CRO/Sponsor

Unclear boundaries between investigator-controlled and sponsor-managed data in IRT systems are creating avoidable compliance risk, particularly around investigational product inventory and quality actions.

As highly effective anti-obesity therapies emerge and regulatory expectations evolve, sponsors are adopting innovative trial designs, addressing long-term weight maintenance, monitoring lean mass preservation, and preparing for expanded safety and demographic requirements that will define the next era of obesity R&D.

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.

Learn how sponsors and CROs are adapting to evolving ICH GCP requirements while maintaining innovation in high-touch areas, ensuring patient protection, and preserving data integrity across global clinical trials.

Investigate how sponsors are responding to rapid growth in obesity drug development, including strategies for manufacturing, supply chain optimization, dosing innovations, and combination therapies to meet market and patient needs.

In this Q&A, John Kirk, principal regulatory strategist at Veristat, explains how the FDA’s Commissioner’s National Priority Voucher (CNPV) Program is accelerating operational timelines, tightening cross-functional workflows, and redefining what sponsors and CROs must deliver to secure and execute an ultra-compressed one-to-two-month review.

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 AI adoption accelerates across clinical research, clear distinctions between AI agents, AI teammates, and integrated intelligence are essential for understanding how automation will reshape site operations, workforce roles, and end-to-end study processes.

A new global Tufts CSDD survey of 387 investigative site professionals reveals broad experience with digital and decentralized trial tools, growing site-driven technology investments, and strong support for remote data collection—while highlighting persistent burdens tied to fragmented systems, training demands, and financial strain.

Emerging applications of AI/ML, automation, and digitization are helping sponsors cut clinical trial start-up times to as little as four weeks, reduce data errors, and enhance patient engagement—demonstrating how tech-enabled processes are reshaping trial efficiency and experience across the study lifecycle.

Leveraging real-world data and AI-driven insights in clinical trial planning can reduce enrollment failures, improve retention, and prevent costly rescue studies by providing a more accurate view of patient populations and site feasibility.

Melissa Hutchens, vice president of research & benchmarking at WCG, and Jimmy Garza, senior director of clinical operations at Bayer, discuss findings from the latest WCG CenterWatch Global Site Relationship Survey, revealing a decline in overall site satisfaction. They explore key drivers behind this trend, including technology usability, communication gaps, and limited site input in protocol design, and share actionable approaches to strengthen sponsor-site partnerships and improve study execution.

As biotechs expand their outsourced clinical operations, adopting a CTMS is becoming essential to ensure CRO oversight, regulatory compliance, and real-time visibility across trials and portfolios.

Gain insight into why sponsors are taking a larger role in site selection and CRO oversight using robust data to validate feasibility before launch.

Ethical and regulatory considerations for safeguarding participants in bispecific antibody clinical trials, and best practices designed to optimize their success.

Learn how increasing system complexity and patient-facing technologies are creating new burdens for clinical trial sites—and what vendors and sponsors can do to streamline operations and improve support.

See how early patient inclusion, integrated regulatory planning, and seamless CRO partnerships can help biotechs accelerate progression from Phase I to Phase II.

Gain insight into why early toxicology readiness and strong scientific collaboration with CRO partners are critical to accelerating trial startup and regulatory approval.

Capturing insights from clinical research professionals on the key trends and challenges shaping drug development today, from those in clinical trial operations and site relationships, to technology and AI, and the evolving regulatory and policy terrain.

In this episode of the ACT Podcast, we highlight a recent Q&A featuring Ibrahim Kamstrup-Akkaoui, vice president of data systems innovation at Novo Nordisk; and a feature article by Chris Driver, senior director of product management, Patient Suite at IQVIA, in which they both highlight how sponsors are adopting automation to streamline operations.

Gain insight into how listening to site feedback and prioritizing engagement, training, and local patient understanding can drive smoother startups and stronger study outcomes.

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.

Discover how reducing redundancy in feasibility processes and leveraging shared databases can improve collaboration and ease site burden.

In a breakout session at the 2025 SCRS Global Site Solutions Summit, industry leaders from SCRS, QCR, and Syneos Health discussed how sites can prioritize patient empowerment, strengthen community outreach, and collaborate with CROs and sponsors to secure resources for engagement initiatives.

Interviews with biopharma leaders and outsourcing partners reveal emerging trends in clinical trial resourcing models, highlighting a shift away from traditional full-service CRO arrangements toward hybrid strategies that balance in-house expertise, trusted consultants, and selective outsourcing.