Situation
Vaccine studies typically involve large patient populations and generate a wealth of data. The traditional approach to collecting this data is by using paper diary cards. However, the need for manual data entry adds significant back-end costs and can delay the analysis of results. Electronic data capture offers advantages in terms of timely collection and processing, improved data quality, and an enhanced patient experience.
A top 10 pharma company with a large vaccines pipeline sought to capitalize on the benefits of electronic data capture by implementing a standardized and scalable digital solution for their vaccine studies. However, they needed to minimize the risk of transitioning to a new patient data capture approach.
“Ensuring a smooth transition can be a concern for pharmaceutical companies looking to move to electronic data capture,” says Terry Burke, EVP eCOA, Clario. “Using a flexible approach, we sought to deliver a scalable platform that met the needs of both the client and patients.”
Ensuring a smooth transition can be a concern for pharmaceutical companies looking to move to electronic data capture.
Terry Burke
EVP eCOA, Clario
Solution
Clario proposed a staged approach to streamline moving from paper-based diary cards to electronic data capture. The Clario Vaccines solution was implemented in a real clinical study as an initial pilot program. Using a configurable eCOA platform meant that the study could be delivered quickly and easily whilst accommodating the needs of patients, site staff and stakeholders. The staged roll-out strategy sought to deliver a Vaccine template that could be implemented across the customer’s pipeline and enable economies of scale at minimum risk.
Impact
The Clario Vaccines solution allowed the pilot study to be implemented in an accelerated timeframe of just 10 weeks, compared to typical timespans of 12–16 weeks for traditional electronic clinical outcome assessment (eCOA) delivery. Provisioned devices were used to streamline roll-out, supported by a comprehensive site and patient training package. The solution’s flexible architecture enabled full integration with the client’s existing EDC system and included a range of easy-to-use patient management tools and alerts. User-friendly features such as the site portal simplified patient enrollment and alerted site staff to missed data entries, while configurable reporting tools provided stakeholders with powerful insight into study data.
Erroneous and missing data entries were minimized, and processing time was significantly shortened. The number of helpdesk tickets received within the first two months was greatly reduced. Moreover, the system enabled access to real-time information and provided streamlined data analysis for regulatory submission. The staged approach offers a cost-effective, risk-reduced solution to introducing electronic data capture into the client’s vaccine pipeline. Following this successful pilot study, the next stage was to expand the capabilities of the client’s Vaccine template.