A top 10 pharmaceutical company had successfully launched a fixed-dose combination (FDC) therapy combining a DPP-4 inhibitor and Metformin. As part of its post-marketing commitments, the sponsor initiated a Phase 4, real-world clinical trial to assess long-term effectiveness, cardiometabolic safety, and patient adherence in diverse populations.
“Clinvigilant brought a rare mix of speed, quality, and field-level experience to our post-marketing program. Their ability to operate across geographies and integrate seamlessly into our real-world data strategy was exceptional.”
Clinvigilant successfully supported a large-scale Phase 4 trial for a diabetes FDC therapy, generating real-world, regulatory-grade evidence to strengthen the product’s long-term safety profile, support label expansion discussions, and fuel payer and physician confidence.
