CRO/Sponsor

As clinical development grows increasingly complex and talent markets remain constrained, sponsors must evolve beyond binary outsourcing decisions to embrace a configurable functional service provider continuum that enhances operational optionality without requiring wholesale restructuring.

Eligibility criteria alone rarely predict enrollment, which depends more on trust, hope, and fear, requiring relationship-based community engagement paired with behavioral readiness assessments rather than transactional outreach.

AI-enabled systems medicine could influence which populations are selected for trials, how biomarkers are validated, how products are positioned, how evidence is generated after launch, and how value is demonstrated to payers.

In this Q&A, Liz Beatty, co-founder and chief strategy officer at Inato, discusses how real-time patient data is reducing non-enrolling sites, why sponsor-specific technology remains the biggest barrier to adoption, and what a shift toward cross-asset site partnerships could mean for enrollment efficiency.

Protocol assumptions about patients, visit schedules, timelines, and vendors are rarely tested against operational reality until startup, but early engagement of experienced execution strategists can identify and mitigate feasibility gaps before commitments harden into expensive course corrections.

The FDA's launch of real-time clinical trial proof-of-concept studies signals a fundamental shift in regulatory oversight, one that most sponsors are not yet equipped to meet and that demands urgent investment in unified data infrastructure, quality-by-design practices, and protocol digitization.

In this Q&A, Raj Indupuri, CEO and co-founder of eClinical Solutions, discusses what the FDA's push toward continuous data review actually demands of sponsors operationally, why fragmented systems are the core obstacle, and how AI and real-world evidence fit into a more data-driven regulatory environment.

Discover how Quest Diagnostics puts its vast database of lab results to work and leverages patient and physician credibility to efficiently and effectively connect the best-fit patients to the clinical trials that will benefit from their participation.

Discover how Quest Diagnostics’ comprehensive lab data can elevate your clinical trials. Our latest white paper, "6 Ways Lab Data Can Improve Clinical Trials," explores the power of real-world data at every stage of the trial process.

Traditional CRO contracting models create misalignment between effort, progress, and financial outcomes, driving revenue recognition risk and margin volatility, but shared performance contracts linking costs to deliverables can improve transparency and accountability.

A CFO’s perspective on capital allocation, balancing risk and opportunity, and structuring successful China-based clinical programs.

In this video interview from the 2026 DIA Global Annual Meeting, Kevin Bugin, head of global regulatory policy and intelligence at Amgen and executive sponsor of TransCelerate's Embedded Pragmatic Trials initiative, reframes the FDA's continuous review expectations around real-time evidence generation and explains why quality by design—not data cleanup—is what regulators are now demanding.

In this video interview, Raj Indupuri, CEO and co-founder of eClinical Solutions, describes how giving sponsors the ability to inject their own SOPs, protocols, and governance frameworks into AI systems is the key to building the trust needed for real-world adoption.

In this video interview, Raj Indupuri, CEO and co-founder of eClinical Solutions, explains why the FDA's push toward continuous data review exposes the fragmentation at the heart of current clinical trial infrastructure and what unified data pipelines need to look like to make it possible.

From rising costs and regulatory uncertainty to persistent vaccine hesitancy, sponsors face mounting pressure to standardize operations, build community trust, and develop the behavioral capabilities needed to run vaccine trials effectively in a rapidly shifting environment.

From planning one Phase III trial at a time to digital standardization on repeat.

In this video interview, Liz Beatty, co-founder and chief strategy officer at Inato, makes the case for moving beyond trial-by-trial planning toward cross-asset site partnerships—and explains why sites are three times more likely to share patient data when sponsors make that shift.

Patient Engagement Strategies in Anti-Obesity Medication Clinical Trials: Addressing Drop Out Rate and Improving Retention

In this video interview, Liz Beatty, co-founder and chief strategy officer at Inato, explains why asking sites to use different technology for every sponsor remains a major barrier to AI adoption and what a site-first approach to technology development looks like in practice.

Real-world evidence is shifting from a post-market footnote to a concurrent validation layer running alongside trial data, requiring organizations to build unified data environments that integrate EHRs, claims, and patient-reported outcomes on an ongoing basis rather than retrospectively.

In this Q&A, Del Smith, PhD, CEO and co-founder of Acclinate, discusses how structural and relational barriers continue to limit participation from underrepresented communities in clinical trials—and what it takes to build the kind of trust that translates into lasting research impact.

Despite political headwinds, life sciences leaders are holding their ground on DEI, but translating organizational commitment into representative enrollment requires structural changes to protocol design, site selection, and community engagement that most of the industry has yet to fully make.

The CNPV program has compressed drug review timelines to as little as one to two months for qualifying sponsors, but succeeding under that pressure requires a fundamental rethink of how development teams plan, communicate, and execute.