SCDM eSource Implementation Consortium Playbook 1: Practical advice for vendors/CROs

Clinical research is in the midst of a digital transformation, with the emergence of eSource data promising to accelerate drug development timelines, enhance patient centricity, and unlock previously unseen insights. While much has been written on the rationale for eSource approaches, practical advice on their implementation has been less widely available. As the world's leading advocate for the discipline of clinical data management, the Society for Clinical Data Management (SCDM) is in a unique position to fill this knowledge gap. To achieve this aim, the group has produced a series of podcasts in which leading experts from across the clinical research ecosystem share their case studies and practical advice on moving eSource from theory into practice. We then distilled their learnings into four playbooks, each from the standpoint of one of the main stakeholder groups: CROs and vendors, pharma, regulators, and academia/sites. This paper focuses on the technology vendor and CRO perspective.