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International Clinical Trials

Clinical Trial Design and Build

The clinical trial landscape is changing. More methods and technologies to streamline and fast-track drug approval and commercialisation are becoming available. As such, there is growing pressure to get more studies through the pipeline faster, while continuing to ensure patient safety.

Organisations are constantly looking to identify and improve the elements of designing and building clinical trials that cause the biggest time and cost inefficiencies. One major hurdle is the methods currently being used by many organisations to collect, manage, and analyse the vast amounts of clinical trial metadata, as they don’t allow for standardisation.

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About the Author

Steven Benham has been with Formedix for over four years. Starting originally as a Solutions Consultant, he worked to author and present Formedix training courses for Standard for Exchange of Nonclinical Data, SDTM, Define-XML, ODM-XML, and Dataset- XML. He has also been involved in a number of clinical data programming projects helping to deliver in Interim Analysis SDTM and FDA SDTM clinical submissions. He is now the Professional Services Manager and currently oversees all Formedix clients.
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Avacta Announces FDA Approval of its Investigational New Drug (IND) Application for AVA6000

Cambridge and Wetherby, UK, 29 November 2021: Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms, is pleased to announce that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AVA6000. This will allow the Group to expand its Phase 1 clinical trial, ALS-6000-101, into clinical trial sites in the United States.
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