Support with finding classification, CAPA wording, root cause analysis and closure evidence. Deviation and protocol deviation management support.

Quality control of GCP documents, plans, forms, logs and reports — protocols, ICFs, monitoring plans, TMF indexes and study reports.

Creation or refinement of GCP SOPs, templates, forms and controlled processes. Gap analysis against current QMS and regulatory guidance.

Targeted support to prepare sponsor teams and study files for regulatory inspection. MHRA, FDA, EMA and other health authority contexts.

Desktop or remote vendor audits for clinical trial suppliers — CROs, labs, IRT/IWRS vendors, central labs and other service providers.

TMF completeness, quality, timeliness, filing logic, audit trail and inspection readiness. Covers both paper and electronic TMF systems.