News, trends and technology insights for the life sciences industry
by Jared Kimble Now that we are entering into a new phase of discovery, the Identification of Medicinal Products (IDMP) has once again become a priority for the European Medicines Agency (EMA). After many delays and other scheduling problems, the industry must turn its attention to the standard but, rather than view it as just […]
by Jared Kimble Efforts to properly understand and deploy real-world evidence (RWE) are under way across the life sciences industry. Regulatory authorities and companies are assessing how best to make use of RWE and how to deal with some of the challenges that arise when managing large amounts of dispersed data. During the Drug Information […]
by Jared Kimble Value-based care is quickly becoming integral to the life sciences industry as the entire healthcare sector undergoes increased convergence. What that demands for pharmaceutical companies is better insight into the fair market value their products bring, or potentially will bring, to maximize all the benefits of those products. From a commercial viewpoint, […]
by Martin Bolden Spend analytics information has traditionally been closely guarded by procurement. But this approach is arguably a lost opportunity for both procurement and the wider business. Spending decisions are regularly made by other functions, so for a business to derive the best value and outcome from those decisions, spend analytics information must be […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]