PHILADELPHIA, Jan. 5, 2021 /PRNewswire/ -- Signant Health, the leading enabler of evidence generation for modern clinical trials, announced today that the company supported what is believed to be the fastest vaccines trial ever conducted and conditionally approved by major regulatory agencies, including the Food & Drug Administration (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA). The trial program conducted all three typical phases in less than nine months.
According to the company, the speed and accuracy of trial data collection from 40,000 patients worldwide was made possible only through electronic methodologies, including its eCOA software platform that was loaded to both provisioned smartphone devices as well as the patients' own devices (BYOD).
In total, 79% of the patient reported outcomes data were collected via BYOD while 21% of data were generated by a provisioned device.
"We believe this is an industry first in terms of overall trial speed and the quantity of patient-reported outcome data collected via BYOD for a late phase vaccines trial," said Roger Smith, Signant Health's Chief Executive Officer. "We are extremely proud to have helped our customer achieve this first-to-market advantage. The fact that the data were used to power and secure positive regulatory guidance for a Covid-19 vaccine is icing on the cake."
Smith indicated that Signant's eCOA platform was able to provide the sponsor with interim database locks every two weeks. These consistent touchpoints were critical to supporting the speed and regularity of go/no-go decisions throughout the trial.
"Trial sponsors continue to see the benefits of moving from paper-based data collection to electronic forms of data capture, particularly at a time when nearly all traditional trial approaches have been disrupted," continued Smith. "Now we have direct evidence that the data generated by patients from their own devices can effectively power a research thesis from perhaps one of the most important trials in our lifetime. And, importantly, that we can bend trial timelines while still generating high-quality data and evidence for regulatory submissions."
For more information about Signant Health, visit https://signanthealth.com/.
About Signant Health
Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently generate quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 20 years, over 400 sponsors and CROs of all sizes – including all of Top 20 pharma – have trusted Signant Health solutions for remote and site-based eCOA, eConsent, IRT, supply chain management, and data quality analytics. Learn more at www.signanthealth.com.
SOURCE Signant Health