Whitepapers

When the FDA published the ICH E6 R3 guideline in September of 2025, it illustrated how much clinical trials have changed over the last decade.

Managing clinical trial data is complicated and time-consuming. Teams must juggle thousands of queries, clean large datasets, and monitor sites for potential risks, all while

Pharmacovigilance has always been a crucial component of the biopharmaceutical industry, but it has become even more so over the last decade. During that time,

COVID-19 Summer Resurgence: What Biotechnology Companies Can Do To Prepare for the Next Pandemic Before COVID-19, many Americans associated the word ‘pandemic’ with movies and

Women account for nearly half the human population (49.6%), but are often excluded from clinical trials and medical research. Unfortunately, this lack of inclusion has

Preparing for ICH GCP E6 R3 The International Council for Harmonization’s (ICH) guidelines received a major update in 2023 with the introduction of ICH E6(R3).