How regulatory intelligence leads to real-time strategic decision making

by Jared Kimble Data is all around us. It’s created with everything we do. For the life sciences industry, this means data is being collected faster and at a greater rate than ever before. Data takes the form of structured content — from clinical trials, regulatory filings, manufacturing and marketing, drug interactions and real-world evidence […]

Speed and efficiency: The role of automation in an increasingly eCTD world

By Sadia Ahmed and Marcy Miller, DXC Life Sciences The world of the electronic Common Technical Document (eCTD) is closing in on life sciences companies, irrespective of size. The U.S. Food and Drug Administration (FDA) now requires the use of eCTD for all New Drug Applications (NDAs), Abbreviated NDAs, and Biologics License Applications (BLAs), and […]

Regulatory submissions in a digital world

By Jeanie Kwon and Leslie Wan, DXC Life Sciences Digitization of the regulatory platform has conferred significant benefits for life sciences companies, but it has also brought new challenges, since our industry is heavily governed by standard operating procedures and validated systems to meet regulations. Add to regulations, global language barriers, entrenched ways of working […]

Getting an Early Start: Taking a Holistic Approach to Product Labeling

When pharmaceutical companies think about labeling, the assumption is that it begins with the marketed product. So the focus has typically been on managing the labeling text for post-marketing activities — artwork, packaging, etc. But it’s during the clinical trial phase that the company core data sheet (CCDS) should be developed and then updated periodically, […]

Five Steps to True Client-Vendor Partnership

So, you’ve decided to use a business process service (BPS) as part of your regulatory information management activity. Whether it’s to supplement your internal activities to deal with peak workloads, or a strategic shift to outsourcing, establishing and maintaining good vendor relationships is vital to achieve cost benefits, gain efficiencies, and drive quality and customer […]

Removing Cost While Retaining Best Practice: Content Management for the Future

Operational costs are in the crosshairs of life sciences companies. The challenges they face in an increasingly tough commercial environment not only means a shift in required longer-term strategic thinking, but also a focus on operational costs. Many are now looking at their overhead and the costs of their legacy systems to assess how to […]

Industry Change Raises the Need for a Broader Perspective

The life sciences industry is undergoing significant change on all levels – in terms of business model, global regulatory developments and management of processes. All of these changes pose both opportunities and challenges for companies, prompting them to consider what activities they should manage internally, how and where they should partner and how they should […]

Predictive Analyses: How Compliance Could Lead to a Leap Forward

The looming IDMP regulatory changes are predicted to force organizations to harmonize their data across their internal silos. Some will invest in these pre-eminent upgrades by planning early and architecting a solid cross-silo master data entity model, which could springboard their respective organizations forward and help to improve business processes, improve business intelligence, and exploit […]

A Seamless Generation

Next-gen technologies are making significant inroads into life sciences by seamlessly integrating into infrastructure. By John J. Bell, Industry General Manager, CSC Life Sciences A recent CIO Survey proves it’s time for CIOs to grab the reins and become disruptive innovators, leaders who are willing to take a few calculated risks to integrate next-generation technologies […]

Secure in the Cloud: What You Need to Know About the Cloud Before Taking the Plunge – Part 2

As the life sciences industry is discovering, the cloud presents many opportunities for improvement enabled by fast deployment, delivery and scaling of IT resources, but that doesn’t detract from some nervousness – whether valid or not. By Dawn Waite, Manager, Life Sciences in the Cloud In my last blog I spoke about concerns over validation […]