Featured News & Highlights

TORONTO – September 29, 2026 – Everest Clinical Research is pleased to announce that it has been…

TORONTO — September 17, 2026 — Everest Clinical Research (“Everest”), a data-first, full-service clinical research organization, today…

Over the years, our biostatistics and regulatory teams have supported hundreds of ISS and ISEs, giving us firsthand insight into the challenges sponsors commonly encounter. While many of these challenges are avoidable with the right planning and strategy, if left unaddressed, they can lead to significant rework and regulatory delays.

Experienced oncology teams know that successful country selection depends on much more than identifying where a study can start quickly. Here are four factors that can be under-considered when developing a country strategy for an oncology study in Europe.

Many sponsors and investors interpreted a recent FDA article as signaling a major shift away from the Agency’s longstanding expectation that two successful pivotal studies are generally required to support approval of a new drug. However, the reality may be more nuanced.

One of the more interesting themes emerging from ASCO 2026 was that some of the most important progress in precision oncology care is not about adding more/new treatment—it is about determining when less treatment is enough.

Over the last 10-15 years, the amount of time spent between clinical trials, including administrative closeout and key decision points, has significantly increased. A new initiative by FDA aims to reduce “dead time” between clinical trial phases.

Many sponsors encounter a consistent challenge: ADC clinical trials introduce a level of operational complexity that goes well beyond traditional oncology trials.

Historically used more frequently in exploratory analyses, Bayesian approaches are now increasingly recognized as viable frameworks for primary analysis in drug and biologic development—when appropriately designed and justified.