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.

Speakers

Suchela Srivatsa, Senior Director, Clinical Operations, IQVIA

Suchela Srivatsa leads the Centralized Clinical FSP team and is responsible for overseeing the delivery of centralized hubs across multiple clients. This includes meeting KPIs and service level agreements, ensuring quality standards, managing team performance and guiding hiring and onboarding activities. The role also involves direct customer management, designing appropriate delivery solutions and maintaining operational continuity.

With more than 26 years of experience in clinical research, the speaker has held roles ranging from CRA and Clinical Project Manager to Regional Lead and centralization specialist across a variety of niche clinical functions. The speaker has over 9 years of dedicated experience in centralizing clinical trial processes and applying lean practices.

Suchela expertise includes establishing, transitioning, implementing and governing centralized teams across multiple IQVIA regions, including India, China, Latin America, North America, Slovakia, the United Kingdom and Bulgaria. Areas of centralization experience include clinical trial lead support, project management support, eTMF, investigator payments and RSU services.

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

Claire Rielly heads the hybrid strategy for FSP and Study Management and oversees both RSU and Clinical Project Management functions.  With over 20 years of clinical experience, she has a broad range of expertise. She began her career in clinical research in 1998 as a CRA and worked as a CRA, Clinical Lead and Line Manager in both CRO and pharma settings.

Since 2016, Claire has held leadership roles (Associate Director, Director and Senior Director) across multiple FSP accounts and, in 2019, became Regional Head for EMEA, driving delivery, quality, people development, financial performance and customer delivery across all FSP accounts in the region. In January 2024, she took on her present role.

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