Premier Research

Drug development has always required decisions to be made in the face of uncertainty. Which dose should move forward? Which patient population is most appropriate? How should a study be designed to generate meaningful evidence?  For many years, those decisions have been shaped through a largely empirical and sequential process—where decisions are made primarily based on the data generated in the …

In clinical research, safety documentation plays a critical role in protecting participants and ensuring regulatory transparency. Among the many documents generated during a study, safety narratives and Clinical Study Report (CSR) narratives are often discussed together—and sometimes interchangeably, which can cause confusion. Despite sharing similar terminology, these two narrative types serve d…

Clinical development is entering a period in which acceleration and accountability are advancing in parallel. Study teams are operating in an environment shaped by evolving regulatory expectations, expanding data sources, and rapid innovation in analytics and automation. As a result, the industry is aligning around shared priorities: greater visibility into trial execution, stronger cross-functio…

As cell and gene therapies continue to reshape treatment for complex and rare diseases, clinical research teams are navigating new operational realities. As these therapies advance, development strategies are also evolving to address new operational, regulatory, and evidence-generation challenges. Unlike many traditional therapies, cell and gene therapies may persist in the body for years, result…

Recent regulatory developments are reshaping how sponsors think about evidence, oversight, and operational readiness. In a New England Journal of Medicine Sounding Board, FDA leadership announced that one adequate and well-controlled clinical trial — supported by confirmatory evidence — could become the agency’s new default standard for approval.i The shift formally moves away from the long-stand…

In our recent blog examining the FDA’s move toward a one pivotal trial approval pathway, we explored what this shift means for clinical strategy, regulatory engagement, and evidentiary rigor. As development programs concentrate approval decisions into a single adequate and well-controlled study, the implications extend well beyond protocol design and statistical planning.  If one study carries th…

In recognition of Women’s History Month, we spoke with two leaders who bring complementary perspectives to women’s health development: Kathleen Lemaitre, MD, FACOG, Executive Director in Medical Affairs and board-certified OB/GYN, and Stacey Ayres, PhD, Vice President, Regulatory Strategy. Together, they reflect on how women’s health research has evolved — and what it will take... The post Women’…

In February 2026, the Food and Drug Administration (FDA) outlined a meaningful evolution in the Agency’s evidentiary approach to drug approval: establishing one adequate and well-controlled trial, supported by confirmatory evidence, as the default basis for marketing authorization. This position was articulated in The New England Journal of Medicine in “One Pivotal Trial, the New... The post The …

Infant formula is an essential food product that serves as the sole source of nutrition for many babies in North America and Europe during their first year of life, supporting health, growth, and development.[i],[ii]  As manufacturers seek to bring new products to market or support regulatory submissions for existing formulas, infant formula clinical trials have... The post Accelerating Infant Fo…

Returning individual results to participants is gaining momentum as a core expression of patient-centered research. In rare disease development, where participants often contribute significant time, personal risk, and emotional investment, access to personal study data is increasingly seen as part of a respectful and transparent research relationship. When done thoughtfully, it reinforces trust, …

Antibody–drug conjugates (ADCs) are rapidly reshaping the oncology treatment landscape. By combining the targeting precision of monoclonal antibodies with the cytotoxic potency of small-molecule payloads, ADCs offer the promise of improved efficacy with more controlled toxicity. This potential has fueled unprecedented growth across the pipeline, with dozens of ADCs already approved and hundreds m…