All articles by Miranda Mclaren

Turbulent times: The impact of global crises on clinical trial teams

It’s 2025 and it appears that turbulence is now the new normal in clinical trials. From public health emergencies to…
IRT/RTSM: Key factors you need to know before choosing a solution for your trial

Melissa Peirsel is the Manager of IRT Services at Sharp and brings over 13 years of experience in clinical trial…
7 key questions to consider for your next IND filing

When preparing for an upcoming drug development program, leveraging existing knowledge and strategies to streamline the process from concept to…
Leveraging expedited programs in oncology: How accelerated approval helps drug developers get cancer drugs to patients faster

Introduced in 1992 as a response to the HIV/AIDS crisis[i], the FDA’s accelerated approval pathway has been instrumental in providing…
Why sponsors should be using community research in obesity and diabetes trials

The World Health Organization has called obesity “one of today’s most blatantly visible – yet most neglected – public health…

Clinical trial challenges in China: How a Sharp and ClinsChain pairing is breaking down barriers

The market for clinical trials in China is currently experiencing significant growth, driven by increasing activity from both Chinese sponsors…
Project Optimus: The evolution of dose optimisation in oncology

In 2021, the Project Optimus initiative was launched by the US Food and Drug Administration’s (FDA) Oncology Center of Excellence,…
Beyond compliance: The strategic role of PASS in rare disease therapy success

By taking a more strategic approach to PASS, you can secure long-term market access, gain regulatory trust, and provide critical…
Realising the opportunities for growth in the European orphan drug market

The European orphan drug market is growing and is already comparable in size and scope to the US market. The…
Orphan drugs: How to avoid costly stock losses in Europe

Estimates suggest that there could be around 300 million people worldwide living with a rare disease. A disease is classed as…

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