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 clear line of sight to KPIs, costs, and cycle times—without sacrificing control of their data or the “in country” touch their stakeholders value.

A centralized 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., eTMF intake/QC, CTA support, EU CTR submissions, 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 you are exploring centralization for the first time or ready to scale, this session distills years of FSP experience into a practical, stepwise playbook you can apply immediately. You’ll learn how to right shore (what stays onshore vs. what moves near/offshore), how to govern (roles, SLAs, KPIs, dashboards), and how to de risk change (pilot design, stakeholder buy in, and inspection readiness by design). We’ll translate lessons learned into clear decision criteria, sample metrics, and sequencing guidance—from eTMF/CTA pilots to EU CTR hubs and SVR review—so you 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 now to learn how IQVIA delivers scalable, high-quality solutions that meet the demands of modern clinical research.

Key takeaways:

• The Right Shoring Blueprint - How to decide what stays onshore and what moves to near/offshore hubs to optimize cost, speed, and quality—while protecting country nuance and stakeholder confidence.
• Centralize → Standardize → Automate - A practical playbook for consolidating work, harmonizing SOPs/WIs, and layering in fit for purpose automation that prevents backlogs and shortens cycle times.
• Ownership Without Overhead - Ways to keep data, systems, and decision rights firmly with the sponsor—even as centralized teams execute day to day tasks for reliable, inspection ready output.
• Inspection Readiness by Design - How specialized, centralized reviewers and consistent QC raise quality bars and create a repeatable state of readiness across portfolios and regions.
• Change Management That Sticks - Proven tactics to start small, show value fast, and scale—from piloting eTMF/CTA support to expanding into CPM support, EU CTR hubs, and SVR review.

Speakers:

Suchela Srivatsa, Sr Dir, Clinical Operations, IQVIA

Claire Rielly, VP, Hybrid Strategy and Study Management Lead, IQVIA

For more information and to register, click here.