Sharing my rare disease story - Hayley Christensen
ICON's Hayley Christensen shares her personal experience with Cystic Fibrosis.
Sharing my rare disease story - Tamie Joeckel
ICON's Tamie Joeckel shares her personal experience with Type 3 Hereditary Angioedema.
Sharing my rare disease story - Amanda Huber
ICON's Amanda Huber shares her personal experience with Alpha-1 Antitrypsin Deficiency (Alpha-1).
Sharing my rare disease story - Julia Tonge
ICON's Julia Tonge shares her personal experience with Amniotic Band Syndrome (ABS).
mRNA vaccines from COVID-19 to HIV
How one virus accelerated vaccine research, spurring innovation and hope for a cure in another
Executing under pressure: Developing a strategy for high risk devices under IVDR
Manufacturers who have not begun preparations will need to adopt a strategy to address gaps in meeting the new regulation.
The Importance of partnering for bioanalytical studies
Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.
Clinical Evidence under IVDR - how much is enough?
The new In Vitro Diagnostic Regulation (IVDR) aims to harmonise regulatory framework across the European Union (EU) to ensure the safety and performance of devices by placing greater responsibility on manufacturers to demonstrate that their products meet stringent requirements.
Data capture: The benefits and evolution of eCOA
As the demand for improving patient safety in clinical trials continues to rise, so will the use of technology as a way to better capture data and enhance clinical outcome assessments (COAs).
Risk, vigilance, and remediation under IVDR
The In Vitro Diagnostics Regulation (IVDR) — which goes into effect on May 26, 2022 — will have a lasting impact on the entire in vitro diagnostics (IVD) lifecycle, from development through clinical investigations and regulatory approval.
Managing COVID disruptions within IVDR timelines
The COVID-19 pandemic has greatly impacted the IVD industry, including travel and social distancing restrictions, creating hassles and stalling NB designation processes.
Exploring the benefits of biotech partnerships
The biotechnology sector is leading the way in developing innovative therapies that will address the unmet needs of many challenging diseases.
Cancer research post-COVID-19
The COVID-19 pandemic has been a catalyst for change in cancer research, forcing a shift towards remote monitoring, virtual arms and other uses of digital tools as global lockdowns reduce the ability of patients to go to clinics.
Harnessing digital health to advance traumatic brain injury clinical trials
Advances in wearable technology have provided an effective tool to monitor outcomes and facilitate the delivery of interventions in patients across indications, especially those in need of rehabilitation interventions.
Bringing an invisible battle to the forefront: How to better design military-related TBI clinical trials
A form of acquired brain injury that occurs when trauma causes damage to the brain, TBI has become increasingly apparent in military personnel.
C diff and COVID-19, is this a health risk that can be dealt with sooner than later?
Today, with the development, widespread use, and poor prescribing practices of antibiotics over time, C diff infection rates have increased exponentially.
Agile clinical monitoring: the flexibility to adapt to study dynamics
The use of a well-executed hybrid monitoring strategy is the way forward for companies to remain agile adapting to therapeutic, regional and patient considerations.
Dirty data: How to manage data from wearables in clinical trials
How to manage data from wearables in clinical trials — from overcoming regulatory issues to handling challenges associated with dirty data.
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.