodologies to trigger site shipments including trigger/resupply thresholds, predictive inventory control and just in time options.

• Flexibility to adapt supply settings during study execution (e.g., change resupply levels based on actual site enrollment numbers).

• Track all types of clinical trial supply materials with blinded and unblinded views, temperature management options and connections with shipping providers.

• Supports complex patient dosing schedules including titration and dose probability.

• End to end drug accountability module tracing the full kit lifecycle.

Additional Features

Tracking Subject Activities

Easily track subject activities including scheduled activities such as screening and enrolling subjects; randomization, drug assignments including titration management, completion, and follow-up; unscheduled activities such as screen failure, early terminate/withdrawal, unscheduled resupply; skipped visits; and emergency unblinding.

Functionality for all trial types

Supports a variety of study designs including crossover studies, sequencing studies, extension studies, multi-cohort designs and sub-study tracking.

Rapid Setup Processes

Modular and highly configurable software enabling customers to achieve faster study set up timelines. The architecture also allows customizations to be engineered and deployed if required.

Easy Mid-study Updates

End users with appropriate permissions can easily reconfigure key settings during the course of a study — e.g., “turn on” a cohort, and modify allowable limits on total number of screened and randomized subjects. Amendments requiring a system design change can be implemented rapidly by the Veeva RTSM services team often in days rather than weeks.

Accessible Reporting

Intuitive filterable interfaces allow users to target what information they need to report on when they need it; review details on screen or export on demand to Excel and SAS.

User-friendly Interface

Simple easy to use interface with role and permission-based access. Purposely designed to minimize the number of clicks to complete common tasks and improve the accuracy of site data entry.

Connectivity

Veeva RTSM can function seamlessly with different electronic data capture systems, reporting tools and shipping providers.

Service Expertise

Veeva RTSM is delivered by a services team focused on customer success. The team has a deep understanding of RTSM best practices, system configuration and validation. During set up they work closely with customers to implement with speed and accuracy. Throughout trial execution the project manager and 24/7/365 help desk provide ongoing expertise and support.