Disclosure Management System: Build Or Buy?

As global regulations tighten and public expectations rise, clinical trial disclosure has transformed from a localized compliance task into a complex, high-stakes global responsibility. Sponsors must now decide whether to build a custom, internal disclosure system or adopt a vendor-managed platform. Leveraging insights from Citeline’s Maturity Model for Clinical Trial Disclosure, we can compare both strategies through the lens of cost, risk, and operational efficiency.

Building in-house offers control but comes with steep hidden costs: long development timelines, high validation and maintenance demands, staffing challenges, and the risk of falling behind on rapidly evolving requirements. With over 130 regulatory updates issued in 2024 alone, maintaining global compliance internally is increasingly unsustainable. By contrast, vendor solutions like TrialScope Disclose offer pre-validated, automated platforms with integrated regulatory intelligence, AI-enhanced data ingestion, and real-time dashboards.

Ultimately, vendor platforms provide a future-proof solution, enabling sponsors to transition from reactive compliance to proactive transparency. For organizations seeking cost-effective scalability and audit-ready precision, buying a purpose-built disclosure platform is often the strategic path forward.