Life Sciences

Pharmacists on the front line in the opioid crisis

By Beth Slamowitz Pharmacists, who are considered among the most accessible and trusted health professionals, can answer questions about reducing the risk of overdose, what to do in case of an overdose and where to seek help with addiction management services. Pharmacists are the gatekeepers for prescription painkillers and play a key role in preventing […]

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 […]

A focus on transformation: User group meeting sets sights on the future

By Sharad Khusal, Global Head, Life Sciences Build Team, DXC The message for the life sciences industry is loud and clear: It must manage costs, demonstrate real-world value of its products, and find new ways to innovate and respond to customer demands. It was a discussion that resonated during the Life Sciences User Group meeting […]

Connecting the life sciences ecosystem to drive flexibility, efficiency and cost reduction

By Sharad Khusal The age of the life sciences silo is coming to an end. Increasingly, companies are recognizing the need for and even pushing for a connected ecosystem to manage the entire life cycle of a product. Companies don’t want their solutions to work in isolation — they want seamless integration between product management, […]

6 technology trends for 2018: Guideposts for digital transformation

‘Tis always the season for continuous innovation. As we look ahead to 2018, we see six big trends feeding the next wave of disruption and productivity. And that means opportunity for the digital enterprise. 1. Re-platforming the enterprise In 2018, companies will move to common IT platforms so they can respond to market changes faster […]

LEAN life sciences practices: A macro- and microresponse to document management

By Kim Dyrenius Life sciences companies are under pressure to cut costs and improve efficiencies across every part of the business. For an industry that is data dependent across the research and development (R&D) and the quality and manufacturing (Q&M) life cycles, cost cutting and efficiency have meant adopting LEAN principles when managing documents. Traditionally, […]

Tearing down those hospital walls: Electronic Health Records 2.0

Often in my working day I’m challenged to explain and defend technology’s relentless progress in medicine. Many healthcare and life sciences practitioners and managers say they feel threatened by digitalization – it’s complicated and even overwhelming, and there’s just too much at stake. The thinking goes like this: While it’s clear that digital transformation can […]

Putting OMS to the test: an account of the data management services that comply with the IDMP ISO standards

by Jared Kimble As planning for the Identification of Medicinal Products (IDMP) standards continues to make headway, the European Medicines Agency (EMA) has recognized just how large the job would be — both for itself and for industry. In response, it decided to break activities down into bite-size chunks, or iterations. On its side, the […]

Driving out complexity: efficiency and user experience top priorities in Viewer 4.0

As companies prepare their submission documents, a critical part of the process is document review. While it’s vital that these documents can be edited only by authorized stakeholders, many others involved in the process must be able to view and assess both archived and current electronic Common Technical Documents (eCTDs). How people view documents is […]