Getting to the Hub of the Matter: Analyzing the Compliance Needs for Hub Services

By Thomas Sullivan Last updated May 5, 2018

Within the pharmaceutical industry there are new operating models emerging. One form of emerging arrangement is the increasing use of “hub services.” This article explores the breadth and variety of hub services and arrangements and the many challenges in ensuring appropriate compliance oversight created.

In compliance circles, we’re sometimes overly consumed with fighting yesterday’s battles. Compliance programs are often oriented toward the conduct behind the headlines of an old enforcement action or carrying out procedures prescribed in someone else’s corporate integrity agreement, which may itself be several years old and based on conduct that took place a decade or more before that. The real challenge lies in recognizing and managing what’s coming down the pike. This is especially true in the life sciences industry as the new economic, clinical, public policy and regulatory environment is generating new operating models and novel arrangements that were not common a few years ago.