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Über 25 Jahre Schreiberfahrung - breites Indikationsspektrum

In den vielen Jahren meiner Berufstätigkeit habe ich Schreiberfahrungen aus einem großen therapeutischen Bereich und anderen Themengebieten der Life-Sciences sammeln können. 

Im Bereich Wissenschaftskommunikation habe ich vorwiegend Originalia und Übersichtsarbeiten (Reviews) für internationale, peer-reviewed Journale geschrieben, aber auch Kongressbeiträge (Abstracts, Poster), Kongressberichte, Advisory Board Berichte, Study-Summaries und Newsletter.

Im Bereich Medical Writing habe ich Dokumente aus allen Phasen der klinischen Entwicklung (I-IV) geschrieben, vor allem Studienabschlussberichte (Clinical Study Reports, CSRs) und klinische Studienprotokolle (Clinical Study Protocols, CSPs), aber auch periodische Sicherheitsberichte (Development Safety Update Reports, DSURs) für Drug Safety. Ein weiterer Schwerpunkt liegt auf Studien der Phase III/IV, nicht-interventionellen und epidemiologischen Studien.

Wissenschaftskommunikation

Die nachfolgenden Beiträge entstanden im Rahmen meiner Tätigkeit als Medical Writerin.

Sie umfassen eine Auswahl von Publikationen, Kongressbeiträgen, Broschüren, Fachbüchern und Advisory Board Meeting Berichten, bei denen ich mitgearbeitet habe – sortiert nach Indikation in alphabetischer Reihenfolge. 

Die Nennung erfolgt mit Einverständnis der Auftraggeber oder in anonymisierter Form. Vertrauliche Inhalte sind entsprechend diskret dargestellt. Weitere Arbeitsbeispiele sende ich auf Anfrage gern zu.

  • Review zum Thema: Plazenta-Wachstumsfaktor (PlGF) und retinale Gefäßerkrankungen – experimentelle und klinische Datenlage.

  • Wolf A, Kampik A. Efficacy of treatment with ranibizumab in patients with wet age-related macular degeneration in routine clinical care: data from the COMPASS health servicesresearch. Graefes Arch Clin Exp Ophthalmol. 2014; 252(4): 647–655. doi: 10.1007/s00417-013-2562-6 (Originalia). https://pubmed.ncbi.nlm.nih.gov/24424409/

  • Marc Schargus, Daniel Pauleikhoff, Gisela Häusser-Fruh, Mathias Maier. German Health Services Research Study: Estimated Prevalence and Incidence of Pathologic Myopia and Lack of Classification of different Stages of Pathologic Myopia. ARVO Annual Meeting; Seattle, USA, 5-9 May 2013 (Kongressbeitrag).

  • Marc Schargus, Daniel Pauleikhoff, Gisela Haeusser-Fruh, Mathias Maier. Choroidale Neovaskularisation (CNV) bei pathologischer Myopie (PM): epidemiologische Daten aus einer Versorgungsforschungsstudie bei Ophthalmologen in Deutschland [Choroidal Neovascularisation in Pathological Myopia: Epidemiological Data from a Health Services Research Study Conducted in Germany]. Klin Monatsbl Augenheilkd 2013; 230(7): 707-714. DOI: 10.1055/s-0032-1328254 (Originalia).

  • Marc Schargus, Daniel Pauleikhoff, Gisela Häusser-Fruh, Mathias Maier. Lücken in der Versorgung der Pathologischen Myopie in Deutschland – Ergebnisse aus einer bundesweiten Versorgungsforschungsstudie und Gesprächen mit Fachärzten. DOG-Kongress; Berlin, 19.-22.9. 2013 (Kongressbeitrag).

  • Marc Schargus, Daniel Pauleikhoff, Mathias Maier. Choroidal Neovascularization in Pathologic Myopia: Data from a Health Services Research Study conducted in Germany. ESASO 12th International AMD and Retina Congress; Prague, Czech Republic, 2-3 November 2012 (Kongressbeitrag).

  • Studiendesign für Brolucizumab bei Patienten mit retinalem Venenverschluss (RVO), 2017, Frankfurt a.M. (Advisory Board Meeting Report).

  • Chorioidale Neovaskularisation (CNV) bei pathologischer Myopie (PM). 2012, Nürnberg (Advisory Board Meeting Report).

  • Magnolo N. Fortschritte in der Behandlung von Prurigo nodularis und Atopischer Dermatitis: Biologika im Fokus. Print Newsletter. Dezember 2024. Thieme-Verlag
  • Ständer S. Pruritus bei Prurigo nodularis und Atopischer Dermatitis. Print Newsletter. August 2024. Thieme Verlag
  • Augustin M. Pathophysiologie PN / AD und Rolle von Interleukin-31. Print Newsletter. 2024 Thieme Verlag

  • Ständer S. Interleutkin-31: Studiendaten zu Nemolizumab bei Prurigo nodularis. Print Newsletter. 2023 Thieme Verlag

  • Eschweiler, B. Neuer S1P-Rezeptor-Modulator bei Colitis ulcerosa und isolierter Proktitis. Z Gastroenterol 2024;62:879

  • Malfertheiner P, Selgrad M, Labenz J. Thieme Praxis Report: Poliprotect für das Management von epigastrischem Schmerz und Sodbrennen. Ein nachhaltiges Nutzen-Risiko-Verhältnis für Patienten und Umwelt. September 2024;1-12. Thieme Verlag

  • Labenz J. Gastroösophagealer Reflux: Zeitenwende in der Speiseröhre. Welche Änderungen birngt die neue GERD-Leitlinie 2023? Thieme-Refresher (CME-Beitrag). November 2023;1-12 November 2023

  • Müller-Lissner S, Pehl C. Laxanziengebrauch und Zufriedenheit chronisch obstipierter Frauen – eine Umfrage bei Patientinnen und Gastroenterologen in Deutschland. Z Gastroenterol 2012; 50: 573–577. DOI: 10.1055/s-0031-1299133 (Originalia)
    https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0031-1299133

  • Chronic constipation in patients receiving palliative care: current treatment options and challenges. Elsner, F, Pastrana T. Onkologie 2011;34-52 (Poster und Artikel)

  • Gillessen A. Schnelle Symptombefreiung und gute Verträglichkeit bei Patienten mit Refluxkrankheit. MMW – Fortschritte der Medizin Nr. 1/2010 (152):21-29 (Review)

  • Mönnikes H, Pfaffenberger B, Gatz G, Hein J, Bardhan KD. Novel measurement of rapid treatment success with ReQuest: First and sustained symptom relief as outcome parameters in patients with endoscopy-negative GERD receiving 20 mg pantoprazole or 20 mg esomeprazole. Digestion 2005;71:152-158. doi: 10.1159/000101084. (Originalia).
    https://pubmed.ncbi.nlm.nih.gov/17489034/

  • Scholten T, Dekkers CP, Schütze K, Körner T, Bohuschke M, Gatz G. On-demand therapy with pantoprazole 20 mg as effective long-term management of reflux disease in patients with mild GERD: the ORION trial. Digestion 2005;72(2-3):76-85. doi: 10.1159/000087661. (Originalia).
    https://pubmed.ncbi.nlm.nih.gov/16113546/

  • Kaspari S, Kupcinskas L, Heinze H, Berghöfer P. Pantoprazole 20 mg on demand is effective in the long-term management of patients with mild gastro-oesophageal reflux disease. Eur J Gastroenterol Hepatol 2005;17(9):935-41. doi: 10.1097/00042737-200509000-00009. (Originalia).
    https://pubmed.ncbi.nlm.nih.gov/16093871/

  • Stanghellini V, Armstrong D, Mönnikes H, Bardhan KD. Systematic review: do we need a new gastro-oesophageal reflux disease questionnaire? Aliment Pharmacol Ther 2004;19:463-79. doi: 10.1046/j.1365-2036.2004.01861.x. (Review).
    https://pubmed.ncbi.nlm.nih.gov/14987316/

  • Bardhan KD, Stanghellini V, Armstrong D, Berghöfer P, Gatz G, Mönnikes H. Evaluation of GERD symptoms during therapy. Part I. Development of the new GERD questionnaire ReQuest. Digestion 2004;69(4):229-237. doi: 10.1159/000079707 (Originalia).
    https://pubmed.ncbi.nlm.nih.gov/15256829/

  • Mönnikes H, Bardhan KD, Stanghellini V, Berghöfer P, Bethke TD, Armstrong D. Evaluation of GERD symptoms during therapy. Part II. Psychometric evaluation and validation of the new questionnaire ReQuest in erosive GERD. Digestion 2004;69(4):238-244. doi: 10.1159/000079708 (Originalia)
    https://pubmed.ncbi.nlm.nih.gov/15256830/

  • Ulmer HJ, Beckerling A, Gatz G. Recent use of proton pump inhibitor-based triple therapies for the eradication of H. pylori: a broad data review. Helicobacter 2003;8(2):95-104. doi: 10.1046/j.1523-5378.2003.00129.x (Review).
    https://pubmed.ncbi.nlm.nih.gov/12662376/

  • Simon B, Müller P, Pascu O, Gatz G, Sander P, Huber R, Mascher H. Intra-oesophageal pH profiles and pharmacokinetics of pantoprazole and esomeprazole: a crossover study in patients with gastro-oesophageal reflux disease. Eur J Gastroenterol Hepatol 2003;15:791-799. doi: 10.1097/01.meg.0000059157.46867.42 (Originalia).
    https://pubmed.ncbi.nlm.nih.gov/12811310/

  • Körner T, Schütze K, van Leendert RJM, Fumagalli I, Costa Neves B, Bohuschke M, Gatz G. Comparable efficacy of pantoprazole and omeprazole in patients with moderate to severe reflux esophagitis. Results of a multinational study. Digestion 2003;67(1):6-13. doi: 10.1159/000070201 (Originalia).
    https://pubmed.ncbi.nlm.nih.gov/12743434/

  • Malfertheiner P, Kirchner T, Kist M, Leodolter A, Peitz U, Strobel S, Bohuschke M, Gatz G & the Byk Advanced Gastric Ulcer Study (BAGUS) Group. Helicobacter pylori eradication and gastric ulcer healing – comparison of three pantoprazole-based triple therapies. Aliment Pharmacol Ther 2003;17:1125-1135. doi: 10.1046/j.1365-2036.2003.01560.x (Originalia).
    https://pubmed.ncbi.nlm.nih.gov/12752349/

  • Schaltenbrand R, Huber R, Cotoraci CA, Mascher H, Potthast H, Hole U. Bioequivalence between omeprazole MUPS 20 mg as tablet and omeprazole MUPS 20 mg as tablet encapsulated in a hard gelatine capsule. Int J Clin Pharmacol Ther 2001;39:453-459 (Originalia).
    https://pubmed.ncbi.nlm.nih.gov/11680670/

  • van Rensburg CJ, Bardhan KD. No clinical benefit of adding cisapride to pantoprazole for treatment of gastro-oesophageal reflux disease. Eur J Gastroenterol Hepatol 2001;13:909-914. doi: 10.1097/00042737-200108000-00006. (Originalia).
    https://pubmed.ncbi.nlm.nih.gov/11507354/

  • Frevel M, Daake H, Janisch HD, Kellner HU, Krezdorn HG, Tanneberger D, Wack R. Eradication of the Helicobacter pylori with pantoprazole and two antibiotics: a comparison of two short-term regimens. Aliment Pharmacol Ther 2000;14:1151-1157. doi: 10.1046/j.1365-2036.2000.00827.x (Originalia)
    https://pubmed.ncbi.nlm.nih.gov/10971231/

  • Eschweiler B. Unklare Osteoporose und Frakturen: Wann an systemische Mastozytose denken? Osteologie 2025;34:238

  • Dr. Andrea Wagner und Prof. Dr. Felix Schlachetzki. Antikoagulation nach Hirnblutungen – fortführen oder absetzen? Der Allgemeinarzt 2016;2:51-54 (Mini-Review).
    https://www.rosenfluh.ch/media/arsmedici/2016/20/Antikoagulation-nach-Hirnblutung.pdf

  • Produktmonographie: Wirkstoff im Profil – Fragmin (Dalteparin).

  • Studien-Summaries zum Thema: Videoangiographie bei Durchblutungsstörungen

  • Julia Weinmann-Menke. Lupusnephritis. 1. Auflage 2021, 2. überarbeitete und erweiterte Auflage 2024. Ligatur Verlag (Fachbuch)
    ISBN: 978-3-940407-73-3

  • Immunsuppression mit Eeverolimus nach Transplantation – Nierenfunktion erhalten und abstoßung vermeiden. Dialyse aktuell 2013;17(05):276-278. DOI: 10.1055/s-0033-1348120 (Kurzartikel, Forum der Indsutrie).
    https://www.thieme-connect.de/products/ejournals/abstract/10.1055/s-0033-1348120

  • Eschweiler, B. Typ-2-Diabetes: Frühe Kombination schützt Herz und Niere. Pressebericht. Nephrologie aktuell (Thieme) 2025;8:422

  • Julia Weinmann-Menke. Lupusnephritis. 1. Auflage 2021, 2. überarbeitete und erweiterte Auflage 2024. Ligatur Verlag (Fachbuch)
    ISBN: 978-3-940407-73-3

  • Eschweiler, B. Friedreich-Ataxie: Mit Omavexolon erstmals Aussicht auf wirksame medikamentöse Therapie. Forum der Industrie. Nervenheilkunde 2024;43:391.

  • Übersichtsarbeiten zum Thema: Neues zur symptomatischen MS‑Therapie: Teil 1 – Einleitung und methodisches Vorgehen, Ataxie und Tremor und Teil 2 – Gangstörung und Spastik. 

  • Übersichtarbeit zum Thema: Bedeutung und Behandlung der Spastik bei Multipler Sklerose Ergebnisse der MOVE-1-Studie.

  • Nolte T. Fentanylpflaster in der Behandlung starker chronischer Schmerzen. MMW – Fortschritte der Medizin Nr. II/2009 (151):104-110 (Review).

  • Stintzing S. et al. Thieme Case Report. Encorafenib plus Cetuximab beim fortgeschrittenen kolorektalen Karzinom. Februar 2025: 1-16 [Link]

  • Eschweiler B. Metastasiertes Kolonkarzinom mit BRAF-Mutation – BERING-CRC: Real-World-Daten bestätigen hohen Wert der zielgerichteten dualen Therapie mit Encorafenib plus Cetuximab. Onkologische Welt 2024;15:503-505 [PDF zum Download]

  • Eschweiler B. Capivasertub plus Fulvestrant – Neue Zweitlinientherapie für ER-positiven/HER2-negativen Brustkrebs mit PIK3CA/AKT1/PTEN-Alterationen verlängert progressionsfreies Überleben. Onkologische Welt 2024;15_446-451 [PDF zum Download]

  • von Amsberg G. Metastasiertes hormonsensitives Prostatakarzinom (mHSPC). Aktuelle Therapielandschaft mit Fokus auf die Dreifachkombination aus neuartiger Hormontherapie und Chemohormontherapie.

    Thieme-Refresher (CME-Beitrag). April 2024;1-16

  • 17 Study-Summaries: Resection of glia blastoma.

  • > 100 Study-Summaries, diverse in Deutsch und Englisch zur Behandlung der Rhizarthrose, Osteoarthritis, Epicondylitis, Frakturen mittels Orthesen und Verbänden (BSN Medical), 2015.

  • Eschweiler, B. Ergebnisse einer multizentrischen, prospektiven Post-Market Anwendungsbeobachtung einer neuartigen Orthese zur Behandlung der Rhizarthrose. 2015 (Produktinformation).

  • Eschweiler, B. Klinische Erfahrungen mit Delta-Dry Softliner. 2017 (Produktinformation).

  • Eschweiler, B. Stabilisierung und Funktionalität von vier Orthesen zur Behandlung der Daumensattelgelenkarthrose. OUP 2016;5(9) (Mini-Review).
    https://www.online-oup.de/media/article/2016/09/1ACA2E4F-0B5E-4BD5-93B6-09E907F368D7/1ACA2E4F0B5E4BD593B609E907F368D7_sopub_bns_1_original.pdf

  • Für Ärzte, Hebammen und Gesundheitsexperten mit Schwerpunkt Phlebologie. Kompressionsstrümpfe in der Schwangerschaft. Aktuelle wissenschaftliche Daten (medi GmbH), 2012 (Studienbroschüre).

  • Trainings Manual für Außendienstmitarbeiter für Lilly (Evista® bei Osteoporose). 2002.

  • Mögliche Mechanismen der spontanen Rückbildung bei Bandscheibenvorfällen und die Rolle der interventionellen Schmerztherapie (Systematische Literaturrecherche).
  • Eschweiler B. Unklare Osteoporose und Frakturen: Wann an systemische Mastozytose denken? Osteologie 2025;34:238

  • Burghuber OC, Köberl G, Lenk-Feik S, Schantl M, Sander P, Hammer A. Effectiveness and safety of ciclesonide in the treatment of patients with persistent allergic or non-allergic asthma in medical practice (Data from a non-interventional study conducted in Austria). Wien Klin Wochenschr 2014;126(17-18):537-548 . doi: 10.1007/s00508-014-0576-7 (Originalia).
    https://pubmed.ncbi.nlm.nih.gov/25123142/

  • CME-Folder: Schweres Allergisches Asthma (SAA) im Dialog. Xolair, Novartis, 2012.

  • Beck E. Therapie von Asthma und COPD in Deutschland. Ergebnisse einer Praxisumfrage bei Pneumologen. MMW-Fortschritte der Medizin Originalien Nr. II/2012 (154. Jg.), S. 27-32 (Originalia).

  • Bethke TD, Lahu G. High absolute bioavailability of the new oral phosphodiesterase-4 inhibitor roflumilast. Int J Clin Pharmacol Ther 2011 Jan;49(1):51-7. doi: 10.5414/cpp49051 (Originalia).
    https://pubmed.ncbi.nlm.nih.gov/21176727/

  • Vogelmeier CF, Hering T, Lewin T, Sander P, Bethke TD. Efficacy and safety of ciclesonide in the treatment of 24,037 asthmatic patients in routine medical care. Respir Med. 2011;105(2):186-194. doi: 10.1016/j.rmed.2010.09.016.
    https://pubmed.ncbi.nlm.nih.gov/21067906/

  • Kraemer S, Minarzyk A, Forst T, Kopf D, Hundemer HP. Prevalence of metabolic syndrome in patients with schizophrenia, and metabolic changes after 3 months of treatment with antipsychotics–results from a German observational study. BMC Psychiatry. 2011;11:173. doi: 10.1186/1471-244X-11-173 (Originalia).
    https://pubmed.ncbi.nlm.nih.gov/22044502/

  • Schneider E, Linden M, Weigmann H, Wagner T, Quail D, Hundemer HP, Hegerl U. Early reduction in painful physical symptoms is associated with improvements in long-term depression outcomes in patients treated with duloxetine. BMC Psychiatry.  2011 Sep 20;11:150. doi: 10.1186/1471-244X-11-150 (Originalia).
    https://pubmed.ncbi.nlm.nih.gov/21933428/

  • Wehmeier PM, Schacht A, Dittmann W, Banaschewski RT. Reasons for Physicians‘ Choice of Medication in Medication-Naive Patients with ADHD: Baseline Data from the COMPLY Observational Study. Curr Drug Ther 2010(5): 139-150. 10.2174/157488510791065076 (Originalia)
    https://benthamscience.com/article/16490

  • Wehmeier PM, Dittmann RW, Schacht A, Helsberg K, Lehmkuhl G. Morning and evening behavior in children and adolescents treated with atomoxetine once daily for attention-deficit/hyperactivity disorder (ADHD): findings from two 24-week, open-label studies. Child Adolesc Psychiatry Ment Health. 2009;3(1):5. doi: 10.1186/1753-2000-3-5 (Originalia).
    https://pubmed.ncbi.nlm.nih.gov/19203355/

  • Dittmann RW, Wehmeier PM, Schacht A, Lehmann M, Lehmkuhl G. Self-esteem in adolescent patients with attention-deficit/hyperactivity disorder during open-label atomoxetine treatment: psychometric evaluation of the Rosenberg Self-Esteem Scale and clinical findings. Atten Defic Hyperact Disord. 2009 Dec;1(2):187-200. doi: 10.1007/s12402-009-0011-5 (Originalia).
    https://pubmed.ncbi.nlm.nih.gov/20234829/

  • 131. DGIM-Kongress: BioNTech Symposiumsbericht. Impfmüde? Wach bleiben bei den Themen COVID 19 und Long COVID! BioNTech

Medical Writing

Die aufgelisteten Dokumente stammen aus meiner Tätigkeit im Bereich regulatorisches Medical Writing, gelistet in alphabetischer Reihenfolge. Dies sind vor allem:

  • Clinical study reports (CSRs) and protocols (CSPs) (Phase I bis III Studien, gemäß ICH E3 und E6)
  • Non-interventional PASS / Non-PASS study reports / Phase IV
  • Clinical investigation reports (CIRs gemäß MEDDEV rev 4.)
  • Psychometric reports

  • Andere Post-market surveillance reports

Aus Gründen der Vertraulichkeit sind Produktnamen nicht genannt. Die Angaben erfolgen anonymisiert.

  • A phase I, open-label dose-escalation-study to investigate the safety of a next generation TGF-β2-selective antisense oligonucleotide, in subjects with primary open-angle glaucoma. 2018 (NIS Clinical Study Report)

  • An open-label study to assess the safety and tolerability of a subcutaneous immunotherapy product in adult patients with house-dust mite mediated allergic rhino-conjunctivitis. 2019 (Clinical Study Report)

  • A multicenter randomized double-blind placebo-controlled clinical trial for evaluation of efficacy and safety of specific immunotherapy with an allergoid preparation of house dust mite (Dermatophagoides pteronyssinus) in patients with allergic bronchial asthma and with allergic rhinitis or rhinoconjunctivitis. 2019 (Clinical Study Report)

  • A multi-centre, randomised, double blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of an immunotherapy product in the prevention of seasonal symptoms in patients with seasonal allergic rhinoconjunctivitis due to birch pollen. 2018 (Clinical Study Report)

  • A double-blind randomized parallel group study of different doses of a specific immunotherapy product compared to placebo in patients with seasonal allergic rhinoconjunctivitis exposed to grass pollen. 2018 (Clinical Study Report)

  • A multi-center, double blind, placebo-controlled study to explore the safety and efficacy of a specific immunotherapy product in patients with seasonal allergic rhinoconjunctivitis due to birch pollen. 2016 (Clinical Study Report)

  • A pre-season, single site, single-blind, parallel group, randomized study to determine the tolerability and safety of two new cumulative doses of a specific immunotherapy product compared with placebo in patients with seasonal allergic rhinoconjunctivitis due to grass pollen allergy. 2017 (Clinical Study Report)

  • A multi-centre, randomised, double blind, placebo-controlled study to determine the optimal effective and safe dose of a speicific immunotherapy product for the treatment of patients with seasonal allergic rhinoconjunctivitis due to grass pollen. 2017 (Clinical Study Report)

  • A pre-season, randomised site, single-blind, parallel-group study to determine the tolerability and safety of a new cumulative dose of a novel immunotherapy product compared with the conventional dose and placebo in patients with seasonal allergic rhinoconjunctivitis due to grass pollen allergy. 2018 (Clinical Study Report)

  • A Study of Tolerability and Safety of a New Cumulative Dose of a novel speicific immunotherapy product. 2018 (Clinical Study Report)

  • A randomized, double-blind, placebo-controlled, multicenter, 28-week treatment study with an 8 week follow-up period to investigate the impact of a subcutaneous monoclonal antibody on quality of life measures as well as the incidence and severity of angioedema in patients with chronic spontaneous urticaria having a history of angioedema despite H1-antihistamine therapy. 2015 (Clinical Study Report)

  • A multi-centre, non-interventional study of the long-term safety and efficacy of a peptide hormone in children requiring growth hormone treatment. 2021 (NIS Clinical Study Report)

  • A multicentre, noninterventional study of the long-term efficacy and safety of a peptide hormone for the treatment of adult patients with growth hormone deficiency. 2021 (NIS Clinical Study Report)

  • Analysis if psychometric and measurement properties of the UF bleeding assessment instruments – the MP SAP-c v3 and the UF-DBD (Item 1 of the UF-DSD v3) -based on two phase 3 studies. 2019 (Psychometric Report)

  • Retrospective and Prospective Observational Study to Evaluate the Care Map of Postmenopausal Women with Osteoporosis in Routine Clinical Practice of Office Based Specialists in Switzerland (CAMPOS). 2016 (Synopsis Report)

  • Non-interventional study to assess continuation rates and satisfaction in women using Qlaira® or Progestin Only Pills (CONTENT), NCT01200186. 2015 (NIS Clinical Study Report)

  • DIVA, Daily practice treatment and Influence of Visanne on the patient Assessment of quality of life parameters. NCT01595724. 2015 (NIS Clinical Study Report)

  • MiCo – Mirena® or conventional medical treatment for menorrhagia (MA0901 and MA0701). NCT01085487. 2011 und 2012 (NIS Clinical Study Reports)

  • A Non-interventional Study on Xarelto for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer (COSIMO). NCT02742623. 2020 (NIS Clinical Study Report)

  • RADOA-Registry: Reversal Agent use in patients treated with direct oral anticoagulants or vitamin K antagonists. NCT03537521. 2017 (NIS Clinical Study Report)

  • XALIA – Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE). 2016 (NIS Clinical Study Report)

  • Prospective Non-Interventional Observational Study of Use of TRIUMEQ and Corresponding Monitoring Measures in Clinical Practice in Germany (TRIUMPH). NCT02342769. 2019 (NIS Clinical Study Report)

  • A prospective, non-interventional study of the use of dolutegravir as part of combination antiretroviral therapy in routine daily practice in Germany (DOL-ART). NCT02076386. 2018 (NIS Clinical Study Report)

  • Ventavis® (Iloprost): Evaluation of inhaled iloprost effects using the Breelib™ nebulizer, on clinical outcomes and physical activity of patients with advanced pulmonary arterial hypertension (VENTASTEP). NCT03293407. 2020 (Clinical study Report)

  • Open, randomized, mono-centre, two-parallel group clinical phase I/II trial on the evaluation of tolerability and efficacy of an intravenous infusion of human bone marrow derived autologous, CD34-negative mesenchymal stem cells for the treatment of critical limb ischemia in patients with advanced peripheral arterial occlusive disease subsequent to percutaneous transluminal angioplasty. 2015 (Clinical Study Report)

  • Therapy of Essential Hypertension With Kinzal/ Kinzalplus® (KINZAL). 2012 (Clinical Study Report)

  • Ambulantes Register zur Morbidität des Vorhofflimmerns (ATRIUM). 2012 (Registerstudie, Abschlussbericht)

  • MONITOR-CKD5 – Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5 (MONITOR-CKD5). 2015 (NIS Clinical Study Report)

  • Multicenter observation on the use of biosimilar Epoetin alfa Hexal – A non-interventional trial in patients with chronic kidney disease stage 5 on change of treatment targets over time. 2015 (NIS Clinical Study Report)

  • Non-interventional study to investigate the use of MIRCERA® in large nephrology centers and to investigate possible differences in daily routine between centers with respect to anemia control. NCT01051323. 2014 (NIS Clinical Study Report)

  • MS patients treated with BETAferon®: PREDICTors of treatment adherence (BETAPREDICT). NCT02486640. 2020 (NIS Clinical Study Report)

  • PROmyBETAappGame: Ascertaining medication usage & Patient Reported Outcomes via the myBETAapp® and exploring gamification in patients with multiple sclerosis treated with Betaferon®. 2020 (NIS Clinical Study Report)

  • Study Evaluating Betaferon’s Safety and Tolerability In Pediatric Patients with Multiple Sclerosis (BETAPAEDIC). NCT00963833. 2017 (NIS Clinical Study Report)

  • Zukünftige Entwicklungen in der MS-Therapie. Erhebung zum Management von Patienten mit Multipler Sklerose (Genzyme). 2016 (Abschlussbericht)

  • Betaferon® injection management: Non-interventional study of PDA-supported effects on adherence to a long-term injection therapy (BETAPATH). 2015 (NIS Clinical Study Report)

  • A non-interventional study to investigate factors associated with adherence to Exelon® patch for the treatment of Alzheimer’s disease (STATT). CENA713DDE23. 2013 (NIS Clinical Study Report)

  • A special drug use investigation of Bayaspirin tablet in patients with acute ischemic stroke. 2013 (NIS Clinical Study Report)

  • Observation of Leuprone® HEXAL® in everyday clinical practice. Non-interventional study on the course of therapy, tolerability profile and anamnestic factors (LEAN). 2021 (NIS Clinical Study Report)

  • Comparative study of intravesical instillation of mitomycin-C, BCG-RIVM, and BCG-Tice in primary and recurrent Ta-T1 papillary carcinoma and primary carcinoma in situ of the urinary bladder. 2018 (Clinical Study Report)

  • OnkoDataMed (ODM) patient registry analysis of Bacillus Calmette-Guerin (BCG)-RIVM in high-risk non-muscle invasive bladder cancer (NMIBC) patients. 2018 (Registerstudie, Clinical Study Report)

  • Treatment efficacy and tolerability of intravesical Bacillus Calmette-Guerin (BCG)-RIVM strain: induction and maintenance protocol in high-grade and recurrent low-grade non-muscle invasive bladder cancer (NMIBC). 2018 (NIS Clinical Study Report)

  • Epoetin alfa Hexal® in oncology and haematology patients with chemotherapy induced anaemia. A noninterventional observational study (OncoBOS). 2017 (NIS Clinical Study Report)

  • Rituximab for the Treatment of Chronic Lymphocytic Leukemia, “CLL NIS” (MabThera®). 2016 (NIS Clinical Study Report)

  • SORINT – SORafenib for the treatment of patients with INTermediate stage hepatocellular carcinoma. 2016 (NIS Clinical Study Report)

  • INSIGHT – Internationale Studie mit Nexavar® zur Sicherheit und Wirkung im Rahmen der HCC Therapie (International Study With Nexavar® About Safety and Efficacy in Carcinoma Hepatocellular Therapy. 2015 (NIS Clinical Study Report)

  • A multi-centric, open-label, phase II study investigating the combination of Afinitor with paclitaxel and carboplatin in first line treatment of patients with advanced (stage IV) large cell lung cancer with neuroendocrine differentiation (LC-NEC). 2015 (Clinical Study Report)

  • Observation of Leuprone® HEXAL® in everyday clinical practice. Non-interventional study on the course of therapy, tolerability profile and anamnestic factors (LEAN and LEAN II). 2018 (NIS Clinical Study Report)

  • Ergebnisse der Post-Market Anwendungsbeobachtung Trocodur Rhizo Forte Daumenorthese. 2016 (Abschlussbericht)

  • Ergebnisse der Beobachtungsstudie: Behandlung von Patienten mit akuten, ruhigstellungspflichtigen offenen oder geschlossenen Verletzungen an Extremitäten mittels Schienenversorgung durch Delta-Express™. 2016 (Abschlussbericht)

  • Multicenter, open-label, non-interventional study to evaluate the impact on clinical effects, user-friendliness and patient’s acceptance of AirFluSal® Forspiro® in the treatment of asthma under real life conditions (ASSURE). 2017 (NIS Clinical Study Report)

  • DuoResp Spiromax® for the daily routine of asthma and COPD treatment. Non-Interventional Study to Evaluate Patient’s Satisfaction and Preference, the Usability of DuoResp SPIROMAX® and the Impact on Clinical Effects. 2017 (NIS Clinical Study Report)

  • Use of diagnostic measures in chronic obstructive pulmonary disease (COPD) in routine practice and their impact on treatment decisions. Study protocol. 2017 (Clinical Study Protocol)

  • MOVE – A randomized, double-blind, placebo-controlled, multicenter, cross-over study to assess the effects of a 3-week therapy each with QVA149 versus placebo on pulmonary function and average physical activity levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). 2015 (Clinical Study Report)

  • A randomized, multicenter, open-label, cross-over study to assess lung function and patient preference after a 4 week treatment each with QVA149 vs. tiotropium in patients with stable chronic obstructive pulmonary disease (COPD) and moderate to severe airflow limitation who are on a tiotropium therapy (FAVOR study). 2015 (Clinical Study Report)

  • Wirksamkeit und Verträglichkeit von Ligosan® Slow Release bei erwachsenen Patienten mit chronischer oder aggressiver Parodontitis unter Praxisbedingungen. 2013 (AWB Clinical Study Report)

  • Identification of risk factors for skin toxicity and evaluation of clinical management in patients with recurrent platinum-sensitive and platinum-resistant ovarian cancer treated with a medical device (Clinical Investigation Plan)

  • A prospective, single-arm, open-label multicenter clinical investigation to assess the safety and performance of a breast implant product in healthy female subjects. 2021 (Clinical Investigation Report)

  • A randomized, controlled, double-blind, two- arm clinical trial to assess safety and efficacy of transcutaneous vagus nerve stimulation in patients with drug-resistant epilepsy. 2015 (Clinical Investigation Report)

Kunden

Zu meinen Kunden zählen Arzneimittel- und Medizinprodukte-Hersteller, Auftragsforschungsinstitute (CROs), Agenturen, Verlage, akademische Einrichtungen und andere Fachpersonen.

Diese Kunden haben auf meine Expertise vertraut (in alphabetischer Reihenfolge):

  • 3K Agentur für Kommunikation
  • Bayer AG
  • Biermann-Verlag, Medizin
  • Blueprint Medicines
  • Boehringer Ingelheim Schweiz
  • BSN medical
  • Chiltern International GmbH
  • DocCheck agency AG (ehemals Antwerpes AG)
  • dtv Verlagsgesellschaft
  • Eli Lilly GmbH
  • Helbig Consulting GmbH
  • Institut Dr. Schauerte (IDS)
  • Janssen Cilag GmbH
  • Klinik für Neurologie, Universität Regensburg
  • kw Medipoint
  • Ligatur Verlag
  • medi GmbH
  • Metronomia Clinical Research GmbH
  • mgo-Fachverlage
  • Novartis
  • Novo Nordisk
  • Nycomed Deutschland GmbH
  • Nycomed Österreich
  • PharmKomm Köln
  • Praxis für interventionelle Schmerztherapie OWL, Rheda-Wiedenbrück
  • Protagen AG
  • Takeda Pharmaceutical
  • TBWA Switzerland AG
  • Trinity Biotech GmbH
  • Thieme Verlag
  • Universitätsklinikum Tübingen
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