Services
Clinical research
Medaimun's clinical service covers the entire spectrum of planning, execution, and evaluation of drug substances in all stages of clinical development. Medaimun specializes particularly in Phase II studies, also known as "Proof of Concept" studies. Our clinical service includes:
Clinical Trial Management
As a dedicated clinical trial site, we provide full-service management of clinical studies – reliable, efficient, and fully compliant. Our focus is on the operational execution of trials at the highest level of quality. This includes all relevant processes from study preparation and initiation to monitoring, documentation, and final reporting.
Our experienced team of investigators and study nurses ensures precise implementation in line with ICH-GCP and all applicable national and international regulations. Patient safety and data quality remain our highest priorities throughout the entire trial lifecycle.
With a proven infrastructure and expertise across multiple therapeutic areas, we are well positioned to handle complex study protocols and demanding recruitment goals. Streamlined processes and operational flexibility allow us to deliver on time and within budget.
For sponsors and CROs, we are a trusted partner who takes full responsibility for the operational conduct of clinical trials and contributes significantly to the success of clinical development programs.
Consulting
We provide comprehensive consulting services in all matters related to infectiology, pneumology, and allergology.By combining medical expertise with scientific and regulatory know-how, we support our partners with tailored solutions. Our mission is to reliably guide pharmaceutical companies, biotech firms, and clinical research partners through every stage of development, creating the best conditions for successful clinical trial projects.
Our consulting services include:
- Consulting across all phases of product development - from early clinical planning to market launch
- Scientific consulting - expertise on indications, therapeutic options, and patient-centered approaches
- Medical consulting - specialized expertise in indications, treatment options, and patient-centered questions
- Support with approval processes - guidance through approval processes and communication with authorities
- Preparation of expert assessments - guidance through approval processes and communication with authorities
With our consulting services, we ensure that our partners can make scientifically sound, regulatory-compliant, and practice-oriented decisions – delivered with efficiency, transparency, and focus.
Protocol Development
Prof. Zielen, our Medical Director, is a globally recognized asthma specialist. He is an active member of the EAACI Working Group on Diagnosis and Treatment of Allergic Asthma, a contributing author of the German guidelines on pediatric asthma, and highly regarded as an expert in bronchial allergen provocation (1–3).
He has developed multiple study protocols and has served as Principal Investigator (PI) or National Coordinator in numerous clinical trials.
- Effects of tregalizumab on allergen-induced airway responses and airway inflammation in asthmatic patients Phase 2 (allergic asthma in ages ranging from 18 to 65)
Sponsor: T-Balance
EudraCT Number: 2020-000585-41.
- A prospective multicenter placebo-controlled trial to study the efficacy and safety of Tiotropium in preventing severe asthma exacerbations in partial and uncontrolled preschool asthma. TIPP-Study (Asthma Alter 1-5 Jahre)
Sponsor: Goethe-University (IIT Prof. Zielen)
EudraCT Number: 2021-000190-81
- Efficacy and Safety of QGE031 (Ligelizumab) versus Placebo and Omalizumab in patients aged 18-75 years with asthma (Asthma ages 18-75 Jahre)
Sponsor T-Balance: Novartis GmbH
EudraCT Number:2020-000585-41.
A detailed analysis of the study can be found in reference 5.
References:
- Medical algorithm: Diagnosis and treatment of house dust mite-driven allergic asthma. Schulze J, Agache I, Eguiluz-Gracia I, Trischler J, Zielen S. Allergy. 2023 May;78(5):1397-1399. doi: 10.1111/all.15654.
- EAACI position paper on the clinical use of the bronchial allergen challenge: Unmet needs and research priorities. Agache I, Antolin-Amerigo D, … et al. .Zielen S, Eguiluz- Gracia I. Allergy. 2022 Jun;77(6):1667-1684. doi: 10.1111/all. 15203.
- The late asthmatic reaction is in part independent from the early asthmatic reactions. Zielen S, Alemdar O, Wimmers A, Gronau L, Duecker R, Hutter M, Trischler J, Monchy JG, Schubert R. Int J Mol Sci. 2025 Feb 27;26(5):2088. doi: 10.3390/ijms26052088.
- Dual role of microRNA-146a in experimental inflammation in human pulmonary epithelial and immune cells and expression in inflammatory lung diseases. Gronau L, Duecker RP, Jerkic SP, Eickmeier O, Trischler J, Chiocchetti AG, Blumchen K, Zielen S, Schubert R. Int J Mol Sci. 2024 Jul 13;25(14):7686. doi: 10.3390/ijms25147686.
- Ligelizumab treatment for severe asthma: learnings from the clinical development programme. Trischler J, Bottoli I, Janocha R, Heusser C, Jaumont X, Lowe P, Gautier A, Pethe A, Woessner R, Zerwes HG, Zielen S. Clin Transl Immunology. 2021 Mar 15;10(3):e1255. doi: 10.1002/cti2.1255.
Digital Patient Recruitment
For patient recruitment, we work closely with Studienproband.de , a specialized platform that was originally developed out of the Medaimun environment and now operates as an independent company. This continued close collaboration supports the structured outreach and prequalification of potentially suitable study participants.
In addition, Medaimun has its own digital infrastructure to support recruitment directly under its own name, including digital campaigns, web forms, tracking, and CRM-supported processes. Combined with established networks and patient communities, this enables an efficient and target-group-oriented approach to identifying suitable study participants.
Through the close integration of these recruitment pathways into our study processes, we are able to act as a high recruiter in suitable projects and support particularly fast and reliable patient recruitment. This is a key factor in the successful and timely conduct of clinical trials.
Schedule an appointment
Schedule your appointment with Prof. Dr. Zielen online
