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IN PARTNERSHIP


moving the box into a temperature-controlled warehouse until customs clearance is done.


the best real-time visibility solutions on the market. Compared to other well-established visibility providers, Tec4med appreciates the feedback of small to mid-size companies and customises individual solutions for every client’s needs. With our strong background in software and cloud solutions, we adapt our software technology quickly to the client’s specific requirements and can connect data to any third-party platform. This way, Tec4med and iDEX got connected within only a few working days of the kick-off meeting, generating maximum value to TSafe’s and Tec4med’s clients.


Patrick, the client’s advantage is very clear, but how can you profit as an organisation? Is there any impact on the chain of custody and intrinsic quality? Patrick Rivera: TSafe benefits tremendously from the real-time data, getting live information of each shipment. This way, TSafe improves the control of the actual shipping status by tracking inside and outside temperature of the boxes, containers, or trucks. That means we can maintain a new level in quality because we’re in a position where we can always interact. Examples range from the correct storage


conditions of high-value clinical trial shipments within the temperature-controlled storage facilities of the airports to OTIF deliveries from our stations and hubs. Due to the close monitoring, we are now in the position to react almost in real time, preventing lane failure at its earliest point and offering a solution to stabilise the temperature. This could be a temperature-controlled vehicle for the last mile to prevent the box going out of range, an exchange with a new preconditioned box, or


Very interesting, Patrick, so what this means is it’s better quality for your clients through better monitoring tools? Patrick Rivera: Well, it’s far more than that. TSafe clients can profit from live tracking, as they can closely monitor their shipment for temperature, humidity, and shock. When shipping high-value materials such as API, intermediates or finished product, customers are reassured that everything is fine with their shipment already during the transportation. In any event of a delay during customs clearance or flight cancellations, the client – and we, of course – can check storage conditions to monitor the temperature for any needed action in case. And last but not least, for IMP shipments, a


more cost-effective solution is needed to stay competitive price wise – here, we go ahead with our semi-real-time solution. For the same price as a regular data logger, we use Tec4med’s SmartBeacons. These are Bluetooth loggers which can be easily read out with a smartphone app or PC, with immediate upload into the cloud once the device is connected to the internet. This enables the sponsor to release the drug for the patient without waiting up to 24 hours for the readout of the logger. Nico Höler: That’s right, Patrick, it is simple but very effective. While packing the shipment, the Tec4App helps to easily connect the beacon’s ID to the shipment ID. This way, at every checkpoint or handover of the shipment, the agent, consignee, or courier can simply scan the shipment label from the outside to read out the inside temperature of the parcel. Patrick Rivera: Even with this “light” solution, TSafe controls the cold chain whilst still delivering live data at any relevant checkpoint. Finally, the Tec4App enables the submission of photos and digital signatures on top of the primary data – temperature, shock, and humidity – submitting real-time footage of the shipment at every handover or delivery.


If you have any questions, please free to contact: Patrick Rivera, M.Sc. general manager, TSafe GmbH +49 6196 97290-55; patrick.rivera@tsafelogistics.com; tsafelogistics.com Nico Höler, M.Sc. CEO, Tec4med LifeScience GmbH +49 6151 36037-33; nico.holer@tec4med.com’ tec4med.com


Clinical Trial Supply Handbook | 69


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