KREZEL

Biologist by training, I am Consultant in Clinical Research and Development with more as 20 years of experience in clinical research in CROs, pharma and biotech. Offers consulting services to biotech and pharma in the set-up of clinical trials, building and management of clinical teams; pharmacology, pre-clinical and clinical project management, operational management, CROs supervision, quality system development and update, internal audit and investigational sites’audits, compliance support, process improvement, writing of regulatory and study related documents.(as protocol, Investigator brochure, briefing book, informed consent form) Offers training and support services to medical devices companies for new regulation implementation