Policies and Procedures
Dr. Elke Schlüssel
Life Sciences Research
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Skills Subjects and Other Information
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.
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
rheumatoide arthritis, osteoarthritis,
atherosclerosis, coronary heart disease, venous insufficiency,
migraine, pain management,
renal replacement therapy (dialysis),
transdermal delivery of macromolecular drugs.
New subject areas are always highly welcome.
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.