Blog

As the UK’s transition period to leave the European Union (EU) rapidly comes to an end, the Medicines and Healthcare products Regulatory Agency (MHRA) recently published new guidance on how it will regulate medical devices starting in January 2021.

The COVID-19 pandemic has not only impacted access to healthcare, but also significantly disrupted the conduct of clinical trials investigating therapies intended to treat cardiovascular (CV) diseases.

As procedures typically carried out on-site continue to be managed remotely, sponsors will need to implement a remote clinical trial management strategy to mitigate further roadblocks that may arise and keep clinical trials moving forward.

Over the past several years, regulations for the medical device industry have continued to evolve placing more emphasis on clinical data and patient safety.

Utilising data from sensors, wearables and other digital health technologies can provide critical information on COVID- 19 related symptoms and identify digital biomarkers in real- time.

With 350 million people affected worldwide, rare diseases represent a major unmet medical need. However, the timely recruitment of eligible participants is a challenge for any rare disease clinical trial.

The COVID-19 pandemic forced the clinical trials industry to accept and accelerate the use of digital health technologies.

Real world data offers an alternative approach to observational research, particularly to inform decisions on patient needs and preferences.

This blog is a condensed version of an ICON employee’s’ personal journey of courage and endurance.

In a recent podcast interview, ICON experts discuss the intricacies of CGT development, the solutions that will enable CGT development on a global basis, and the future of CGT clinical trials.

Clinical development can better satisfy the evidence needs of payers, and not incorporating the needs of payers early into trial designs risks the need to spend more money later on.

Biosimilar uptake in the US market has, until now, stood in stark contrast to that in the EU, which has led the way in biosimilar approvals and use since 2006.

The COVID-19 pandemic has presented an array of cybersecurity challenges. With no slowing down of the virus’s spread, hackers and other cyber criminals are continuing to seize opportunities to take advantage of vulnerable networks.

COVID-19 is affecting how clinical trials are managed, in terms of patient recruitment, patient care, data collection, analysis and safety reporting.

The key considerations that arise when using digital technology to support endpoint generation in clinical studies.

For IVD manufacturers, the emergence of a novel virus is challenging as the detection of such viruses require quickly developed, novel diagnostic solutions.

In the evidence-based era of medicine and decision-making, literature reviews offer a faster and more cost-efficient method to gather intelligence.

As the COVID-19 crisis continues to unfold, there is an immediate need for rapid diagnostic testing to identify and track people infected by or exposed to coronavirus.

Formulation studies require time, money and expertise, and the race to clinic and beyond may tempt drug companies, especially smaller ones, to take shortcuts that end up costing more later.

COVID-19 studies require new approaches to monitoring beyond the standard remote and on-site visits. This might include data analytics and remote monitoring using technology.