Mapping digital health transformation: From digital endpoints to device selection
At ICON, our framework maps the transition from device selection to digital endpoint validation, leading to a better data management and risk mitigation.
Safety reporting in LATAM is changing, are you ready?
LATAM is evolving to electronic safety reporting and it is essential to be prepared for it.
Digital health technologies: Implementing innovation in cardiovascular studies during COVID-19
The COVID-19 pandemic has led to the implementation of more efficient trial designs and operational execution, especially with regard to cardiovascular (CV) studies.
Wearables across phases: How to best incorporate digital endpoints at every stage of clinical research
Once implemented properly, digital endpoints have the potential to enhance any trial, whether observational or interventional, or early or late phase.
New UKCA (UK Conformity Assessed) marking
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.
Reducing disruptions of cardiovascular trials and ensuring trial integrity during a global pandemic
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.
Remote management: The new normal in a post-COVID world
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.
ISO 14155: Increased emphasis on clinical data continues to trend for medical device regulations
Over the past several years, regulations for the medical device industry have continued to evolve placing more emphasis on clinical data and patient safety.
Best practices for designing digital endpoints for COVID-19 clinical trials amid uncertainty
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.
Effective patient recruitment for rare disease research
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.
Post pandemic clinical trial strategies: How COVID-19 altered clinical trials forever and what’s next
The COVID-19 pandemic forced the clinical trials industry to accept and accelerate the use of digital health technologies.
Encouraging patient participation in real world studies
Real world data offers an alternative approach to observational research, particularly to inform decisions on patient needs and preferences.
Juvenile Arthritis Awareness Month: This fight is personal
This blog is a condensed version of an ICON employee’s’ personal journey of courage and endurance.
Enabling clinical development of cell and gene therapies on a global basis
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.
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.