The Future of Automation and Digital Transformation in Late Phase Research
Late phase studies are ripe for digitalisation, although not always in the same ways as Phase II and III programs.
NASH Clearing Clinical Trial Hurdles in Race to $35 billion Market
NASH ranks among the world’s great emerging health threats
Controlling Logistics Costs Can Significantly Reduce Trial Lab Expenses
ICON has developed a lab logistics program to reduce costs
Making the Move to Virtual Clinical Trials
Late phase research, once the exception, is becoming the rule. Some post marketing evidence needs can be met with virtual studies, DtP and cyber studies.
Data-driven Site Selection Aids Accelerated Study Start-Up
There is an increasing demand from sponsors for technology and data-driven solutions to improve site selection, study start- up and patient recruitment.
Smart Ways to Collect Real-World Data for Device Trials
An insulin injector is significantly safer and easier to use, and therefore leads to fewer complications and better clinical outcomes.
Scientific Publications: Best Practices in Publication Planning
This is the first posting in a three-part series drawn from ICON’s webinar, “Evolving Best Practices for Working with Authors—Authorship and Beyond.”
Regenerative Medicine Advanced Therapy Designation - Supporting Expedition in Drug Development
Find out about the FDA's pathway to assist industry in expediting drug development.
mHealth Devices Allow for Better Treatments and Clinical Outcomes
Benefits include better, more personalised, treatment and improved clinical outcomes, with fewer clinic visits and greater independence for patients.
How Patients and Developers Benefit in a Digital Health Ecosystem
Emerging mHealth technologies are transforming patient care by integrating health data across the healthcare landscape.
Scaling Up CAR-T Therapies Requires Overcoming Manufacturing, Regulatory and Distribution Challenges
Recent approvals of CAR-T immuno-oncology therapies present a market opportunity estimated to grow nearly 50 percent annually over the next decade.
Is your Drug Master File (DMF) Ready for May 2018?
Drug Master File electronic submissions to the FDA deadline is fast approaching.
FDA Commends the Signing of the FDA Reauthorization Act of 2017
The FDA announced a proposed programme for publishing certain device malfunction medical device reports.
The Power of AI to Transform Clinical Trials
Artificial intelligence (AI) technology, combined with big data, hold the potential to solve many key clinical trial challenges.
Patient-First Rapid Site Activation Accelerates Timelines
Patient-First Rapid Site Activation can greatly reduce the time and cost spent on non-performing sites by never activating them in the first place.
Scientific Publications Technology Solutions
This is the third article in a three-part series from ICON’s webinar, “Evolving Best Practices for Working with Authors—Authorship and Beyond.”
The Impact of Brexit on UK Economic Operators and Notified Bodies
The European Commission issued a Notice to Stakeholders entitled, “Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products.
FDA Voluntary Malfunction Summary Reporting Program for Manufacturers
The FDA announced a proposed programme for publishing certain device malfunction MDRs.
Leveraging Voice-Assistant Technology in Clinical Trials
Voice Assistant technologies provide an opportunity to create a different level of engagement and interaction in comparison to regular apps and web pages.
Not If, But When: Five Cybersecurity Threats You Can Expect
Assess how well equipped you are to meet today’s cybersecurity needs.