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Susanne Herzig

Leader background:
is a physician who worked in hospitals in internal medicine and surgery before joining pharmaceutical research. For over 20 years, she has worked for contract research organisations in project management, safety and medical writing. She is currently a Senior Medical Writer at ICON Clinical Research in Germany. In her current position, Susanne has been involved with developing adaptive study designs for various indications, including writing of the study protocols and Informed Consent Forms (ICFs), designing the case report forms, advising the study teams during the clinical phase of the study on medical and statistical aspects, compiling updated ICFs and protocol amendments, where necessary, based on the interim results up to writing final reports that take into account the results of interim analyses and the decisions of sponsors that were based on these results and the recommendations of Expert/Independent Advisory Committees. Moreover, Susanne has prepared and moderated meetings with regulatory authorities during which sponsors suggested adaptive designs. Based on comments from authorities, she has been involved in re-designing adaptive protocols and in meetings to explain and defend the rationale and benefit for using adaptive designs.
Medical Writing for Studies with Adaptive Design
    Level: Expert Seminar Series Area: Seminar
    Code: ESS15 Duration: 01:30:00