October 19, 2022 For several years, the U.S. Food and Drug Administration (FDA) and the life sciences industry have collaborated to develop guidelines for improving quality best practices in validating computer systems and harmonizing with international standards. The FDA’s release of the CSA...
June 6, 2022 Although data and knowledge of the disproportionate application and access to health amongst minority populations are well known, data regarding the impact of the virus on exacerbating health disparities wasn’t immediately available.
February 4, 2022 Picture it - it’s been years since your vision of bringing a new therapy to market was set in motion. The team was small with an immediate focus on the product development stage. As the clock ticks away, the clinical...
Complex therapies require close patient engagement and support along their treatment journey. Digital support tools at critical inflection points can help the patient feel empowered and cared for. We help you find those critical points and design digital assets to...
As biopharma organizations begin to see positive clinical data and regulatory feedback to indicate the potential of a product launch, their biggest challenge is transitioning from a pure R&D organization to a commercial entity. Suddenly there is a ramp-up of...
Product launches are one of the most complex programs for life sciences companies, especially for emerging biotech's bringing their first product to market. Let us help ensure your one opportunity for a successful launch. In addition to the complexity of...
September 13, 2021 I’ve been having a lively debate with a few of my colleagues about the digital value chain: a holistic view, of how technology enhances, connects and integrates the entire organization to deliver superior customer outcomes. We’ve been trying to pinpoint...