ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, 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.”