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Dr. Elke Schlüssel
Life Sciences Research

Dr. Elke Schlüssel
Freelancer Address

Birkenleiten 10
DE-81543 München
Germany
schluessel@life-sciences-research.eu

Basic Information

Areas
Domains
Field
Services
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Website
www.life-sciences-research.eu

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Skills Subjects and Other Information

Brief
Your dedicated partner for high-quality services and documents in bio-medical research
Skills & Services
I have a humanistic background, hold a life sciences degree and certificates of the EMWA professional development program (foundation: general, foundation: subject area: drug development, advanced).
During more than 15 years in basic and in clinical research I gathered experience as research scientist, clinical research associate/monitor, leader of a regulatory services group and regulatory consultant, translator, medical writer, and quality assurance manager/auditor.
I prepare, edit and proofread all documents related to the conduct and description of clinical studies a/t applying requirements, e.g.
  • protocols, observational plans,
  • patient information leaflets, informed consent forms,
  • clinical trial applications (authorities, Ethics Committees),
  • integrated clinical study reports, reports on post-marketing surveillance studies.


I also offer
  • translations of all kinds of documents English <-> German,
  • preparation of publications, presentations,
  • readability testing of PILs,
  • critical evaluation of medical/scientific literature,
  • evaluation of QM systems and preparation of SOPs.
Subjects
I have a background of biology (Dipl.-Biol. Univ., Technical University Munich), biochemistry, environmental research, food technology (Fraunhofer Institutes), phytopathology and animal experimentation.
On the clinical side, I am especially experienced in
  • diabetes, homocysteinaemia,
  • rheumatoide arthritis, osteoarthritis,
  • atherosclerosis, coronary heart disease, venous insufficiency,
  • asthma,
  • psoriasis,
  • photoimmune therapy,
  • cataract,
  • migraine, pain management,
  • antibiotics,
  • hypersensitivity,
  • renal replacement therapy (dialysis),
  • transdermal delivery of macromolecular drugs.


New subject areas are always highly welcome.
Other
I have an excellent knowledge of the legal environment of drug development, a good understanding of the needs of small biotech start-ups as well as of large pharma companies. I also know what services are expected to be delivered by contract research organisations to their clients. I work independently on a home-office basis or as integral part of a team at my clients´ premises. I am a member of EMWA and DGPharMed (German Association for Pharmaceutical Medicine) and regularly attend courses to refresh and expand my professional skills. I am actively involved in animal protection and nature conservation projects.