Lör 20 jul / År 42 / Nr 3 2024

Organic growth to support developing biotech and medtech

FGK Clinical Research is a full-service contract research organisation based in Munich, in Germany. Over the 16 years since it was founded, the company has grown, with subsidiaries in the Czech Republic, the UK, Hungary and Poland. FGK has over 110 employees, and its focus is on working with small and mid-size biotech, pharma and medtech companies.

In the fast-moving drug and medical device industry, innovation is very important. The pioneering approaches come from small- and medium-sized companies, but it’s a challenge for these companies to develop products through to the market alone. This is where FGK Clinical Research plays its role, providing support as a full-service contract research organisation.
”Our focus is on working with the smaller clients,” said Martin Krauss, Managing Director of FGK Clinical Research. ”These are smart and innovative, and need excellent support and a lot of flexibility.”

Services driven by experience
Because FGK has a number of subsidiaries across Europe, and over a hundred employees, it is big enough to provide a range of services, and small enough to remain flexible and tailor its offerings to its clients’ needs. FGK has experience in a wide variety of key areas including oncology, central nervous system disorders, dermatology, and cardiovascular disease, but works beyond these specialist fields. In addition, completely new approaches such as advanced therapies, including cell therapies and genetic modification, are well known to the company.
”Our knowledge is driven by our customers’ needs,” said Krauss. ”We have proactive staff with broad skillsets, who understand how the whole development cycle works. They all know each other and have insights into each other’s projects.”
FGK’s services cross the entire product clinical development cycle, and include consulting, regulatory affairs, project and data management, biostatistics, clinical monitoring, medical safety, quality assurance, and medical writing.
”We also provide some more specialised services. We are experts in pharmacovigilance, collecting the data, analysing it, reporting events to authorities and committees for approved drugs, and communicating with drug safety monitoring committees and investigators. We can also act as legal representative for sponsor companies with no subsidiary in Europe,” said Krauss.

Flexibility and agility
Small and medium biotech and medtech companies need a proactive partner that thinks like a developer. They also need fast responses when things change.
”Our flat hierarchies and the fact that the vast majority of our staff have academic qualifications in science and understand innovation means that we can make decisions quickly,” said Krauss. ”We are small, smart and flexible, and no individual client contributes more than 15% of our revenues. This means that our time and priorities are not dominated by any individual account. The smallest client is just as important as the largest.”
Both local and global knowledge is important, and while FGK’s headquarters are based in Germany, its staff members know the field of clinical trials in the Nordic region well. Within FGK’s reach, especially in Eastern Europe, there are many trial sites specialized in certain – often rare – indications, which can be beneficial also for sponsor companies that are not located in these countries.

What’s next for FGK
FGK has grown steadily over the past 16 years, and the plan is to continue to grow slowly and organically, whilst remaining independent as an owner-driven company.
”We are constantly on the look out to see how we can support our clients better, for example we see a great potential in our pharmacovigilance services, which we offer via our subsidiary FGK Pharmacovigilance GmbH,” said Krauss.
In 2018, FGK set up FGK Representative Service B.V in Amsterdam, the Netherlands, replacing the UK site in order to continue offering services of legal representation within the EU after Brexit.