How Spineart Accelerated FDA Readiness and Strengthened Clinical Operations

In the fast-paced world of clinical research, maintaining compliance while ensuring study efficacy can be challenge. For Spineart, a medical device company conducting pivotal U.S. clinical trials, managing thousands of regulatory and Trial Master File documents across teams and sites was becoming increasingly complex. Limited visibility, manual tracking, and the risk of non-compliance with FDA and 21 CFR Part 11 requirements made submission readiness difficult to sustain. 

During this session, the Spineart team will share how they restructured their regulatory documentation process to gain control, improve audit readiness, and ensure data consistency across their studies.

Together, we’ll explore the practical lessons learned, from the early challenges of managing documents across sites to the steps that led to a more efficient and compliant framework for FDA submissions readiness