Latest Articles
The ICH E2B(R3) Deadline Is Here: What Small Biotechs Need to Know About ICSR Intake
The mandatory FDA deadline for electronic ICSR submissions is no longer on the horizon. Here is what IND sponsors need to do right now, starting with adverse event intake.
Read article →MedDRA Coding at Intake: Why AI-Assisted Triage Belongs Upstream of Your Safety Database
The case for moving MedDRA coding to the intake form, with the validation framing your QA group will sign off on.
The Drug Safety Inbox Is Not a System: What Small Biotech AE Intake Actually Looks Like in 2026
A description of the operational reality at 30-person biotech sponsors, drawn from team experience inside biotech PV programs and 72 conversations over the past quarter.
AE Connect vs. Argus vs. Veeva Vault Safety vs. Reportum: A Buyer's Guide for Pre-Commercial Biotech
Honest comparison of four pharmacovigilance platforms for small biotech. What each was built for, where the price points land, and where the operational fit breaks.
Adverse Event Intake vs. Full Pharmacovigilance: What Is the Difference?
Understanding where AE intake ends and full pharmacovigilance begins, and why the distinction matters for small biotech program design.
Why Veeva Vault Safety and Oracle Argus Are Overkill for Early-Phase Biotech Programs
A practical look at why enterprise PV databases are designed for large MAHs, and what small IND sponsors actually need instead.
The Missing Layer in Pharmacovigilance: Why Adverse Event Intake Has Been the Blind Spot
Enterprise databases handle case processing. Spreadsheets handle intake. That gap is where compliance risk lives, and where AE Connect was built to operate.
Building a Pharmacovigilance Plan for Your First IND: What Small Biotechs Get Wrong
Most first-time IND sponsors treat the PV plan as a template exercise. Here is what regulators actually expect and where small biotech programs consistently fall short.