In the last decade, scientific breakthroughs have transformed the landscape of drug development – especially in cell and gene therapies, with biomarker-driven FDA approvals increasing by 10%.
Yet despite these innovations, the cost and timeline to bring new therapies to market remain largely unchanged. Drug approvals and clinical trial registrations have grown, but development continues to take an average of 12.5 years, driving up operational burden without improving speed.
While biology and data have become more digitized, these gains haven’t translated into efficiency. Streamline Document Authoring (SDA) is EPAM’s AI-powered platform that accelerates clinical document authoring and protocol development—critical steps in the trial process. It reduces protocol amendments, improves documentation quality, and enhances data reuse. With trials averaging $40,000 per day, SDA drives significant savings.
In this executive viewpoint, Kate Dugan, Principal in Life Sciences Consulting at EPAM, and Christopher Waller, Vice President and Chief Scientist at EPAM, share a range of insights on this key topic.