From venture-funded biotechnology and genomics startups to commercial-stage pharmaceutical and diagnostics companies, all must comply with a host of regulations designed to protect patient safety, safeguard the privacy of personal health information, and provide greater transparency. Moreover, the compliance landscape is not static, with ongoing rule changes that challenge organizations to continually evaluate and update their processes and controls to avoid falling out
of compliance. This reality has placed ever-more responsibility on the shoulders of corporate compliance o?icers.
At the same time, the role of information technology within the life sciences industry has continued to expand. IT systems, applications and networks are inextricably woven into the fabric of life science organizations of all stripes—from researchers to pharmaceutical manufacturers to medical device makers. All rely on IT systems and data to facilitate everything from clinical trials and R&D to product commercialization and customer support. This compounds the complexity of the compliance challenge.