DXC on Life Sciences

News, trends and technology insights for the life sciences industry

Putting OMS to the test: an account of the first phase of IDMP implementation

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 […]

Enhanced new functionalities underscore the power of DXC publishing portfolio

Meeting eCTD obligations in multiple countries is a major priority for life sciences companies. There is a need to understand the different regional requirements and validation criteria while at the same time ensuring any solution fits with the organization’s global systems and user requirements. With the latest version of eCTDXPress and Publisher, DXC Technology has […]

Putting efficiency and automation in the hands of ToolBox users

Efficiency, the ability to save time with necessary document processes, and ease-of-use are always top priorities for life sciences teams. Let’s face it, when you’re reviewing a document, the last thing you want is to deal with a lot of manual processes. Digitization and automation are making it much easier to create processes that make […]

The role of the project manager in defining strategic partnerships

Partnerships and business process outsourcing are integral to how the life sciences industry manages its regulatory activities today, but often those relationships can become mired in confusion about roles and responsibilities. In my last blog, I addressed the move from transactional to strategic partnerships. I’d like to address a key element in that relationship: the […]

Ahead of the Game: Preparing for SEND Format for Biologics Before It Becomes a Requirement

The concept of Clinical Data Interchange Standards Consortium (CDISC) standardization has become familiar to most companies. Biopharmaceutical companies must now submit both nonclinical and clinical data in CDISC formats to the Center for Drug Evaluation and Research (CDER) for all new drug applications (NDAs) and abbreviated new drug applications (ANDAs). While the same is true […]

Why Life Sciences Companies Are Moving from Transactional to Strategic Partnerships

The nature of the partnership between life sciences companies and regulatory process providers has changed significantly over the past decade, moving steadily away from one-and-done deals to long-term relationships. The advent of electronic Common Technical Document (eCTD) in 2002 resulted in sponsors seeking support from vendors as they struggled with such a new concept. For […]

What does end-to-end really mean: Unravelling industry claims

The 2017 DIA meeting in Chicago, which took place from June 18 to 22, witnessed a fair amount of buzz around Regulatory Information Management (RIM) solutions on the market that are being referred to as “end-to-end.” But what does end-to-end actually mean? And how does this term — and how it is used — resonate […]

Putting China on the global map with regulatory standardization

China has been making significant strides to become a global pharmaceutical force. A massive breakthrough came in June 2017 when the country was accepted as a member of the International Council for Harmonization (ICH), joining the global club that consists of the United States, Europe, Japan, Canada, Switzerland, Brazil and Korea. Chinese pharmaceutical companies are […]

Leveraging Digital Innovation for Efficiency, Productivity and Insight

The digital and automation age is upon us and life sciences companies have enormous scope for process improvement by tapping into new capabilities. More effective use of resources and improved outcomes are key drivers for life sciences companies. These goals can be achieved through using better analytics to derive greater insights from regulatory data, bringing […]