Technology platform enables vaccine trial sponsors to leverage electronic data capture benefits without compromising clinical development timelines
Philadelphia, PA – ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, today announced a technology platform that provides fast, regulatory compliant, and cost-effective clinical outcome assessment (COA) data capture during vaccine clinical development. The platform reduces the time needed to develop electronic diary cards by 75%, enabling vaccine researchers to benefit from the significant advantages electronic COA (eCOA) delivers without jeopardizing clinical development timelines.
“Vaccine researchers are under extreme pressure to meet critical development timelines ─ especially when developing seasonal treatments or responding to global pandemics,” said Tim Davis, ERT’s Vice President, Digital Patient. “Until now, the time required for electronic diary card development was prohibitive, leaving vaccine developers to rely on the traditional paper method that’s plagued with patient compliance and data quality problems and requires significant, time-intensive manual data entry and review before regulatory submission.”
ERT’s platform overcomes these challenges by pre-validating the set of standard diary card questions commonly used in vaccine trials and readying them for use across different patient groups and in multiple languages. ERT’s eCOA solution designers work with vaccine developers to incorporate their specific standards into the vaccines platform and to ensure the study design meets each trial’s specific requirements. ERT’s offering is the industry’s only technology platform that enables vaccine trial sponsors to maintain study development timelines, regardless of whether the eCOA solution is deployed on provisioned devices or via patients’ own devices (a Bring Your Own Device, or BYOD approach).
“By eliminating the need for custom eCOA solution design for every vaccine trial, we are enabling vaccine developers around the world to reap the same data quality benefits that so many other clinical trial sponsors have leveraged for years,” continued Davis. “By providing this platform, we can help researchers meet their clinical development objectives with confidence, and quickly bring much-needed vaccines to the patients who need them.”
For additional information on ERT’s vaccines platform, visit ert.com/vaccines_platform.
ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that its customers can move ahead with confidence. With more than 40 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising standards.
Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs and CROs have relied on ERT solutions in 9,500+ studies spanning three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly – and with confidence. For more information, go to ert.com or follow us on LinkedIn and Twitter.