Improving access and reimbursement for specialty therapies
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.
The differences between the US and EU biosimilar markets
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.
How to ensure your trial data and patients remain safe during COVID-19
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.
The impact of COVID-19 on pharmacovigilance
COVID-19 is affecting how clinical trials are managed, in terms of patient recruitment, patient care, data collection, analysis and safety reporting.
Wearables and digital endpoint generation
The key considerations that arise when using digital technology to support endpoint generation in clinical studies.
The shifting diagnostics regulatory landscape amid COVID-19
For IVD manufacturers, the emergence of a novel virus is challenging as the detection of such viruses require quickly developed, novel diagnostic solutions.
Five common literature reviews for RWE generation
In the evidence-based era of medicine and decision-making, literature reviews offer a faster and more cost-efficient method to gather intelligence.
Diagnostics on the frontlines of COVID-19
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.
The importance of formulation studies in drug development
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 vaccine trials
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.
COVID-19 and respiratory devices: A dynamic market and evolving regulations
The respiratory devices market is witnessing enormous demands across the globe, resulting from the increased need for ventilators due to rising COVID-19 cases.
Minimise the impact of COVID-19 on clinical trials with in-home clinical services
ICON's In-Home and Alternative Site Clinical Solutions teams continue to review support to clients, sites and regulatory agencies to reduce the impact of COVID-19.
Parkinson’s disease clinical trials: Challenges and the role of technology
The human brain is probably the most complex structure in the universe. It is therefore not surprising that clinical trials for CNS diseases pose various challenges.
Managing trial participants with cardiovascular and metabolic disease during COVID-19
The COVID-19 pandemic is of particular concern for cardiovascular and metabolic trials because the subjects recruited are typically older with underlying cardiovascular disease and/or diabetes.
Digital intelligence for the clinical trial: How the IoMT is streamlining clinical operations
Rapid progress in connectivity and technology is inspiring innovative clinical trial design.
COVID-19, Influenza and cardiovascular disease - What is known?
Increasing evidence supports that influenza infections can be a trigger for acute myocardial infarction (AMI) and stroke.
Preparing for Disease X, a look at the potential impact of Coronavirus
The international response to Coronavirus is focused on a number of key steps; containing the disease, saving the lives of those infected and developing vaccines.
Immunotherapy in cancer treatment
Immunotherapy has been the focus of medical research for many years, and scientists continue to experiment with and learn about the form of therapy in cancer treatment.
Changes in clinical safety reporting to the FDA
FDA has upgrade the Investigational New Drug (IND) safety reporting from paper eCTD format to E2B format, improving potential safety signals in clinical studies.
Healthcare resource use and costs in AML patients
The objective of this study was to estimate the cost of treatment-resource use and costs associated with sick leave (SL) and early retirement (ER) in patients below the age of 60 years with AML.