The applicant is informed of the outcome and, if Roche is interested in presenting the concept, the auditor is contacted and asked to provide more details and a final minutes on the IIS in order to be considered for full approval. Research studies (IIS) are clinical studies initiated and managed by non-pharmaceutical researchers such as individual researchers, institutions, collaborative study groups or cooperative groups. The researcher is responsible for the legal and regulatory responsibilities of the experimental sponsor for the completion and completion of the study, as defined in all applicable laws and regulations. Roche requires that the following documents be available prior to the start of assistance: All requests for assistance are reviewed to ensure that they do not exceed fair local value. Requests for assistance for expenses not related to the study are strictly prohibited. Clinical trials initiated by researchers can play a key role in answering important medical and scientific questions about Roche products and related therapeutic areas. Such clinical trials can help improve the understanding and appropriate use of Roche products, which improves patient care and presents new ideas for further disease research to improve patient treatment. Roche can support studies initiated by auditors regarding drug procurement, financing, equipment and/or information, as permitted by local laws and regulations, provided they are consistent with the strategic areas of strategic interest defined by the company. Researchers are invited to submit their approach proposal via the IIS submission portal. The presentation of this concept will be reviewed jointly by the Roche Review Committee on the basis of scientific merits and guidance to business research and development plans.
Download the IIS Query Users Guide here, which provides you with step-by-step instructions for registering and filing an IIS proposal. Each new treatment is usually tested in three phases of clinical trials before regulators deem it safe and effective.