Five Key Considerations for Writing First-in-Human Protocols Under EMA Guidelines
As pharmaceuticals move from animal to first-in-human (FIH) clinical trials, establishing appropriate strategies to minimise risk in early phase clinical trials is necessary.
What Motivates Patients to Participate in Multiple Clinical Trials?
Successful clinical trial recruitment requires a thorough understanding of the target patient profile, and a key factor within this profile is patient motivation.
FDA Acceptance of Clinical Data Collected Outside the U.S.
The US Food & Drug Administration (FDA) amended requirements for the acceptance of clinical data cllected outside the US to support medical device submissions.
Harnessing Blockchain Technology and Digital Disruption
The opportunity for blockchain in healthcare and clinical trials.
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.
Biostatistics: Using Restricted Mean Survival Time (RMST) in Oncology Trials to Improve Outcomes
Learn how to use biostatistics using RMST in Oncological trials to improve clinical outcomes
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
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.
FDA Issues Draft Guidance on Expanding Abbreviated 510(k) Program
The FDA issued a draft guidance on the Expanded Abbreviated 510(k) program, which describes an optional pathway for certain widely understood device types.
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.