All articles by Miranda Mclaren
Miranda Mclaren
How quality clinical monitoring oversight ensures the success of clinical trials
High-quality monitoring and trial oversight procedures are essential for avoiding the serious consequences that come from protocol deviations, poor data quality, and regulatory issues.
Evaluating the top five sterilisation techniques for parenteral packaging
Patient safety should be top of mind in every drug-packaging operation, and the use of validated methods for sterilising primary packaging components before aseptic fill-and-finish plays a critical role in achieving this goal.
Analytical testing: Ten questions that accelerate drug development
When it comes to drug development, there’s no substitute for speed.
Is patient recruitment out of control?
Every year, the patient recruitment landscape is getting larger and more multi-faceted. The good news is that sponsors now have a wide range of options at their fingertips; the challenge is that it’s becoming harder to oversee the flow of patients and understand what is and isn’t working – and therefore hard to make meaningful decisions that improve the trajectory of recruitment for your trial.
Scaling up RNA-LNPs: Strategies for successful and consistent clinical manufacturing
While things may have slowed down a little since the rapid approvals of the COVID-19 vaccines, the excitement around RNA-LNP is still going strong. We spoke to nanomedicine experts at Precision NanoSystems to understand the process development and manufacturing challenges that lie ahead of companies approaching the clinical phase, and how the right partnerships can work wonders.
Will mobile visits help the clinical trials industry meet its diversity goals?
Lowering barriers to participation could boost the diversity of patients in clinical trials. We analyze gender, race and ethnicity data to understand the differences that mobile visits from a certified mobile research nurse can make.
Mobile health strategies: Should you build or partner for success?
With GlobalData figures showing the value of pharma’s 2023 digital therapeutics-related deals to have grown by 129% since 2018 [1], and the year still not out, it is clear that projects such as companion apps are becoming an increasing priority for life science firms. Here, we debate the benefits of building versus partnering, and share some important considerations for a successful project.
Launching pharmaceuticals in Belgium, the Netherlands, and Luxembourg: Opportunities and challenges
Benelux offers much potential for companies distributing innovative medicines, but they may need to surmount hurdles such as the region’s complex and lengthy reimbursement systems.
Overcoming disruptions in the pharmaceutical supply chain
Recent years have highlighted serious vulnerabilities in the pharmaceutical supply chain. With the COVID-19 pandemic now over and supply chains slowly but surely returning to normal, we interviewed Datwyler’s Gabrielle Gehron to understand the best sourcing strategies for primary packaging.