Rave RTSM is the only fully pre-validated randomization and trial supply management solution that can be configured in minutes and enables mid-study changes with minimal downtime and no change orders.
RTSM is built on Rave EDC, so there is no double data entry and minimal reconciliation expediting study start-up and study-close out. Rave RTSM streamlines your operations and provides real-time visibility for your study teams.
Ease and Flexibility to Execute Direct-to-Patient (DtP) in Real-time
Rave RTSM has unsurpassed DtP capabilities giving sponsors and CROs the highest level of flexibility for decentralized and hybrid trials. DtP can be enabled for any combination of sites and visits and provides sites the ability to determine the source of the patient’s dispensation.
In addition, only the Medidata platform is truly virtualized allowing patients to confirm incoming shipments using the myMedidata App.
Robust Supply Management Tools
Rave RTSM’s supply management capabilities and real-time visibility provide the data and analysis to ensure supply optimization. RTSM’s supply plans offer the height of flexibility to make real-time decisions on supply planning. RTSM integrates with the industry’s largest depots, which ensures expedited shipping. Cross-study reporting, drug pooling and forecasting are just some examples of how to accomplish your supply chain objectives.
Mid-Study Changes with No Down Time or Change Orders
No need to stop enrollment or study activities. Rave RTSM’s pre-validated Edit Live Design™ is fast and easy to make mid-study changes to the randomization and dispensation designs and study visits without costly change orders and no down time for sites or users. Manage mid-study protocol amendments to enable sites or countries to be on different designs, while awaiting regulatory approval without stopping enrollment.
Supply Accountability Improves IP Workflow
Tracking IP across the lifecycle is easier than ever. Expedite the accountability process with real-time tracking on a single platform with designed workflows to ensure compliance and improved site satisfaction. Ensuring compliance while eliminating any painful regulatory audits. Shorten the duration from last patient visit to database lock with the unified solution of Rave EDC and Rave RTSM. Report the lifecycle of your study inventory from one source – the Medidata platform.
Build and Execute Complex Adaptive Trials Quickly and Efficiently
Rave RTSM has the flexibility to quickly and seamlessly adapt to changes in clinical trial designs using pre-validated randomization and trial supply solutions that can be configured in minutes. Complex adaptive, cohort, umbrella and basket trials are easier to build while mid-study changes can be made in minutes with no down time or change orders. Expedite study adaptations quicker across products on the Medidata platform.
Unparalleled Experience and Expertise in RTSM
Medidata’s Professional Services RTSM team of experts has countless years of clinical trial experience and a deep understanding of the IRT / RTSM industry. We partner with you every step of the way to ensure your RTSM processes are optimized so you can achieve the highest value. Support can range from full build and execution to Live Study Management™, which allows you to have an experienced IRT SME who plays the role of an unblinded supply manager during study conduct phase. Among the benefits where we guide you towards the most impactful supply strategy to meet your goals.
Reporting – A Single Source for your Clinical Trial Data
With MEDS Reporter, Supply, Study Managers and CRAs can access reports across multiple studies, as well as schedule and customize reusable reports. With more than 40 pre-validated RTSM reports for both blinded and unblinded users, study teams can ensure that they have the data they need to analyze efficient, transparent, and actionable reporting for their clinical trials.
MEDS Reporter is your single source to accurately monitor your clinical trials.
Benefits of Rave RTSM
Unification of Rave RTSM and Rave EDC
Rave RTSM is fully unified with Rave EDC with no customized integrations, no reconciliation required and is fully configurable and pre-validated. The Rave RTSM and EDC solution is a paradigm shift from IRT/EDC as separate vendor systems. Sites record patient visits in Rave EDC as Rave RTSM assigns randomization arms and inventory items in real time. There is no need for double entry which increases the overall data integrity and reduces risk.
Rave RTSM can be configured and implemented in as little as 2 weeks. Its pre-validated capabilities enable a quick UAT with reduced risk.
For mid-study changes, study builders can modify the study using RTSM’s state of the art Edit Live Design which enables changes to occur in real-time without stopping enrollment.
Robust Reporting and Analytics
Rave RTSM has extensive out-of-the-box reporting. This includes reports for both blinded and unblinded users. All reports can be scheduled or run ad hoc.
Only Medidata has cross-platform reporting which can be used to easily analyze study data. Trial and Supply Managers can leverage RTSM reporting to enhance efficiencies.
Shorten the Duration from LPI to Database Lock
Rave RTSM and Rave EDC are completely unified meaning there are no customized integrations reducing risk and timelines.
Data between RTSM and EDC requires no reconciliation as is required for a separate IRT and EDC model. This enables studies to lock much quicker, resulting in considerable cost savings.
Reduction of Risk
Rave RTSM is configurable and pre-validated. This means that RTSM works the same for all studies. What differs from one study to the next are the configuration settings of Randomization, Dispensation and Supply Management. With RTSM, User Acceptance Testing (UAT) is abbreviated with a smaller percentage of findings.
RTSM solution’s reduced risk is the biggest differentiator against all other IRT vendors.
myMedidata is a single-destination patient portal built on the industry’s leading Rave EDC, in use at more clinical research sites globally than any other system. With myMedidata, patients can use any online device to virtually learn, enroll and participate in clinical trial activities. This offers a streamlined and trusted approach to virtualizing clinical trials.
Medidata’s Rave EDC (Electronic Data Capture) is the most advanced, robust and secure EDC system for all clinical trial data capture and management. Rave EDC is the cornerstone of the Medidata Clinical Cloud® – the unified clinical research platform that connects processes, eliminates data reconciliation and delivers cross-functional and cross-study data insights.
MEDS Reporter provides cross-platform reporting for Supply and Study Managers who can access reports across multiple studies, as well as schedule and customize reusable reports. With more than 30 RTSM reports for both blinded and unblinded users, the data and analysis is at your fingertips to make real time decisions more efficiently.
Ready? Set. Go! Implementing Rave RTSM + EDC in 5 Weeks
The presenters will discuss how Southampton Clinical Trials Unit focused the implementation to achieve a “fit for purpose” deliverable while maximizing resource options to meet abbreviated timelines.
The team was faced with capturing large amounts of complex data as part of this trial when the outbreak of COVID-19 hit, necessitating an unprecedented turn around of deliverables.
Southampton Clinical Trials Unit Accelerates its Digital Transformation Journey
This case study explains how Southampton Clinical Trials Unit accelerated its digital transformation journey and Medidata provided support during the global pandemic.
Advantages of Pooled Supplies in Clinical Supplies
Investigational Drug (IP) manufacturing is expensive and can take long periods of time to complete. It is important to reduce waste, ensure efficient assignment of treatments, and reduce the administrative burden associated with tracking IP.
Drug pooling reduces drug supply overage and maintains adequate supplies for patients.