Pharmaceutical, Biotech & Life Sciences Information Reporting Compliance Assessment

What this assessment covers

Pharmaceutical manufacturers, biotechnology companies, medical device manufacturers, diagnostics companies, and contract research organizations (CROs) share a common information reporting risk profile: payments to health care professionals (HCPs) and key opinion leaders (KOLs), royalty and licensing payments, clinical trial and research subject payments, and a heavier-than-average volume of foreign payees. Rather than treating foreign payees as a separate topic, this assessment builds Chapter 3 withholding and Form 1042-S questions directly into each payment category below, alongside the corresponding domestic questions. This assessment evaluates your organization's readiness across all seven risk areas below.

HCP & Royalty Payments

Consulting, speaking, advisory board, and IP royalty payments to both U.S. and foreign HCPs and licensors — the $10 vs. $2,000 threshold distinction, the Box 6 misapplication risk unique to this industry, and Chapter 3 withholding / Form 1042-S for foreign payees

Clinical Trials & Distribution

Research subject and investigator payments (U.S. and foreign), CRO-administered payment filing responsibility, and correctly excluding goods/rebate payments from 1099 reporting

TIN Matching & Backup Withholding

TIN matching, B-Notices, and 24% backup withholding controls applied across HCP, royalty, clinical trial, and vendor payee populations

IRIS & State Reporting

FIRE-to-IRIS filing transition across multiple source systems, plus state threshold conformity and filing format requirements

Each section can be marked not applicable if your organization has no obligations in that area. Results include statutory citations for every gap identified.

Assessment Results — Pharmaceutical, Biotech & Life Sciences

InfoReporting Solutions · Results based on self-reported responses