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.
Innovation in Oncology Drug Development
Significant progress has been made in our understanding of the molecular lesions responsible for tumor cells to exhibit uncontrolled growth.
Top Five Digital Technologies Set to Transform Pharma R&D
The current wave of emerging digital technologies offers an opportunity to significantly disrupt pharma business operating models in a variety of ways.
The Impact of Digital Technology on Patient Engagement in Clinical Trials
The use of digital technology in clinical trials is creating more convenient, engaging and innovative treatments for patients.
Payers Report that ICER Analyses Increasingly Guide US Price Negotiations
According to a survey conducted by ICON in July 2019, prescription drug cost effectiveness analyses by the Institute for Clinical and Economic Review (ICER) are playing an increasingly important role in price negotiations.
Four Challenges to Successful Rare Disease Drug Development
Overcoming these challenges can greatly improve chances for a successful rare or orphan drug trial.
Harnessing Big Data: The raw material of digital transformation
The integration and mastery of digital technologies is becoming essential to improve the efficiency of clinical trial operations.
Challenges and Advances in NASH Clinical Trials
NASH is massively under-diagnosed, partly because it is a silent disease and partly because definitive diagnosis is by histopathology of a liver biopsy with associated risks.
MDR / IVDR Regulatory Roundup
Less than one year remains before the European Union’s new Medical Device Regulation (MDR) goes into effect on May 26, 2020, and only about a fourth of medical device companies plan to be fully complaint,