In recent months, regulators have placed an even stronger emphasis on data quality in clinical trials. In November 2025, the FDA published a final guidance from the Patient-Focused Drug Development (PFDD) series addressing the selection, development, and modification of fit-for-purpose Clinical Outcome Assessments. The document reinforces expectations for sponsors and clinical sites regarding the planning, documentation, and justification of data used to assess the safety and efficacy of therapies.

The new FDA guidance clearly states that clinical data — including patient-reported data — must not only be complete, but also clinically meaningful, appropriately planned, and fully traceable throughout every stage of a clinical trial. This approach directly increases the importance of data integrity, high-quality source documentation, and continuous audit and inspection readiness.

In practice, audit readiness is no longer an ad hoc activity prepared only in anticipation of an inspection. Instead, it has become an integral and ongoing element of clinical trial conduct. It encompasses the organization of the study team’s work, documentation practices, continuous data oversight, and strict compliance with the protocol and applicable guidelines.

At BRG, data quality has been one of the core pillars of our operations for many years. Clinical trials are conducted based on:

• clearly defined and consistent operational processes,

• reliable and complete source documentation,

• an experienced and stable research team,

• a strong quality culture embedded in daily practice.

This approach is confirmed in practice — BRG has successfully passed an FDA inspection, demonstrating compliance with international standards as well as a high level of organizational and operational preparedness.In the face of increasing regulatory pressure and ever more detailed data quality requirements, BRG consistently delivers on these expectations, remaining a trusted partner in both national and international clinical research projects.