Highly manual processes, specific local market requirements, and tool usage inconsistencies have impeded global information visibility and flow, adding risk to key regulatory processes. More…
With the end of the year quickly approaching, you will likely see multiple articles on the key trends of 2023 and predictions for 2024 start…
Despite a step change in awareness about the need for diverse participants in clinical trials, ongoing clinical trials in western health systems fail to reflect…
The long-awaited eCTD 4.0 standard is now available, though it is not yet mandatory. Life sciences companies can tap into the detail of the standard…
Achieving regulatory excellence depends on a combination of optimisation processes, effective global systems, high data quality, and enhanced affiliate collaboration. However, transforming information management at…
These days, clinical trials are in the news pretty much daily. Whether successful or not, they can impact not only the perception of a pharmaceutical…
Patient centricity and engagement demands that associated technology is developed in a way that research activities are aligned with the patient’s lifestyle. To do this…
As well as exposing companies to non-compliance, inefficiency and delays, a manually-maintained pharmacovigilance system master file (PSMF) limits visibility and transparency. Christian Schmitz-Moormann, a senior…
The pharmaceutical manufacturing and life sciences industry is in a state of significant disruption, and subsequent transformation. The fallout from COVID, combined with supply chain…
Throughout the 2020s, pharmaceutical companies have been thrust under the spotlight like never before. Fortunately, they’ve largely responded exceptionally, delivering life-saving vaccine treatments at record…
