Customer Interview #1: Integra Clinical

SmartSense: What is your name and company?

Jessica: My name is Jessica Verdoza and I work for Integra clinical research.  I am a research assistant so I help in the lab and take the temperatures. I have been here since 2006.

Erica: My name is Erica Johnson and I am clinical site manager for Integra clinical.  I have been here for 1 year and 1 month.

SmartSense: What does Integra Clinical Research Specialize in?

Jessica: We specialize in multiple sclerosis, Alzheimer’s, and Parkinson’s trials.

Erica: Primarily we do neurological clinical trials. In the recent months we have expanded and done trials for in other areas such as diabetes and allergies.  Primarily we run trials for investigational drugs

SmartSense: Why did you choose our cellular device?

Erica: With what we do, a lot of the drugs we are testing in these trials the protocols and sponsors are trying to find out how the drug works and one of the components of that is how does it need to be stored.  When it comes out of the laboratory trials and we start to use them on human subjects, we know it needs to be refrigerated, but what temperature is going to put it in a place that isn’t effect.  These are still questions that the sponsor needs to know.  In order to maintain the quality of the data, all of our product has to be at a separate temperature at all times.  If it is refrigerated or in ambient room temperature, the drug needs to be in a certain range at all times.  What do you do on a Friday afternoon when the lights are off and you go home?  We need to know the drug is still at that temperature.  If the FDA comes in, we need to know that our product is safe for our patients.  This device allows us to do this when we are not physically here.

SmartSense: How are you using the device? Using it in refrigerator or storage room?

Erica: Both.  We have one in our refrigerator and one in our storage room.  We are anxiously awaiting to test the new model with the new ranges for our drugs.

SmartSense: Was it difficult to setup?

Erica: Not at all.  It took 5 minutes.

SmartSense: How did you find out about SmartSense and why did you choose us?

Erica: One of our coordinators had a contact and was contacted by the company who said we had a prototype.  We were willing to partake in the prototype and eventually purchased the models when it became an actual project.  We recently moved during the summer to a new facility, and my first priority was getting the device set up for the new location.  We had to make sure to come in ahead of time to set it up prior to the drugs being transported.

SmartSense: Have you received any alerts and how did you respond?

Erica: Yes we have.  During the move, we just put it in the room and the construction company was working on getting the temperature balanced in the room.  The alert went off and I made quick phone calls to figure out exactly what happened.  The construction guys were tweaking with the A/C unit.  On another occasion, while we were in a meeting, the device went off due to a power surge.  Luckily, nothing was out of range for more than 10 seconds but we were alerted to figure out what exactly went on.

SmartSense: From a research standpoint, how is temperature important to you?

Jessica: It is important to keep it in range because of the safety of our patients.  We need to keep it in range to insure the safety of our drugs.

SmartSense: Who determines the range of the drugs?

Jessica: The sponsors tell us the exact range for the drugs.

TempAlert: What was your worry level about the temperature pre and post purchase of our device?

Erica: Before your device, it was a great concern to us. As the site manager, I needed to identify weaknesses.  The largest weakness I found was not having an alarm for changes in temperature.  I felt that we had to have this and your device definitely fixed it.  I did some research, but did not have to go through months and months of research.  Your support team walked us all through the device and the setup and we felt really comfortable with your device.