eClinical

Mike Wenger, chief innovation officer at CRIO, explains how AI can responsibly support data quality and monitoring with proper oversight, and why advancing eSource and EHR systems remains critical to strengthening data integrity and remote trial operations.

Jeremy Wyatt, CEO, Ametris, discusses how operational best practices for integrating wearables into oncology trials center on minimizing patient burden through thoughtful workflow design, careful device selection, and early planning to ensure digital measures fit the realities of complex patient populations.

Mike Wenger, chief innovation officer at CRIO, discusses how different site types—from academic medical centers to independent research sites—require distinct eSource approaches, and why aligning technology with site workflows is critical to study execution.

Global clinical development has evolved into a technology-enabled, highly regulated, and geographically diversified enterprise, as sponsors adapt trial design, partnerships, and operations to meet rising demands for scale, speed, and patient-centricity.

Persistent delays and inefficiencies in COA licensing and translation stem from limited pre-license access and fragmented processes, making a strong case for providing outcome assessment measures earlier to reduce risk and accelerate trial start-up.

New research finds that while eSource adoption is advancing through EHR-to-EDC workflows, scaling its impact will depend on integrating unstructured clinical data using AI, shared standards, and collaborative validation models across sites, sponsors, and vendors.

New survey data show a strong patient preference for fully remote clinical trials, underscoring how convenience, intuitive technology, and FDA-cleared digital tools are reshaping enrollment and retention strategies as decentralized models become a lasting fixture in clinical research.

New data show that applying AI to the migration of translated COAs into eCOA platforms can meaningfully reduce errors, accelerate localization workflows, and support broader global patient participation—while still relying on human reviewers to ensure linguistic precision and clinical integrity.

Strong relational governance between technology vendors and sponsor–CRO teams is becoming a critical foundation for eCOA trial success, enabling faster study launches, clearer communication, proactive issue management, and sustained quality across entire trial portfolios.

As clinical trials become more complex and decentralized, the role of the CRA is evolving from site monitor to strategic, digitally fluent partner, requiring expertise in hybrid oversight, risk-based monitoring, and multi-system data management.

As decentralized and hybrid trial models expand, eConsent is emerging as a critical tool for improving participant understanding, reducing site burden, and strengthening data integrity through digital automation, accessibility, and regulatory compliance.

Gain perspective on how agentic AI can bridge eCOA, EDC, IRT, and CTMS platforms to reduce manual effort and improve operational efficiency.

The convergence of AI, decentralized technologies, behavioral science, and real-world evidence opens the door to a new era in which the clinical trial industry proactively addresses participation barriers, integrates social determinants of health, and reimagines patient centricity.

As clinical research becomes increasingly digital, integrating rigorous cybersecurity assessments into CRO selection and qualification is essential to safeguard sensitive data and ensure trial integrity.

New guidance and technology advances are reshaping eClinical systems, positioning them as tools to accelerate enrollment, improve data quality, and reduce site and patient burden.

How the application of artificial intelligence, broader use of real-world evidence, decentralized clinical trials, master protocols, and risk-based quality monitoring, together with strong ethical oversight and increased collaboration, are contributing to better healthcare delivery and strengthening the role of clinical research in driving global health progress.

Why future-ready pharma companies must embrace AI-driven, real-time decision-making.

AI as an accelerator for data-centric, process-centric, and human-centric clinical research.

As clinical research increasingly relies on RWD to enhance trial design and patient insights, tokenization has emerged as a critical solution for securely linking disparate datasets while protecting patient privacy.

How human-centered AI that is focused on customer, user, and employee experience can drive real transformation in clinical trials and beyond by aligning intelligent technologies with the people who use them.

As wearable ECG technology advances, cardiac safety studies in clinical trials are evolving to capture richer, continuous heart data while reducing patient burden.

In this Q&A, Megan Bailey, EVP and president of central laboratories and international, Labcorp, discusses how central labs are evolving beyond testing to become strategic partners in clinical trial success.

Overcoming hurdles with licensing complexities, post-production changes, and IRB submissions can help in reducing timelines and increasing collaboration.