Getting the analytics right for GDPR compliance – and beyond

The challenges of complying with the European Union’s new General Data Protection Regulation (GDPR) are clear: Every organization serving customers in the EU — including organizations outside the EU that offer goods or services to individuals within it — will need to comply with new data privacy rules by May 2018. The clock is ticking, […]

Assessing your next move: How to ensure cloud is right for you – Part 4

Over the past couple of months I’ve spoken in some depth about important considerations before going to the cloud. Many of these are priorities that are top of mind for life sciences companies. But perhaps your first question should be, “Is the cloud right for me?” While there is broad assumption that the cloud is […]

Thinking Long-Term: RIM’s Transformative Possibilities Akin to the Advent of eCTD

The concept of a company-wide regulatory information management system – or what we call Intelligent RIM – may be somewhat perplexing to many users. They may well question why you would want your regulatory systems talking to you CMC systems and your clinical systems. My experience in speaking with clients in the industry is that […]

Module 1 Changes Bring Marketing and Regulatory Closer, But Disparities Need to be Managed

Last month some of my colleagues and I attended the DIA’s annual eRegulatory and Intelligence Annual Conference. It was an opportunity to hear about regulatory developments and talk to thought leaders about the changing regulatory environment. On the afternoon of day 1, senior FDA staff members offered an update. In particular, I’d like to focus […]

Why Capital-Efficient Innovation Is About More than Software: A Hands-on Experience

  The world as the life sciences industry once knew it has changed completely. Companies are facing new pressures to get more innovative drugs to market faster and at lower prices. This is driving an increased need for capital-efficient innovation that for life sciences is about developing innovation strategies that address key areas, such as […]