Whitepapers

All emerging biotechs face a similar challenge: they’re expected to build pharmacovigilance (PV) infrastructure that meets the same regulatory standards as large pharmaceutical companies, but

Sponsors and contract research organizations (CROs) have depended on each other for more than 30 years to bring therapies to market. But the relationship has

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