2026 - Centralize to Modernize: A Stepwise Path to Agile Clinical Operations

Pharma organizations are under sustained pressure to deliver more with less. Budgets are tightening even as trial complexity grows, inspection expectations intensify and regional ways of working create fragmented processes and variable quality. Backlogs, inconsistent review practices and overextended in-country teams make inspection readiness a perennial risk. Meanwhile, leaders need a clear line of sight to key performance indicators (KPIs), costs and cycle times without sacrificing control of their data or the “in-country” touch their stakeholders value.
A centralized functional service provider (FSP) model provides a pragmatic answer. By right-shoring work, from onshore to coordinated near/offshore hubs, sponsors can standardize processes across regions, stabilize quality and unlock predictable cost profiles. Central hubs absorb non-strategic, high-volume tasks (e.g., electronic trial master file intake/QC, CTA support, EU CTR submissions and site visit report review), enabling local teams to focus on higher-value oversight and site relationships. The model follows a proven path: centralize → standardize → automate, with measurable wins such as faster intake cycles, sustained backlog prevention and inspection-ready documentation, all delivered within the sponsor’s own systems to preserve ownership and visibility.
Equally important, the approach is stepwise and customizable. Sponsors can start small/ slowly via focused pilots, then scale at their own pace, from simple task consolidation to medium complexity sub-processes and, ultimately, technology-enabled operations. Governance, transparent KPIs and role-based dashboards build trust and momentum; targeted automation (from simple bots to advanced AI-assisted workflows) compounds gains over time. The result is a delivery model that lowers cost, accelerates timelines and future-proofs clinical operations, without asking organizations to relinquish control.
Whether an organization is exploring centralization for the first time or ready to scale, this session distills years of FSP experience into a practical, stepwise playbook that can be applied immediately.
Attendees will learn how to right-shore (what stays onshore vs. what moves near/offshore), how to govern (roles, SLAs, KPIs and dashboards) and how to de-risk change (pilot design, stakeholder buy in and inspection readiness by design). The featured speakers will translate lessons learned into clear decision criteria, sample metrics and sequencing guidance, from eTMF/CTA pilots to EU CTR hubs and SVR review, so attendees can reduce cost and variability without losing control. Come for the strategy; leave with the templates, talking points and measures of success to build a credible, board-ready business case.
Register for this webinar to learn how clinical operations teams can centralize and modernize workflows to improve quality, efficiency and oversight.
Keywords: Clinical Development, Clinical Operations, Clinical Research, Clinical Trial Design, Clinical Trial Management, Clinical Trials, CRO, Drug Development, Functional Service Provider, Project Management