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FGKis a full-service clinical research organization (CRO) that specializes in small biotech and MedTech companies, offering flat hierarchies, flexible solutions, and customized services. Starting as a small private company in 2002, FGK grew organically as the demand for dynamic quality solutions that make a real difference for patients has driven its growth over two decades.
To learn how Viedoc’s platform has allowed FGK to develop into the powerhouse it is today, we met with Martin Krauss, their co-founder and managing director, Anneke Neuhaus, director of eSolutions, and Ursula Türcke, senior director of clinical operations.
FGK has been consistent in its vision and specialization—providing flexible, independent, and specialized services to niche clientele. Small biotech companies and small development groups in medical device companies do not have solutions for every issue like big pharmaceutical companies. Therefore, they need the personalized consultancy and support that FGK delivers throughout each study.
Today, FGK does 40 to 50 full-service studies a year, and every study has a different lifespan, timeline, and range of services. Their main territory is Europe, but the possibility of acting in different regions outside Europe is on the table.
- We really want to support biotech and medical device companies, to develop their products and their inventions, and to bring better solutions to the patients. The quality of our team is based on this basic thinking. More than 90 percent of staff members have an academic degree. They are scientists and they want to make a difference in life, and they want to bring their whole expertise and energy to their work. And that makes for a very motivated team spirit here.
Viedoc came into the picture at FGK back in 2013-2014, when FGK took over a study from a small Austrian biotech company that worked with Viedoc. Today, FGK chooses Viedoc to run a majority of their studies, and we asked Anneke to explain why.
- With Viedoc, we have the whole process in our hands, which is very important. From the first steps in design until deployment to the production environment, we do not need to interact with customer support teams to deploy our study. We can do everything by ourselves. We are completely independent and can launch a study whenever we would like to and whenever we are ready to do so. This is one very important aspect for us, and for our clients.
The Viedoc system offers a lot of capabilities that FGK requires. Their eSolution teams, eSolutions manager, and data managers bring knowledge and experience to clinical trials, which provides an excellent basis for setting up complex studies with complex requirements that both their biotech clients and medical device clients have. With Viedoc, it’s very easy for them to integrate modules like randomization in studies, and users do not have to switch systems. Furthermore, the ePRO set up with Viedoc Me is very easy and convenient for teams and front-end users. Ursula explains how this benefits the whole company.
- We have control over the timeline, so we can communicate. This change can be done within five days, and we don't have to ask a third party, “How long will it take for this change to be implemented? And will you have resources to do it in the announced timeline?” So, it makes us much more reliable and more confident, also with regards to what we communicate to our clients.
Working as a people’s business
- This is a people's business. Even though the product is an electronic system or platform, the people and the expertise behind it make the difference and can give the extra benefit.
It’s because of this attitude that Martin and the team at FGK are excited about Viedoc.
- There is a personal commitment from the Viedoc team. They really care about their product and about customer satisfaction. Clinical development is complex, it's difficult. There are always issues, it's never easy. And then having someone there who is responsible and cares about the issues, that's so important for us in our team, but also for our cooperative partners.
According to Martin and Ursula, Viedoc always listens. FGK has noticed that Viedoc takes a real interest in understanding their needs, but also the needs of their clients. Viedoc considers these points in product development so that new features not only make the product better but also make sense for the clients. This is unique, as most systems available on the market are provided as a finished product with little room for modifications. That’s what sets Viedoc apart—innovation with the client in mind.
Connecting everyone with one platform
As director of eSolutions, Anneke runs a 13-person department including eSolution managers and senior eSolution managers. One group focuses on the eCRF's and RTSM modules, and the other focuses on eTMF and Clinical Trial Management System (CTMS).
The site staff are the front-line users of Viedoc because they enter the data, but many other departments work within the Viedoc system as well, including the clinical research associates (CRAs), the data management team, and project management. When Viedoc Me is incorporated, the subjects can also access the platform. Sponsors, too, can have full access to the data in Viedoc. Understandably, ease of use is fundamental to Viedoc’s value, and the feedback FGK receives, from the CRAs and data management teams to the users at sites, is that Viedoc’s software is straightforward to implement and simple to use.
Ursula elaborates.
- Interactivity is a very important aspect. The possibility to adjust to the specific project’s specifications is very important for us because every project has different challenges. Sometimes there are several aspects that have to be considered and no study is like the other. That requires a flexible system with different modules and different possibilities but also know-how and expertise of the people behind those systems.
Looking ahead with FGK
We asked Martin, Ursula, and Anneke to enlighten us on what they see happening to clinical trials in the future. Martin expects further innovations with patients at the forefront, like decentralized clinical trials.
- The interactions with the different technical systems, the interfaces, and the use of data beyond the clinical data that we have—this will come up and will change or evolve how we are conducting clinical trials. But it will still be a people's business. It’s really important that the people behind it have the right attitude, and the right background and training and philosophy to do that in a successful way.
We also asked Ursula for her perspective.
- I would focus more on the near future. What we see more and more is five projects combined in one study really requires complex electronic solutions and complex thinking, especially in the set-up stage. I think this will also be important—that systems can adapt to those needs and can really provide the benefit to those requirements and to this complexity.
Anneke agrees with Ursula and Martin, and stresses that trials will only become more complex.
- I think you can never stop developing, and if you start to relax too much, then you’re losing contact with what’s really going on out there.
As both FGK and Viedoc look to the future, it’s clear what will push their innovation forward: their clients’ needs.
