Since its foundation in 2002, the Clinical Trial Center Maastricht (CTCM) supports researchers in clinical trials, especially in the phase where clinical trials need to be approved, performed and monitored. For this purpose, a variety of supporting services have been developed.
‘The CTCM is often involved as early as the approval phase of scientific research on human health, such as overseeing medical and ethical trials. We also set up and manage the budgets and do contract negotiations with clinical research organisations. We set up data-management activities so that the outcome of the trials can be analysed and interpreted correctly. Alongside operational planning, we design forms to collect participants’ trial data and produce workflow diagrams for logistics. We make sure that the wellbeing of the participants in the trial is safeguarded and that the studies are performed according to the legislation. Our project managers coordinate the entirety of the research, from planning to quality assurance, and we can also hire in qualified research staff like doctors and research assistants. Since the very beginning, we have had strong links with Maastricht UMC+: we offer all of their staff, including members of Zuyderland Medisch Centrum, a dedicated helpdesk.’
‘For many reasons, University Medical Centres (UMCs) are increasingly in need of our clinical research services. The growing pressure on clinics means there is less time for scientific research; legislation is more stringent; and quality requirements are increasingly higher. Funding agencies that issue grants are also placing ever stricter requirements on scientific research, most of which is done in consortia that require a lot of alignment and interaction. Basically, UMCs want to perform basic and fundamental research, but the current trend is towards more application and product development. However, we can support UMCs in this. And if something isn't covered by our range of services, we can refer clients to the right partner in our network. Next to UMCs we have also identified new opportunities in specialized hospitals in the region and other parties, such as start-ups and medical device manufacturers with research requirements,’ says Carmen Dirksen. We offer an affordable solution to bridge the gaps, whether it is equipment or expertise and know-how.’
Carmen Dirksen says this area is full of fresh innovations. ‘The majority of clinical trials are traditionally focused on pharmaceuticals. But now we've noticed an increasing shift to medical devices. Legislation in this area is also becoming stricter. There's currently a huge innovation potential in bio-medical applications, and InSciTe and the CTCM can accelerate these exciting developments in the bio-medical world. The question we're focusing on now is how we can take the right steps in the right way to ensure we're granted access to this market.’
‘Our shared ambition with InSciTe is to make it easier for people with good ideas to make these ideas a reality. We provide clinical investigation support while InSciTe takes care of the steps before and after: firstly by confirming the validity of concepts that were develop in the lab and afterwards in translating the outcome into an economic activity such as a start-up. We now look at how our own quality assurance system lines up with the ISO guideline for clinical investigations of medical devices, so that InSciTe can fine-tune it.
In contrast to big companies, you can't expect a start-up to have the knowledge and expertise to independently market a promising concept. This means that innovations with a lot of potential often flounder in what's known as the “Valley of Death,” which is something we want to prevent. That's why we offer a combination of scientific and professional support, if possible at the earliest possible stages of research. This service is in line with our mission and is supported by KEMTA and other parties at Maastricht UMC+ where necessary.
‘The combination of activities that the CTCM and InSciTe could offer, where we support clinical investigation and InSciTe takes care of the steps before and after, is unique in the Netherlands, ’ says Carmen. InSciTe’s valorization and commercialization activities connect scientific research to the market, further boosting the appeal of our joint programme to companies both in and outside the region. A successful partnership between the CTCM and InSciTe could even improve the business climate, with a positive effect on employment, economic activity, and innovation.
The region already offers a framework for setting up a partnership, and it's our job to make that a reality over the coming years by championing our business model, promoting each other's interests, and connecting our processes. By achieving and sharing successes, especially with the Brightlands campuses, we can reach a wide audience and see the concept of our joint research, support, and valorization activities really take off.’
Carl de Bont originally studied Environmental Health Sciences and Epidemiology. After receiving his MSc from Maastricht University in 2003, Carl started working at the Clinical Trial Center Maastricht (CTCM) and at the same time followed an executive MBA at Ifmec. Since then, he has worked in a variety of positions within the company. In 2010, he became a member of the Management Team, which currently consists of himself as the Chief Commercial Officer alongside the COO and the CEO.
Prof. Carmen Dirksen studied Health Sciences (Policy and Management) at Maastricht University. Following her graduation, she started working as a researcher at Maastricht UMC+'s Department of Surgery. In 1988, she obtained her PhD in health technology assessment of laparoscopic surgery, after which she continued her work at Maastricht UMC+’s Department of Clinical Epidemiology and Medical Technology Assessment (KEMTA) – first as a senior researcher and afterwards as a senior university lecturer and acting head. In 2012, she was appointed as a professor of Health Technology Assessment of clinical interventions at Maastricht University's Care and Public Health Research Institute (CAPHRI). In 2014, she was appointed as the head of KEMTA. From June to December 2018, she was the interim CEO of the CTCM and was appointed to the position of CEO on 1 January 2019. Due to her busy schedule at the CTCM, she will step down from her position as the head of KEMTA on 1 June 2019.