DXC on Life Sciences

News, trends and technology insights for the life sciences industry

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 […]

Where, When and How: Brexit Poses Many Questions over the Future Location of the EMA

As the United Kingdom prepares to leave the European Union, the pharmaceutical industry has been battling with uncertainty, particularly with regard to the impact on regulatory processes and market authorization of drugs. Exactly how Brexit will affect the industry remains uncertain, since the UK’s withdrawal from the EU is unprecedented. UK Prime Minister Theresa May […]

Taking the Complexity Out of Regulatory Governance in an Era of Digital Transformation

The fast pace of technology innovation and digital transformation has added another layer of complexity for life sciences companies trying to manage their regulatory governance and compliance. However, at the same time, business leaders need to embrace the digital transformation to create efficiency, drive competitive advantage, reduce costs and deliver business value beyond compliance. How […]

How IDMP May Be the Catalyst to Better Data and Resource Management via the Cloud

cloud DXC Blogs

Life sciences companies are assessing how best to respond to one of the biggest regulatory challenges they have faced in years: Identification of Medicinal Products (IDMP). The problem is that IDMP is a moving target, much remains unknown, and implementation of the standard will be done in iterations. From a systems and process point of […]

How Regulatory Transformation Drives Transparency and Data Access to the Whole Business

There’s a growing realization across life sciences companies that the regulatory function — how it is managed from an infrastructure point of view, how it is governed, and how the data within it is managed and tracked — needs to be consolidated. Increasingly, companies are looking to consolidate their distributed regulatory processes into a centralized, […]