Benefits of Implementing a Unified Patient Experience in Clinical Trials
Inconsistent patient engagement has been a leading challenge in clinical trials. Learn how to overcome this challenge and maximise your trial's potential today.
A New Reality: EMA Published First Guidance on New MDR/IVDR Rules for Certain Devices
EMA recently published the first of a series of guidance documents to help applicants prepare for obligations enforced by new EU regulations on medical devices.
ADDPLAN® neo Blog Series
Read about our latest version of the ADDPLAN® Platform, ADDPLAN® neo, a fully validated, stand-alone, fixed and adaptive design simulation and analysis tool.
Regulatory Agencies Encourage Use of Adaptive Designs
Over the past few years, regulators (FDA, EMA & PMDA) have provided guidance on the use of adaptive design for clinical development. Learn more here.
An Introduction to Applications of Adaptive Design: Avoiding Unnecessary Delays, Failures
Learn how the adoption of an adaptive design strategy across the product development process brings a number of important benefits in this blog.
Adaptive MCP-Mod adds powerful dose-finding capabilities to ADDPLAN® neo
MCP-Mod can support the efficient identification of appropriate dose ranges for pivotal trials.
Convergent Development
Convergent development is key to remaining competitive in the evolving healthcare landscape
Clinical Safety Data Management - ICH E2B (R3)
In an increasingly globalised Pharmaceutical industry, harmonization is essential to assure the safety of patients.
What is the Value of Real World Evidence in Oncology in HTA Appraisals?
ICON Pricing and Market Access experts conducted an analysis to assess the value of RWE in recent HTA appraisals.
Limiting Potential Carcinogenic Risk in Drug Development with Reliable Predictions
ICON's Mgr, Nonclinical Safety Assessment, Drug Development Consulting discusses the challenges & opportunities of in silico analysis in toxicology.
An Introduction to Applications of Adaptive Design
The adoption of an adaptive design strategy across the product development process brings a number of important benefits
Lean and Mean Biosimilar Trial Design
Biosimilar clinical trials shows that strategic planning and a few simple tactics can increase return on investment and expedite time to market for biosimilars
Why you should consider using a Learning Management System
Centralising and tracking training requirements for your trials through a learning management system to make it easier for site and study staff.
Key Considerations for Achieving Digital Trial Success
Digital disruption are emerging to enable pharma and med device companies generate new datasets.
Improving Responses to Medical Device Vulnerabilities
Discover how manufacturers can improve responses to cybersecurity threats.
EMA ISO IDMP - The path forward
The EMA is implementing the standards developed by the ISO for the IDMP.
Simplifying the process of documenting Analysis Results Metadata (ARM)
Automating the process for Define –XML with ARM
Smart Bioanalytical Strategies in Immuno-Oncology Trials
Discover the latest biomarker-based methods and how they can be leveraged to add value to oncology trials.
An Introduction to Applications of Adaptive Design
Learn how the adoption of an adaptive design strategy across the product development process brings a number of important benefits.
CDISC Legacy Data Conversion
ICON’s Data Management team provides advice and guidance on legacy conversion process and what you need to implement to remain compliant.