EMA Publishes Second Draft Guideline on New MDR Rules Specifying Quality Requirements for Drug-Device Combinations
Key takeaways from the EMA’s second draft guidance on MDR and its impact on combination products.
Tackling RWE Challenges to Demonstrate Healthcare Value
Despite multiple challenges, RWE clearly has huge potential to inform healthcare stakeholders.
Towards a Data-Driven Feasibility Assessment
Explore how conducting a thorough data-driven feasibility assessment sets sponsors up for success in the operational aspects of their trials.
The Digitization of Clinical Drug Development
ICON expert Dr. Uma Arumugam takes a look at the advancements in digital applications and technology impacting clinical drug development.
Biosimilar Development in Ophthalmology
ICON experts Bart Chapman and Shanthi Sundaramoorthy answer common questions about ophthalmology studies, and those relating to biosimilars.
Using Economic Models to Gain Early Access
Early access schemes demand new ways of performing health economic evaluations.
How Value-Based Healthcare affects Medical Device Development
Manufacturers need to employ new methods and tools to maximise the effectiveness of their efforts in bringing new devices to market.
5 Common Barriers to Harmonised Real World Data
Learn 5 common barriers to Real World Data (RWD) harmonisation and insights on how to overcome these challenges.
ePharma IMPACT 2019 Recap
ICON's Travis Tingey attended the recent ePharma IMPACT conference and shares his thoughts on notable trends and themes.
Reflections from MAPS Conference 2019
ICON Medical Communications attended the 2019 MAPS Annual Meeting and share key themes and trends.
AMCP Annual Meeting 2019 Recap
Key topics and trends covered at the AMCP 2019 Annual Meeting.
Accelerating Drug Development for Patients with Rare Diseases
CROs can help to create more patient-centric trials placing the patients’ needs and day to day life as the highest priority in protocol and operational design.
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.