Digitalized Monitoring Solution for Clinical Trials

Berlinger as first mover in the market

COST- AND TIME-INTENSIVE DUE TO MANUAL HANDLING

Clinical Trials need a digitalized monitoring solution

Today’s temperature monitoring in clinical trials is time- and cost-intensive. Data is entered and collected manually and is error-prone. This leads to limited transparency and missing information during the clinical trial process and long decision-making processes. As a result of this, the patient has to be rescheduled or is even lost for the Clinical Trial Kit.
1.

Site Monitoring Solution (Depot -IRT)

The key of the SmartView Clinical Trial Solution is to provide a full cumulative, end-to-end temperature profile for each drug kit. Building up the temperature history starts at the depot. At this stage, the temperature logger is associated with the drug kit by the IRT. The recorded temperature profile for each drug kit is being uploaded to the IRT and exchanged with Berlinger SmartView. Excursions and to what extent the stability budget is being consumed is recorded and the responsible person (e.g. QP) can be notified instantly.
FROM FIRST SHIPMENT TO LAST FRIDGE

Berlinger SmartView is a fully integrated monitoring solution

1st Step

Initial Clinical trial temperature monitoring set up

- Interface between your IRT and Berlinger SmartView is programmed
- Clinical trial is setup in both IRT and SmartView
2nd Step

Depot Monitoring

- Drug kits are associated with the device (e.g. a Fridge-tag) at the depot (every single drug kit is profiled)
- SmartView informs IRT if product stability budget has been breached
3rd Step

Depot to Site

- IRT creates shipment order
- Shipment is fulfilled by depot
4th Step

Shipment arrives at Site

- Site uses IRT for Incoming Goods Inspection
- Drug kits are associated with the site monitoring device e.g. hospital pharmacy refrigerator
- IRT receives warning from SmartView if product stability budget has been breached
5th Step

Calculate product stability data

- Drug kits are stored at site before dispensing to patient
6th Step

Quality assessment

- IRT is "front face" for managing drug kit supply chain
- IRT used to record "dispatch drug kit to patient" or "put drug kit in quarantine"
- For quality assessments e.g. as in quarantined drug kit workflows, SmartView can be used as an additional tool
7. Step

Analytics

- View where excursions occurred and analyze impact
- Decide if product can be used
- Reports can be downloaded and inspected e.g. per drug kit
- Other tools available such as shipment analytics, root cause registration of excursion, audit trails
Save up to seven-digit figures

The Success

Process optimization, quality improvement and higher safety Investment into SmartView Clinical Trial can save up to