Explore our end-to-end, full service clinical development capabilities including Therapeutics expertise, Development Planning, Phase I early clinical development, Phase IIb/III and Phase IV Trials, Regulatory Submission and Post-Launch Studies.
In 2020, a major European sponsor launched a local country Phase I/II study. If successful, the local government needed to quickly roll out the vaccine treatment to protect its residents. Before beginning the study, the sponsor needed all data to be efficiently transferred from multiple sources and in various file types, fully validated and put into production quickly. Along with this high-volume of data input and management, the sponsor needed to set up the EDC database within the stringent timeline of 5.5 weeks, including fully validated assessments. With interim analyses scheduled for every 10 weeks during the study, all queries had to be promptly and effectively addressed to accommodate stakeholder expectations—no easy feat. Also, given the urgency, the first critical data transfer needed to occur one month after participants were given the vaccine to evaluate safety. Recognizing the need to be strategically quick and experienced in automated data management practices, the sponsor turned to IQVIA to help efficiently ramp up the trial and ensure the data environment would be able accommodate the varying study demands in a timely manner. Download the case study today
Explore our end-to-end, full service clinical development capabilities including Therapeutics expertise, Development Planning, Phase I early clinical development, Phase IIb/III and Phase IV Trials, Regulatory Submission and Post-Launch Studies.
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