Feature|Articles|October 5, 2026

Mixed Outsourcing Models Are Spreading. Is Sponsor Oversight Keeping Up?

Mixed FSP and FSO models are gaining ground as sponsors seek agility and resource flexibility, but the oversight infrastructure, audit trails, and accountability structures needed to run them well and survive regulatory inspection are consistently lagging behind the model itself.

Mixed outsourcing models have moved from exception to mainstream as sponsors look to allocate resources more deliberately, access specialized expertise, and respond to portfolio growth without building permanent internal infrastructure. The operational case is clear, but the oversight case is less settled.

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Sponsor Oversight in an Outsourced Trial: What Good Looks Like and How to Evidence It

Sponsor oversight of outsourced CRO work is often robust in practice but fails inspection because oversight decisions are fragmented across systems and lack an audit trail, requiring sponsors to document oversight as a connected operating system with clear decision records, escalation pathways, and issue resolution from start to finish.

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The Control Plane for Agentic Clinical Operations: Governing Autonomous Digital Actors in Regulated Trials

AI agents in clinical operations acquire broader autonomous capability through expanded permissions, tools, memory, and delegated authority, requiring governance focused on whether effective capability has shifted outside approved boundaries rather than whether software has changed.

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Quantifying the Financial Value of RBQM: Q&A with Sylviane de Viron, CluePoints, and Abigail Dirks, Tufts CSDD

In this Q&A, Sylviane de Viron of CluePoints and Abigail Dirks, MS, of Tufts CSDD discuss the findings of a collaborative study quantifying the financial value of RBQM, why time savings emerged as the largest driver, and what sponsors struggling to justify adoption now have that they didn't before.

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Clinical Site Readiness for Cell and Gene Therapies: Operational and Supply Chain Challenges as they Scale and as they Expand into the Community Care Setting

Cell and gene therapy access expands into community care settings only when operational coordination, site readiness, and supply chain standardization become first-order priorities equivalent to manufacturing capacity, requiring standardized processes, digital integration, and distributed logistics networks.

September 21st, 2026

Moving Beyond Disappointing Pilots: Scaling Adoption of AI-Enablement in Drug Development

Most AI pilots in drug development fail not from poor technology but from lack of strategic prioritization, organizational readiness, integrated data infrastructure, and disciplined governance, making success dependent on business discipline rather than technical capability.

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What an AI-Informed Approach Means for How Sponsors Think About Risk

In this video interview, Claire Riches, VP of clinical solutions at Citeline, explains how AI is shifting trial risk management from reactive to proactive—enabling sponsors to pressure-test protocols and anticipate pivots before a single patient is enrolled.

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Real-World Evidence Is Moving Upstream: Is the Data Infrastructure Ready?

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When There’s No Registry: Building Rare Disease Evidence That Supports Regulatory Scrutiny

In rare disease drug development where no registry or natural history dataset exists, real-world evidence quality depends on treating evidence engineering as a design-stage decision, defining intended regulatory use and standardizing endpoints, harmonization, and data provenance upfront rather than reconciling gaps after collection.