Veeva RTSM Resupply:
The Fundamentals and Beyond
Clinical trials with a large number of sites and dispensation visits have a higher need for thoughtful
resupply planning and automatic shipments. There is arguably correlation between the number ofsites, countries, depots, subjects, and visits and the importance of an effective trial supply
management solution.
An RTSM (randomization and trial supply management) system is not only purpose-built to meet therandomization requirements of a clinical trial but also the trial supply management needs. It should
offer a robust, regulatory-compliant option for generating and tracking shipments from depot to depot,
depot to site, site back to depot (returns), and even site-to-site transfers when required.
There are fundamental resupply capabilities that any successful RTSM solution should deliver:
1. ‘Static’ initial and resupply settings
2. Predictive resupply
3. Automated and manual requests
4. Low stock alerting
Veeva RTSM supports these fundamentals in the following ways:‘Static’ initial and resupply settings
Sometimes referred to as ‘trigger resupply’ or ‘buffer,’ these static numbers control what supply
to send to sites initially (at activation, screening, or first randomization, depending on design)
and when to trigger additional supply.

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In this example, for Site 102, 10 of each kit type will be sent initially. Subsequently, when the amountof either active or placebo reaches two, both kit types will be replenished up to six.
Permitted users have the flexibility to amend these settings on demand as we understandrecruitment plans may fluctuate.
It is typically recommended to maintain a level of buffer stock. This is to ensure that in the eventof any damaged/missing kits and any unscheduled resupply visits, the subject can be resupplied
and remain IP compliant. However, if recruitment has ended or supply is limited, this can be reduced
or even set to 0 and a predictive-only approach can be taken.

Predictive resupply
Predictive resupply in Veeva RTSM will take into account the ongoing patients at a site as well as
pre-determined site settings.
For example, ‘lead days’ will determine how long the shipment will take to reach the site. Triggerand target inventory days, sometimes referred to as short and long-range windows in the industry,
determine the time period to forecast.

These site-level settings, combined with the upcoming patient visits and the dispensation requiredat these visits, will determine how much additional supply to send to the site in addition to the staticsettings. This ensures that the supply needs of both new and existing patients are always met.

Automated and manual requests
The Veeva RTSM resupply algorithm runs daily or on demand and takes into account all site settingsto automatically generate required shipments.
Manual shipments can be raised ad-hoc by permitted users. For example, if a site has a sudden
spike in recruitment, it may be preferred to send a one-off additional shipment manually rather
than temporarily amend the site settings and back again.
Sites and depots can be set as static only, predictive, or manual on-demand throughout the study.

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Low stock alerting
Veeva RTSM generates low-stock alerts based on study-specific thresholds. This can provide early
warning that shipments are outstanding, that depot-to-depot shipments need to be initiated, or thata new manufacturing run may need to be considered for a trial.
Early detection can prevent patient-waiting situations on site or even study stock outages.

Going beyond the fundamentals
The above are examples of functionality that we believe all RTSM systems should provide.
However, there are features within Veeva RTSM that expand upon these and can provide significant
value to sponsors and supply management teams.

Partial dose prediction
In trials using titration, there can be many unknowns about whether patients will down-titrate,maintain, or up-titrate from visit to visit.
For example, at Visit 2 a subject on 10mg active may move to 5mg, maintain at 10mg or up titrate
to 15mg. There is a likelihood they will maintain, but there is a 10% chance of down titration and a
10% chance of up titration.
Veeva RTSM can support partial dose prediction, where the probability of different titrations can betaken into account in order to avoid overstocking for all scenarios as part of the predictive resupply.
This can maximize trial supply without putting subject visits at risk.

Resupply calculation visibility
Veeva RTSM provides a unique view into what calculation the system has applied to a site or ashipment. This visibility allows teams to easily understand why the system has or has not raised
a particular request without manual efforts and help desk inquiries.

Pre-allocation to subjects
Kits can be pre-allocated to subjects — within a shipment the kits can be associated with the subject
ID to ensure they can only be allocated to that specific subject. For example, this can be particularly
effective for cell/gene therapy study designs.
The ability to customize Veeva RTSM as well as configure allows any nuances with kit allocation tobe supported without the need for manual workarounds.

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Site-specific resupply settings
As part of static resupply, Veeva RTSM can support a set of resupply plans and defaults, for example
high, medium, low, and very low plans based on expected recruitment. These can then be applied toappropriate sites.
However, we also support the use of site-specific settings and a combination of plans and sitesettings. There is full flexibility for this to be as broad or as granular as required with minimum
configuration effort to tweak throughout the trial lifecycle.

Green light process integration
Connectivity between Veeva RTSM and Vault Clinical applications allows sponsors to utilize the green
light information in Vault CTMS/SSU to control site creation activation for shipping in Veeva RTSM.
This prevents the effort of duplicating site data entry and helps enforce regulatory compliance.

Service expertise
Resupply settings are of critical importance to the success of a study. Incorrect configuration
could under or overstock a site. Overstocking can cause expensive wastage and site inconvenience,but understocking can cause subjects to be lost from the study.
The priorities and needs of an individual trial design can be achieved through thoughtful
implementation and flexibility throughout study execution. Veeva RTSM provides an expert services
team throughout the entire study lifecycle to guide teams on all resupply options, best practices,and amendments.
We are happy to discuss both resupply fundamentals and beyond for any upcoming trial needs andcan demonstrate these different functionalities on request. This is not an exhaustive list of all trial
management capabilities, and we are happy to discuss further. Please contact info@rtsm.veeva.com
with your questions.

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