Unlocking the Advantages of eCTD 4.0 Compliance
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…
ePharma
Enhancing Local Affiliate Engagement to Drive Dynamic Global Regulatory Processes
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…
The Problem with Clinical Trials (and how virtual insight-gathering can help)
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-first Technology Development Increasing Patient Centricity
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…
Digitising Pharmacovigilance System Master File Management
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…
Pharma’s Missed Opportunity: Innovations we must Embrace to stay Competitive
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…
How Pharma Companies can Accelerate Customer Engagement Post-pandemic
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…
Ensuring End-to-end Quality and Safety through Third Party Supplier Management
With disruption to the traditional supply chain, managing quality and safety in today’s complex and ever-changing global Life Sciences market can be a challenge. In…
Achieving Statistical Significance when Global Patient Populations are Limited
Highlights of a recent panel debate moderated by Christian K Schneider, head of Biopharma Excellence, which explored emerging approaches to clinical research and data collection…
The Post-pandemic Life Sciences Sector: Leveraging Data Strategies to Improve Patient Outcomes
The Life Sciences industry has faced unprecedented challenges in the wake of the pandemic. 2023 is set to be a crucial year when companies must…