DSG was approached by a pharmaceutical sponsor during the beginning of the pandemic with the request to provide a decentralized platform including eSource/ePRO for direct-data-entry, Randomization, eConsent, Telehealth, Remote Monitoring and Data Management for a multi-site Phase 2 study for patients with SARS-CoV-2 in the hospital.
DSG - Case Studies
DSG was approached by a pharmaceutical sponsor with the request to provide EDC, IRT, Data Management and Biostatistics for a 2-part, multi-site Phase 1 study in adults with relapsed/refractory multiple myeloma. The sponsor specifically was looking for a team with CAR T experience, and a system that could handle their unique database build with a team that could provide in-house data management and a biostatistical team.
DSG was approached by a sponsor with the request to provide EDC, IRT, Data Management and Biostatistics for two global phase 3 projects. The sponsor also requested DSG to rescue the first of the two phase 3 studies. The sponsor needed a system that could handle multiple products such as EDC and IRT for two large multinational studies collecting tens of millions of data points seamlessly. In addition, they also needed a project team including data management and biostatistical experts that had experience managing similar studies, and the migration of millions of data points with precision.