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Support requests are scattered across emails and Teams. Nothing is tracked. No automatic notifications. No visibility on workload. Solutions are never documented, so the same questions are answered again and again
CSOS Support Request Tracking
Packaging lists are validated even when they are non-compliant. They need to be revised and revalidated. There is no harmonization, no standardization. It costs 148k€ extra in 2023 alone
Packaging List Optimization
unblinding cases happen but we want to enlarge unblinding people for emergency shipment
Blinding/Unblinding good practices
IRT setup is the top pain point in study setup — 40% of all identified challenges. The process is complex, requires high expertise, and involves too many stakeholders with unclear roles. Effort is duplicated and accountability is lost
IRT VSD
US patient volume is growing 40%. China is growing up to 100%. Political instability, wars, and logistics outages are increasing. We are not prepared to keep supplying kits to patients in these regions if something goes wrong
Resilience
FIH studies have multiple parts — healthy volunteers and patients. Each application works in isolation. Data is entered manually in multiple places. There is no single source of truth across the study platform
Veeva RTSM
In some double-blind studies, placebo kits are packed, shipped worldwide, and stored — only to be thrown away right after the IRT call. They are never used for treatment and are only needed for blinding matter. We waste money, storage, and carbon footprint for nothing
VKN (Virtual Kit Number)
Kits are locked to one study. If another study needs them urgently, the process to share them is heavy and slow. Kits sit unused in a depot while another study runs out
IP Pooling
Users spend significant time extracting data from IRT, generating reports, and doing manual tasks. You need expertise just to pull the right information. Multi-screen, multi-click processes slow everything down
SOFIA Suvoda
The on-premise SmartSupplies solution is reaching end-of-life. No new features. No future patches. Business continuity is at risk if we do not act
PMD to SaaS
Vaccine studies have IRT but cannot update with actuals in Pred App. Pharma studies use Supply App, but costs keep rising — 7.6M€ forecasted in 2026.
Lighthouse
When a patient moves from a parent study to a roll-over study, the Study Leader must manually customize each shipment — checking the previous treatment arm, the protocol, and the roll-over date. It takes time and creates risk
Roll Over Prediction
85% of pharma studies have IRT and represent 99% of CS activities. All studies get the same strategy, the same workload, the same cost — regardless of their complexity or importance. We cannot keep up with study acceleration this way
Segmentation
140+ live studies. A stock crisis takes 1 to 4 days to assess per study — 15 days for the whole portfolio. 90 people are involved in email chains. Patient visits are at risk. There is no automated solution on the market."
STORM
Buffer is managed manually, site by site. Kits expire and get replaced even when not needed. One shipment goes for buffer, another for prediction. Too many shipments, too much waste
Decimal Prediction