Guide to CTIS Workspace Organization

Looking to understand the Clinical Trials Information System (CTIS) workspace organization better? Our newly released Guide to CTIS Workspace Organisation provides detailed insights into the management approaches of CTIS, including the organization-centric and trial-centric methods. The guide also offers a thorough examination of the authority workspace and its related tasks regarding clinical trial applications. This […]

Biometrics Fact Sheet

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When should you incorporate CPMS?

Clinical pharmacology modeling and simulation data is a pivotal segment of drug development, and it is common practice to incorporate CPMS later in clinical development. However, integrating CPMS earlier can bring tremendous benefits.  What role do CPMS experts play on the drug development journey?  Clinical pharmacology covers all aspects of interaction between humans and drugs, […]

5 Areas Where a Biostatistician Can Help

The FDA acknowledges the value of statisticians, involving them at every stage of the clinical trial process – and for a good reason. High-quality patient data is intrinsic to regulatory success, and must be properly managed to ensure integrity, compliance, and safety, requiring significant clinical study oversight. What role do biostatisticians play in relation to […]

A Guide to Scientific Advice

A positive outcome for your marketing authorization application (MAA) is not guaranteed. As a result, it is imperative to employ methods to maximize the potential of your MAA and set yourself up for success.    Can asking the right questions increase the chances of your trials success?  The European Medicines Agency (EMA) provides valuable scientific advice […]

A Snapshot of Gap Analysis

When building a successful regulatory strategy, it is critical to keep the end objectives in mind and design a process that is tailored to your specific product. Planning for regulatory requirements can help you avoid non-compliant practices from the very beginning, but how do you make sure your strategy is comprehensive? The answer may be […]

3 Tips for IMPD Success

The Investigational Medicinal Product Dossier or IMPD contains summaries of information related to the quality, manufacture, and control of any IMP, along with data from non-clinical and clinical studies, including the overall benefit and risk assessment.   The IMPD is a critical part of the European clinical trial application, as the clinical trial may not be […]