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How to Source Non-IMP Supplies for Clinical Trials
When planning a clinical trial, sometimes the non-investigative medicinal product (non-IMP) supplies are given secondary thought to matters that could…
GDPR: The Implications for Clinical Development
For those based in Europe, the General Data Protection Regulation (GDPR) came into force across the European Union on May…
Industry Viewpoints: Patient Recruitment and Expanded Access
Elizabeth Williams: Can you provide an insight into the current challenges you face in clinical operations in oncology? Howard Fingert:…
Managing Blinding Requirements in IRT: An Overview
Global clinical trends show an increasing level of complexity in trial design, adding critical challenges on randomization and information blinding.…
Industry Viewpoints: Clinical Trials in Asia – Key Considerations
Mainfong Ang is a senior manager in clinical development operations and oversees studies taking place in the East and Southeast…
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Observations from GCP Sponsor Inspections
When it comes to GCP sponsor inspections there are numerous agencies throughout the world that may review your organizational practices.…
Is the GAIN Act Stimulating Antibiotic R&D?
In July 2012, the Generating Antibiotic Incentives Now (GAIN) Act was signed into law by the Obama administration as part…
Strategic Comparator Sourcing – A Matter of High Priority
Sourcing comparators can present a number of logistical and regulatory issues for clinical trial sponsors across the world. The sourcing,…
New Data Suggest HCV Remains a Problem in the US
New data from the Centers for Disease Control and Prevention (CDC)’s National Health and Nutrition Survey (NHANES) suggest that hepatitis…
How to Enable Greater Budget Forecasting
It is often said there are two types of budget forecasting, lucky and wrong. The art of true forecasting is…