Your experts in medical & scientific communication and scientific data analysis - specializing in publications and literature reviews
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Dr. Silke Rinkwitz:
I am a research-experienced, versatile medical and scientific writer with thorough knowledge of medical & scientific communication in biotech and pharma
Expertise: Medical Writing, scientific publishing, strategic publication management, and clinical trials including regulatory oversight. I develop and write medical and scientific communication with a focus on clarity and precision, lead publication projects, conduct systematic literature reviews, and create regulatory deliverables for the industry. For health insurance companies, I create evidence syntheses by analyzing and evaluating scientific publications through systematic literature searches.
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Qualification and adacemic career: Education as medical assistant, graduate degree in biology (focus on microbiology/biochemistry), PhD in cell and molecular biology. 15 years of independent research in neurogenetics, neurological disorders, obesity, RNA therapies, and genome analysis/editing with student supervision as well as teaching in scientific writing. I led research projects and biosafety laboratories in Germany and abroad.
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Industry experience: Contract Research Organization (CRO), Biotech & Pharmaceutical companies. Regulatory affairs and medical writing, systematic literature reviews to meet EU regulatory requirements, publication management in oncology and immunology for a global company. I am experienced with global medical communication agency workflows, medical and legal review processes, regulatory authority communication, and strategic publication planning and manuscript revision.​
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Dr. Ehsan Amin:
I am an experienced Clinical Data Scientist with a strong scientific background in biophysics and physics, and expertise in multidisciplinary research projects in cardiology, neurology, and oncology.
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Academic Background & Research Expertise: PhD from Heinrich Heine University Düsseldorf in Biophysics/Biochemistry, with involvement in multidisciplinary research projects in cardiology, neurology, and oncology. My scientific work encompasses mathematical modeling of biological systems, signal processing, and statistical analysis of clinical data - always with the goal of quantitatively understanding complex biological processes and translating them into clinically relevant insights.
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Industry Experience & Technical Specialization: In the pharmaceutical and medical device industry, I work at the interface of clinical data management, regulatory requirements, and statistical methodology. I have comprehensive expertise in CDISC standards (SDTM, ADaM), EDC systems, creation of Statistical Analysis Plans (SAPs), and generation of Tables, Listings and Figures (TLFs) for clinical trials. Additionally, I specialize in regulatory-compliant data anonymization, data-driven modeling, and modern data visualization. My more than 15 years of programming experience in Python, R, SQL, and MATLAB forms the foundation for developing proprietary software tools for compliance-driven data processing.
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Freelance Work & Topics: As a freelancer, I support Contract Research Organizations (CROs) and pharmaceutical companies with statistical analyses, regulatory writing, and development of innovative data solutions. I advise companies on remote data capture using wearables and accompany strategic as well as operational projects in this area. Furthermore, I teach data anonymization at universities, actively contributing to the education of the next generation of data scientists in healthcare.
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