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. […]
By Sadia Ahmed and Marcy Miller The days of throwing money into research without clear objectives and goals for getting to market are gone for most life sciences companies. Today, the pressure is on to cut costs and to find ways to bring drugs to market — and to the patients who need them — […]
By Sharad Khusal A new, connected dynamic is making its way into the life sciences and healthcare industries, shifting companies from a traditionally siloed approach to an integrated 3.0 environment. Here the emphasis is on a healthy outcomes ecosystem — one that spans nontraditional players such as IT, retailers and nonprofit organizations. At the heart […]
by Sharad Khusal The life sciences business model is changing. In the past, companies typically worked with fewer partners, most often collaborating only with the physician, or indirectly, with patients. That later expanded to liaising with academia and the contract research organizations (CROs) directly affiliated with them. Today, those walls have come down and pharmaceutical […]
by Gireesh Gaonkar As a medicinal product moves from R&D into approval and manufacturing, it must deal with a complex and dispersed distribution network and a global network of manufacturing sites, some of which may be using old, noncomputer numerical control-enabled (non-CNC-enabled) machinery. Advances in technologies and the digital value chain create new pathways for […]
