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…
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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…
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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:…
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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.…
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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.…
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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…
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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,…
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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…
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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…
