Dr. Elke Schlüssel
Life Sciences Research
Skills And Services Offered:
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
- diabetes, homocysteinaemia,
- rheumatoide arthritis, osteoarthritis,
- atherosclerosis, coronary heart disease, venous insufficiency,
- photoimmune therapy,
- 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.