New Impulses in Clinical Trials
Interview with Dr. Manfred Wargenau, owner and managing director of M.A.R.C.O. GmbH & Co. KG
Clinical trials are the key to the development of new drugs and treatment methods. They are required to scientifically prove the efficacy and safety of therapies before they can benefit patients. Careful and comprehensive planning, correct recording and secure storage of patient data, valid data analyses, and high-quality result interpretation and reporting play a crucial role. M.A.R.C.O. GmbH & Co. KG, an institute for clinical research and statistics, has specialized since 1997 in the corresponding services for pharmaceutical and medical device studies. In the interview, managing director Dr. Manfred Wargenau explains how his team supports clients in mastering the constantly growing demands in clinical research and which current developments need to be taken into account.
Wirtschaftsforum: Dr. Wargenau, you founded the M.A.R.C.O. Institute in 1997. What motivated you to take this step?
Dr. Manfred Wargenau: After my work at the University Hospital Hamburg-Eppendorf and receiving my doctorate from the University of Dortmund, I initially worked in international pharmaceutical companies and then moved to contract research. The appeal was – and still is – that through collaborating with various customers and partners, a variety of interesting projects arise that require a broad range of methodologies. The motivation for founding M.A.R.C.O. was to handle various tasks such as customer acquisition, expansion, and intensification of individual services on my own and be more flexible and customer-oriented. Thus, I was able to steadily and swiftly expand M.A.R.C.O.'s range of services with my team in relevant areas.
Wirtschaftsforum: What strengths do you see in M.A.R.C.O.?
Dr. Manfred Wargenau: Our greatest strength is certainly our project-oriented strategic focus. This is ensured by competent, experienced, and dedicated employees who bring a high degree of personal responsibility and a pronounced awareness for quality control. In addition, an effective internal project management ensures a seamless flow of information between business management and project processing. It is also worth mentioning that processes are proactively accompanied by constructive feedback, which provides crucial impulses and adds value for our customers.
Wirtschaftsforum: What does the range of services of M.A.R.C.O. encompass today?
Dr. Manfred Wargenau: Our services range from conceptual study planning and consulting to data management, statistical analysis, meta-analyses, and pharmacokinetics up to the preparation of clinically relevant documents such as study reports and clinical-statistical appraisals. A particular focus lies on statistics with a team of ten statisticians. Moreover, data management has processes to ensure data integrity and security, including the coordination and monitoring of all components in the data flow of a clinical study in terms of data verification. With regard to the digitalization of processes, our in-house modular software solutions ('eSolutions') for applications in clinical studies are noteworthy: internet-based data collection system (eCRF), safety database, study documentation system (eTMF), and a process management system that reflects all processing procedures in terms of Total Quality Management. The demand for AI-based solutions is increasing, but I still see this as a challenge. Process automation undoubtedly offers opportunities, but processes in the context of clinical research are so complex, dynamic, sensitive, and highly regulated that the human factor will always play a crucial role.
Wirtschaftsforum: How do you see the future of M.A.R.C.O.?
Dr. Manfred Wargenau: We are always striving to further develop our services. Specifically, we aim to be more involved in cross-study planning, for example in the creation of clinical development plans. The goal is also to strengthen our position in project and process management from study planning to reporting. Our philosophy remains unchanged: proactive, project-oriented work to deliver high-quality services, taking into account regulatory, scientific, and customer-specific requirements.