Early Stage Clinical Research Solutions White Papers

Managing Primary IND Applications with the FDA During the compilation of the data, it is natural to encounter results which stimulate the reader to wonder how the FDA would interpret the results and what their ensuing actions might be. In order to remove unpleasant yet preventable surprises after the filing of the IND, the FDA encourages, but does not require, pre-IND meetings where key matters can be discussed.
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How Modelling and Simulation can help in Obtaining More Information from a QT/QTc Study Over the past years, cardiac safety of non cardiovascular drugs has become a major concern in drug development. As a result, there has been an increased demand for more thorough investigations on this critical safety aspect earlier in the clinical development of a drug. Please download the free white paper below to find out more.
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Highly Automated ECG Analysis The increased scrutiny of ECG data has prompted an evolution in study execution, ECG acquisition technology and ECG data analysis over the last decade. Download the free white paper below to find out how Celerion is responding to the ever-increasing demand for automated ECG analysis.
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Creative Strategies for Quick Demonstration Interest in ‘fast-to-patient’ strategies is driven by the need to get to the clinical proof-of-concept decision as quickly as possible. It is this decision point that adds potential real value to a new drug candidate.
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SAS® Drug Development Celerion has fully integrated the SAS® Drug Development information technology platform in our Clinical Pharmacology Sciences service portfolio in order to enable more immediate client access to study data and faster regulatory submission and review of the data.
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