Rare disease patients and advocates drive change in public policy
Learn how patient advocacy organisations and rare disease communities are driving change in US public policy to make safe and effective treatment options available to all patients.
The promise of glycomics in medicine
Glycomics has been a largely overlooked area of study. Nevertheless, it has the potential to have a significant impact on precision medicine and healthcare as a whole.
Battling HIV on many fronts
Discover how in-home services and a global development strategy can help us get closer to more effective treatments.
Anatomic pathology in the digital age
The development of new, innovative digital technologies has provided the tools to rethink the way we design and conduct clinical trials. One area that has been particularly impacted by this digital age is anatomical pathology.
Assessing the need for primary supporting clinical evidence or post-market clinical follow-up under MDR
Discover why identifying the study objective during the planning process for PMCF studies is a critical step in the transition to MDR.
Legacy devices under MDR/IVDR: a path forward
Regulations from 2017 set stricter requirements on manufacturers product development, data reporting, and quality assurance in place.
Health Technology Assessment: informal deal between council and European Parliament
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.
Leveraging in-home services for Parkinson’s Disease
New technologies like wearables and mobile devices, in-home services, and increased patient engagement can change the way we treat Parkinson's disease.
MDR & IVDR bottlenecks: Challenges persist despite deadlines
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.
How to improve participation of asymptomatic patients in neurodegenerative disease registries
Insight into the power of patient-registries and how they can be used to increase participation of neurodegenerative patients.
New procedures for drug prices negotiations and reimbursement in Italy
In March 2021 the Italian Medicines Agency adopted new guidelines for drug pricing and reimbursement decisions.
10 lessons learned about secondary “real world” data strategy
Insights and lessons learned about operationalizing the use of real world data.
Managed access programs as an alternative to long-term follow up studies
Managed Access Programs (MAPs), are one solution for early access to investigational products that are gaining traction.
The data revolution: Big data’s role in clinical trial patient recruitment, retention and engagement
How big data can be leveraged by pharma to solve key challenges in patient recruitment and drug development.
The role of technology in Parkinson’s treatment and research
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.
Event report - DIA Europe 2021: Advancing health priorities
Shradha Galaya, Director of Global Safety Regulatory Reporting, reports on the highlights of her recent virtual attendance at DIA Europe 2021.
Biomarker assays: Bioanalytical meets CLIA
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.
Looking back and looking ahead: Trends in HEOR
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.
Navigating complexity of cell therapy manufacturing during the COVID-19 pandemic
Over the past year, the COVID-19 pandemic significantly disrupted clinical research across the lifecycle including recruitment challenges, protocol amendments and delayed market entry.
Navigating complexity in oncology cell and gene therapy clinical trials
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