Navigating CTIS: Setting up clinical trials under EU CTR
The EU CTR Nº 536/2014 came into force improving the harmonisation of clinical trials regulation throughout the EU and European Economic Area (EEA).
Digital therapeutics considerations for CNS
This blog explores DTx in CNS clinical trials: regulatory landscape, data management, endpoints, payer coverage, and future trends.
Expanding CAR T-cell Therapy into solid tumours
In this blog, learn more about a range of approaches that researchers are taking to improve the efficacy and safety of CAR T-cell therapies in solid tumours.
Keeping up to date with the latest regulatory developments for decentralised clinical trials
This blog examines the crucial topic of regulating the use of DCTs, exploring what’s in place now and what sponsors need to consider as these methods continue to gain traction.
Realising the benefits of bringing decentralised cardiovascular trials to patients
This blog reflects on the success of the first fully decentralised cardiovascular trial during the COVID-19 pandemic and highlights key elements for future trials.
Highlights from the revised Medicare Drug Price Negotiation program guidance
Explore revised guidance instructions related to the Medicare Price Negotiation program in this blog.
CMS Medicare Part D Price Negotiations
In this blog find more about a current list of drugs likely to be selected for negotiation, with their same-in-class competitors.
The new EMA guideline expectations
In this blog, discover more about the new EMA guideline on computerised systems and electronic data in clinical trials.
Patient-centric best practices for improved diversity
In this blog, we share best practices for a more patient-centric approach to trials as discussed in our webinar to improve accessibility, inclusion and diversity.
Disease surveillance in low- and middle-income countries
Disease surveillance and reporting is critical to public health, enabling faster and better response to infectious disease outbreaks.
Best practices for KPI management in FSP partnerships
Learn more about the best practices for KPI creation and management in this blog.
Disease surveillance and innovative vaccines
Learn about current approaches to disease surveillance and why they are important for the advancement of vaccine development in this blog.
EU CTR: Practical experiences and lessons learned
EU CTR effective January 31, 2022, introducing new age for interventional clinical trial applications in EU and EEA. Read more about the practical experiences and lessons learned.
Rare diseases and orphan drugs regulatory framework in Canada
This blog details initiatives that are being taken by the Government of Canada to promote a health care system that works for those with rare disorders.
The impact of the new EU Clinical Trial Regulation on language translation
On January 31st, 2023, the EU Clinical Trial Regulation and the Clinical Trial Information System went live and changed the European landscape for clinical trials.
Biotech’s evolving relationship with CROs
In this blog, read more on recent trends and learn why strategic outsourcing is a key opportunity.
Recent trends in the biotech funding environment
In this blog, discover more about how the biotech sector is transforming uncertainty into opportunity.
Improving the experience of healthy volunteers during early phase clinical trials
How ICON’s application of a volunteer-centric approach is improving recruitment and retention rates of healthy participants in early phase studies.
Pre-emptive vaccine research to improve EID response
This blog explores strategies for strengthening vaccine development so that the medical community is better prepared to respond to future epidemics.
Use of ddPCR and qPCR assays for PK and safety monitoring in Cell & Gene Therapy clinical trials
Immunotherapy technologies are rapidly advancing, as are the methods of ensuring their safety and reliability. ICON explores the tools used in CGT trials.