COVID-19 has highlighted the need for decentralized clinical trials, says Medidata as it launches a direct patient data capture technology.
Medidata has launched a decentralized clinical trials (DCT) program, which captures participant data remotely from any location at any time.
The program collects and transforms the data it receives. This enables the data to be monitored and identify any quality issues that might mitigate risk, ensuring patient safety.
“Medidata provides customers the flexibility to decentralize as much or as little as they choose, without worrying about compromising data integrity,” Anthony Costello, president, Patient Cloud at Medidata told Clinical Insider.
“The Medidata DCT Program provides the highest level of customization of decentralizing solutions based on study protocol design through a range of capabilities on a common platform that can be individually turned ‘on’ or ‘off’ in various combinations using the Trial Dial concept. This allows study sponsors to adjust and choose everything from traditional onsite trials, to fully decentralized models, and every hybrid trial design in between.”
The program is available globally and in various languages.
Pandemic push
According to the firm, the COVID-19 pandemic highlighted the need for technology to advance safe clinical trial development with many sites having to close and organizations adopting remote technology.
“The need for DCT has been made abundantly clear by the COVID-19 pandemic,” Costello told us. “DCTs lower the burden placed on participants and improve the real-time flow of data, by enabling them to engage in trial activities on their own time, despite location, and in compliance with the data requirements of the protocol.”
He added: “The virtualization of clinical trials has become the industry’s new focus because the patient, sponsor, and site benefits of decentralized clinical trials will make them a mainstay of clinical research long after the pandemic.”
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