Life Sciences

Listening in to healthcare consumers

The patient has always been a “consumer” of healthcare and life sciences services, but something has changed — to an exponential degree — in recent years. The rapid growth of digitalization and mobile connectivity, coupled with the increased expectations of digital natives, has rapidly moved healthcare and life sciences communications into the next generation. Historically, the patient […]

Preparing for the “Soft” Side of Cloud Transitions

We tend to give a lot of consideration to the technology and infrastructure aspects of moving to the cloud, but we often overlook the human element. As life sciences companies begin the journey of transitioning from legacy systems and infrastructure to a fully managed cloud service, they need to consider how best — and how […]

How Ready Are You to Respond to Heightened and Converging Submission Demands?

The pressure on life sciences companies is unrelenting. Not only must they find ways to speed up development, but they also need to hasten and improve the submission process. Clearly, getting your drug or product through the approval process as quickly as possible is in your best interests, as well as those of your patients. […]

Confronting the Winds of Change Across the Life Sciences Value Chain

The life sciences industry is up against some intense headwinds: declining market access, patent expirations, rising research and development (R&D) costs, pressure to ensure patient access; reimbursement barriers; and ever-increasing regulatory demands. Countering those challenges, however, are some exciting developments, such as growing global demand for healthcare opportunities in emerging markets alongside advances in medical […]

The Unknown Unknowns of Product Labeling: Are You Compliant?

Are you compliant? That’s a question that keeps regulatory affairs executives up at night, particularly in light of increased responsibilities and prosecutions. Where this question becomes even more difficult to answer is with labeling, since this is an area that traverses so many parts of the enterprise. Among the factors regulatory affairs must contend with […]

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, […]

From Ad Promo to RPS – DIA Turns Focus on Being Prepared

Changing submission requirements come thick and fast for life sciences companies, putting regulatory departments under continuous pressure to stay one step ahead. There are a number of issues such departments will have to tackle now and in the future — from new electronic Common Technical Document (eCTD) requirements to the adoption of new standards. By […]

Transforming the Regulatory Environment Through as-a-Service

The cloud is gaining huge ground across all industries as companies seek greater flexibility and reduced costs. Cloud can transform the way life sciences companies maneuver the changing regulatory landscape. But putting an as-a-service or cloud solution in place requires careful consideration, including identifying the stakeholders, defining your reason and goals, establishing a clear plan, […]

From Small to Large: Getting the Most from a BPS Engagement

The submission management needs of companies vary significantly, particularly when it comes to size of the company. Deciding to work with a business process services (BPS) partner to implement agile workload management practices, therefore, should take those different requirements into account. By Marcy Miller, Principal, Regulatory Solutions and Services, DXC A small company with few […]

Providing Clean Datasets: The Benefits and Challenges of SDTM

There’s no doubt that the data standards body Clinical Data Interchange Standards Consortium (CDISC) has benefited both industry and regulatory authorities by standardizing the management of clinical trial data. But it’s fair to say that significant complexities are involved in converting data to the CDISC standards. By Han Zou, Manager, Biometrics and CDISC, DXC Let’s […]