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 […]
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 […]
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 […]
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 […]
by George Mathew MD, Rikin Patel and Paul Thompson Recent headlines have been full of news about major healthcare mergers and acquisitions, often involving newcomers to the industry, but also creating a convergence of traditional payer, provider and pharmaceutical benefit management companies. Here are some of the latest examples in the changing healthcare scene: CVS […]
by Jared Kimble Data is all around us. It’s created with everything we do. For the life sciences industry, this means data is being collected faster and at a greater rate than ever before. Data takes the form of structured content — from clinical trials, regulatory filings, manufacturing and marketing, drug interactions and real-world evidence […]
by William Hamilton Life sciences companies have long struggled with inefficiencies and inconsistencies with their trial master file (TMF) processes. Certainly, manual TMF processes leave many gaps and make it difficult for companies to maintain their clinical documentation sets, but this problem is not exclusive to manual processes. Even companies that have partially or completely […]
By Sadia Ahmed Life sciences companies are increasingly looking for better integration and interoperability across their various content management systems and improved oversight of regulatory content to address both compliance and efficiency demands. This is particularly important for regulatory publishing amid a push to improve both data quality and processes. While a content management system […]
By Jared Kimble The pharmaceutical industry has been anticipating the next stages of the FDA’s Drug Supply Chain Security Act (DSCSA) for some time now. The act, which became law in 2013, requires that trading partners in the supply chain – manufacturers, repackagers, wholesale distributors — and dispensers must meet product identification and traceability requirements. […]
