At the 2025 Veeva R&D and Quality Summit, Luca Manfro, R&D Digital Solutions Manager at Recordati, shared how the company reduced document lifecycle time by 25% and achieved zero inspection findings by centralizing oversight on the Veeva Clinical Platform.
With growing trial complexity, Recordati moved away from a fully outsourced model to bring CROs into its internal systems—integrating eTMF, CTMS, and oversight modules to enable real-time visibility, reduce fragmentation, and standardize trial management.
The shift focused on embedding oversight activities directly into Recordati’s GxP system, replacing external trackers and email-based monitoring with structured workflows, dashboards, and audit-ready reporting. Collaboration improved significantly, with CROs and internal teams now working within a single, unified platform.
Manfro emphasized that success hinged on phased implementation, continuous training, and strong partner alignment. The transformation not only enhances operational control, but positions Recordati to fully comply with the upcoming ICH E6(R3) GCP guidelines.
With this foundation, Recordati is redefining clinical oversight by transforming compliance into a real-time, system-driven capability that scales with its global R&D ambitions.
Sponsored by Veeva Systems
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
