Bioforum - The Data Masters, is an international data focused CRO, with a track record in Data Management, Biostatistics, Statistical Programming, and Medical Writing (Biometrics). We offer Sponsors online, real-time project status access and clinical data insights, that translate to business benefits for sponsors in terms of study supervision, speed, costs, and quality of work. Our Biometrics services support (1) Clinical Studies and (2) Regulatory Submissions to the FDA and other regulators (e.g., NDA, BLA). (1) At Clinical Study level we assist in creating IBs, Protocols, EDC DBs, TFLs, Statistical Analyses, CSR, etc. We are often involved in rescuing studies. Our tool BioGRID provides dashboards and data visualization to support ongoing data and safety review by study stakeholders, DMSC, etc. (2) At NDA/BLA level, we have extensive experience in creating the Integrated Summaries of Safety and Efficacy (ISS/ISE), plus the corresponding data submission packages to the FDA. See our website for case studies and webinars on accelerating FDA submissions. We have the very unique technical capability to offer all study stakeholders access to and review of their live clinical study data in submission-ready SDTM format which can be refreshed on a daily or weekly basis. As a result of our deep expertise and experiences, our unique automation tools, and Project Managers trained in Biometrics, we work very efficiently and deliver superior quality of work. Please contact otto.damsma@bioforumgroup.com who will be at the conference (booth #21).