Founded in 2006 by CEO and senior principal advisor Helene Quie, Qmed Consulting A/S (Qmed) is a full-service, ISO 9001- and ISO 14155-certified medical device Contract Research Organization (CRO) and consultancy. Headquartered in Copenhagen, the company aims to facilitate the approval of innovative medical devices and medicinal products, streamlining healthcare processes and enhancing patient well-being.
“Qmed started as a consultancy, writing clinical evaluations,” explains Helene, who has a background as a cell biologist and has worked with devices since the mid-nineties. “We took available data, put it into a report, and concluded if the medical device was safe and if it performed. And then the company grew from there—from two people to four. Now, we are 35 people, and we include a full-service CRO.”
Data manager Mette Flindt joined Qmed in 2023. She has gained extensive clinical document and data management experience in the pharmaceutical industry over the past 20 years. She has worked with most aspects of clinical data management: eCRF design, setting up the database using CDISC standards, data collection, data validation, preparing documents, query handling, SAE reconciliation, and STDM annotation.
“Qmed is the first company I have worked at that works with medical devices. And I have to say I love it. No two days are alike,” explains Mette.
Over the past decade and a half, Qmed has gone from strength to strength. The team in Copenhagen started out doing relatively small studies to running extensive studies with 800-900 patients worldwide. They even have employees throughout Europe and subcontractors in other regions supporting their work.
Before the widespread adoption of Electronic Data Capture (EDC), organizations like Qmed used a significant amount of paper. Reasons for this include the strict requirements for documenting and reporting clinical trial data by regulatory agencies like the FDA or the EMA. Researchers, site staff, and CROs were accustomed to documenting, collecting, and managing data on physical forms.
However, as technology improved, regulatory agencies began to encourage and support the adoption of EDC, and the benefits of electronic data capture became more apparent. EDC offered advantages such as faster data collection, reduced data entry errors, real-time monitoring, more accessible data sharing, and enhanced security. These advantages ultimately drove the widespread adoption of EDC in clinical research, reducing paper-based processes and the associated costs and inefficiencies.
Then, a shift began. Qmed and the industry were leaving behind paper-based processes, with companies like Viedoc leading the way.
“Our objective is to get the right data out of the study, put it together correctly, and then tell people that a medical device works, is safe, and can change people’s lives for the better,” says Helene. “We used to work with paper, but now it’s all on the computer. We need EDC systems now to run our studies.”
She reflects on the past, “I remember those days when EDC systems didn't exist; we had papers with three carbon copies and a huge suitcase for monitoring—carried around on a trolley on wheels!”
“At Qmed, we have always tried not to stick to one system but to find systems suitable for the different trials we conduct,” says Helene. “One might be better for a 10-patient trial or one with 50 patients or 800 patients. We found that Viedoc is a very flexible, easy, user-friendly system. Using Viedoc, we can build studies and get a nice set of reports,” she adds. “Viedoc is a rock-solid system with good standard reports; you can still adapt it. So, there is that flexibility and that I like.”
Mette agrees. “Viedoc is a safe choice. It meets all the requirements, is very flexible and affordable, and has a nice look. It's very user-friendly—especially the ePRO (Viedoc Me), the trial master file (Viedoc TMF), and for the end users.”
Mette has worked on and off with Viedoc for about five years and appreciates the opportunity to continually learn new skills. “eLearning is unique for Viedoc. Not many systems have that. It is good with the certificate and the whole user-creation process. You can see right away that users are trained, and you can grant them access to the system. In 2020, I took the study-build course, so now I can also build myself.”
The Viedoc Study Build Training program is available to all organizations that wish to build their studies in Viedoc. Upon successful completion, participants attain certification as Viedoc Designers, enabling them to construct studies within the Viedoc Designer platform autonomously. This training program is conducted virtually, with participants gaining proficiency in building studies, crafting forms, and configuring checks using the Viedoc platform.
The Qmed team is busy preparing for its next study—a medical device to be used for patients with serious heart conditions. Neither Helene nor Mette can say too much at this stage, but they share that the upcoming study is in the UAT phase.
Helene explains: “It's a relatively large study, and I think that's where the training part is important—like what Mette mentioned about eLearning. Ours is a multicenter study, with a site in Europe and one in an Asian country. Many stakeholders are involved, so Viedoc's flexibility, especially in the training and the eLearning, comes out as important when we want to go live and start including patients.”
“We picked Viedoc because the flexibility and the reporting fit the client's needs and the price. And the Viedoc staff showed that they were flexible too—they attended the kick-off meeting with the client with very short notice,” explains Helene.
She continues: “The Viedoc team reacts quickly to requests and shows up, and they are present and not difficult to get a hold of. That's very important, especially for clients starting an extensive study that costs a fortune. They want to see that it progresses without wasting any time!”
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