Life Sciences

China gets ready to launch eCTD, as companies face a challenging learning curve

by Winnie Yang and Leslie Wan China is gearing up for the implementation of electronic Common Technical Document (eCTD) submissions to accelerate the review and approval of new pharmaceuticals. A year after officially introducing the subject, the life sciences industry in this country is starting to see greater momentum toward implementation. Publication of official specifications […]

Connected healthcare: Why mobility matters to the clinician

Doctor Using Cell Phone in Hallway

by Dr. Shainal Nathoo Technology experts will often talk about the benefits of mobility in healthcare, but to understand why mobility matters and how it might improve both workflow and clinical benefits for patients, it’s vital to get a user’s perspective. As a clinician, my view of mobility is influenced by my own experiences in […]

Reimagining patient centricity and healthcare practitioner engagement for 2020

by Satish Pandelenghat and Manjunath Shanabag The relationship between the life sciences industry and healthcare practitioners has changed dramatically in recent years. It wasn’t that long ago that sales reps visited each practice to provide information about new products. That changed in the late 1990s and early 2000s as information became more digital. Now what […]

4 considerations when choosing a solution for managing global regulatory submissions

by Dawn Waite and Sadia Ahmed There are so many balls in the air when managing global regulatory submissions that it’s all too easy to lose sight of the bigger picture. That picture really should be focusing on the portfolio, building your regulatory intelligence and strengthening your position in the market. But the day-to-day strain […]

Transforming pharma’s customer value chain with digital technologies

by Satish Nair and Manjunath Shanabag Pharmaceutical companies struggle with a complex and, often, poorly managed partner, customer and distribution network. It’s not surprising, given the makeup of most large pharma companies. Large, often disconnected product portfolios are built through discovery — both internally and externally with academia and biotech partners — and global clinical […]

Quantum computing will change everyday life for the better

Quantum computing is the next holy grail of computer science and engineering, promising to change everyday life for the better. Today’s smartphones have the same computing power as a military computer 50 years ago that was the size of an entire room. Yet despite the phenomenal strides we have made in technology and computing, there […]

AWS re:Invent opens eyes to possibilities from machine learning to security and storage

by Dawn Waite Technology as an enabler for innovation and process improvement has become the catchword for most companies. Whether it’s artificial intelligence and machine learning, gaining insights from data through better analytics capabilities, or the ability to transfer data and knowledge to the cloud, life sciences companies are looking to achieve greater efficiencies and […]

Uncovering efficiencies in clinical drug trials related to the trial master file

by William Hamilton and Gireesh Gaonkar How best to manage the trial master file is a subject of much debate for pharmaceutical companies. Is an electronic trial master file (eTMF) necessarily the right approach? Who are the stakeholders involved in managing the trial master file? And how do you ensure clear lines of accountability with […]

Price alert: What state transparency laws will mean for pharma companies

by Manjunath Shanabag and Satish Nair Pharmaceutical and biotechnology companies are under pressure to manage their complex pricing environment in the wake of new state laws on price transparency. These laws were passed to deal with ongoing concerns about the growing cost of healthcare in the United States. In response, state governments have been taking steps […]

What’s “atomic knowledge,” and how can it make pharmaceutical labeling easy?

by Jared Kimble The opportunity to transform the way pharmaceutical companies do business through digital technologies can be felt across the entire life cycle. One such area is labeling, which has long struggled with issues related to document ownership and control, maintaining accurate status, having a global view of the processes, reviews and approvals, and […]