Blog

Regulations from 2017 set stricter requirements on manufacturers product development, data reporting, and quality assurance in place.

In June 2021, representatives of the European Parliament and the Council of European Union reached an agreement to boost cooperation amongst EU member States on HTA.

New technologies like wearables and mobile devices, in-home services, and increased patient engagement can change the way we treat Parkinson's disease.

The new In Vitro Diagnostics Regulation (IVDR) and Medical Device Regulation (MDR) provide regulatory frameworks and conformity assessments that promote medical device safety and efficacy.

Insight into the power of patient-registries and how they can be used to increase participation of neurodegenerative patients.

In March 2021 the Italian Medicines Agency adopted new guidelines for drug pricing and reimbursement decisions.

Insights and lessons learned about operationalizing the use of real world data.

Managed Access Programs (MAPs), are one solution for early access to investigational products that are gaining traction.

How big data can be leveraged by pharma to solve key challenges in patient recruitment and drug development.

Constant study and innovation of Parkinson's Disease (PD) research has shown the implementation of medical devices, AI, and mobile applications pave the way forward.

Shradha Galaya, Director of Global Safety Regulatory Reporting, reports on the highlights of her recent virtual attendance at DIA Europe 2021.

The blog considers current perspectives on the use of biomarkers, differences between the needs of biomarker assays developed for use in bioanalytical labs or clinical labs, and what may be needed in the case that a biomarker assay needs to migrate into a CLIA lab.

In-person research became impossible due to the pandemic, and forced us to re-examine how patient's voices were being captured. In 2021 we continue to build on what we learned.

Over the past year, the COVID-19 pandemic significantly disrupted clinical research across the lifecycle including recruitment challenges, protocol amendments and delayed market entry.

As more knowledge is revealed about the genetic underpinnings of cancers, cell and gene therapies (CGT) are playing an increasingly important role in treating oncology patients

Improved diagnostic technologies, prevention methods and the advent of targeted therapeutic approaches have together contributed to lowering the mortality rate for the 10 most prevalent cancers

The success of cell and gene therapies (CGT) has transformed the delivery of clinical trial services, requiring the design of new workflows, processes and tools.

Advances in our understanding of cancer biology and the tumour microenvironment (TME), have led to the development of personalised drug and therapy designs to better prevent disease progression and relapse.

In a statement on February 2021, the UK’s National Institute for Health and Care Excellence (NICE) launched a public consultation on proposals for changes to the processes it uses to develop its guidance on medicines, medical devices, diagnostics and digital health technologies.

ICON's Hayley Christensen shares her personal experience with Cystic Fibrosis.