11.20.25 -- What Can We Expect From The FDA In 2026?

Learn how to identify common CRO selection pitfalls and apply expert-backed strategies to protect your clinical program from costly risks and delays.

Discover the expertise of a chosen clinical supply partner as a valuable resource. Examine key considerations when partnering with a CRO in order to deliver a successful clinical supply strategy.

Drug development accelerates with AI, decentralized trials, and adaptive protocols, but legacy CRO infrastructure lags. Platform-based systems enable speed, quality, and continuous improvement.

Leveraging incurred sample reanalysis (ISR) in your quality control helps your team mitigate risks, establish regulatory compliance, and instill confidence in your pharmacokinetic modeling.

Gain insight into the evolving landscape of immune-based drug development and best practices CROs should adopt to overcome its unique challenges.

Explore examples of smarter SAD/MAD trial designs including multi-part and hybrid protocols, regulatory foresight, recruitment considerations, and operational strategies that keep programs moving.

Specialty oncology CROs bridge the gap between traditional CRO operating models and the specialized needs of oncology sponsors by embedding deep oncology expertise across every function.

Explore how SGS's Hudson facility can enhance your drug development process by providing cutting-edge bioanalytical testing solutions and seamless global support.

Understand how free trade zones work, and explore a flexible and cost efficient way to supply clinical trials in China and around the globe.

Choosing the right vendor at trial launch impacts costs, timelines, data integrity, and patient experience, yet vendor selection in clinical research remains fundamentally broken today.

What services are available to help you ensure continuous functional coverage, enhancing business continuity, operational efficiency, and risk mitigation?

As a full-service CRO, Southern Star Research has the knowledge, industry relationships and technical expertise to get your early-phase clinical trial up and running safely and efficiently.

As your product transitions from clinical phases to commercial launch, flexible, globally compliant facilities stand ready to adapt to your evolving needs.

This presentation outlines the key success factors driving high-impact oncology drug development, with a focus on translating innovative science into clinically and commercially meaningful outcomes.

As the U.S. FDA is impacted by layoffs that threaten its oversight capabilities, the importance of robust software and manufacturing process validation has never been more critical.

This 2024 Industry Pages report provides an in-depth examination of the Central and Eastern European (CEE) clinical trial strategy, highlighting its pivotal role in global drug development.

The current U.S. deregulatory momentum should not diminish compliance standards but instead serve as a call to streamline and modernize regulatory guidance.

For rare diseases, scientific breakthroughs often stall before reaching patients. A new approach to generating clinical evidence could change that trajectory.

As biomarker-directed therapies drive advancements in the oncology space, experts are reviewing cutting-edge trends and strategies that help institutions address ethical and regulatory challenges.

As one of the world’s largest and most experienced safety and PV organizations, unearth how this provider is bringing extensive expertise and regulatory intelligence to every industry engagement.