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Accelerated Digitalization?

Accelerated Digitalization?

The increasing number of clinical trials and the need for more efficiency, higher safety and compliance drive accelerated digitalization.

Harald van Weeren is Segment Manager for Clinical Trial at Berlinger Co. AG. Berlinger Co. AG is a Swiss based company specialized in high-quality temperature monitoring solutions for pharmaceutical goods and medical products. In May 2020 he held a webinar about digitalization in the temperature-monitoring process for clinical trials and shares his experience about the output of the webinar.

A few weeks ago, I had the opportunity to present the webinar on “Digitalized Temperature-Monitoring Solution for Clinical Trials”. The core topic is how digitalization of temperature monitoring of drug-kits can make life in clinical supply easier, more efficient, safer and how it can support compliance and reduce cost.

In all honesty, the idea of a webinar was born because many physical conferences had been cancelled due to the pandemic, and just like many others we had to go digital. Despite the short period of time, the reach has been amazing – over 100 people were listening in from the US to Australia. Of course, I am stating the obvious that digitalization is all around us, but the above example shows once more that digitalization helps to make our processes more efficient. It has a tremendous impact on communication and even helps to keep the world turning during a pandemic.

The increasing number of clinical trials and the need for more efficiency, higher safety and compliance drive accelerated digitalization. Now, this is further amplified given the number of trials for COVID-19 vaccines on top of the already existing clinical trials. When it comes to digitalization of temperature monitoring solutions in clinical trials, the results of the poll questions during the webinar further support the above observation: a whopping 53% of the respondents feel that efficiency and safety can be increased by digitalization, by removing error prone and time-consuming manual handling. Looking further into the future, 42% of the respondents feel that digitalization can improve efficiency by prediction of logistics performance. To sum up, digitalization is indeed everywhere, and it is accelerating.

Before I wave off, I owe the listeners some answers to questions I was unable to discuss during the webinar:

Question 1: What is the maximum number of days that the temperature monitoring can record, before the battery runs out and data can’t be recorded?

Answer 1: This depends on the device, but generally between 2 and 3 years.

Question 2: Can SmartView track drug kit temperatures during clinical site storage (non-shipment excursions)?

Answer 2: Yes, absolutely and it is vital to do so since drug-kit stability is determined from beginning to end, including clinical site storage.

Question 3: Which IRT systems does SmartView work with or is SmartView also an IRT

Answer 3: Berlinger works with several IRT vendors and it must be clear that SmartView is NOT an IRT. SmartView focusses on the temperature analytics and the IRT knows which drug-kit is associated with which logger. SmartView and the IRT will make the puzzle for a complete end-to-end view of the temperature profile and related stability.

Webinar outlook: Berlinger is keen to  follow up soon with another webinar, where participants will learn more about “Digitalized Temperature-Monitoring Solution for Clinical Trials”. We will keep you posted.

Berlinger Co. AG Harald van Weeren

Segment Manager Clinical Trials