Submitter
Nicholas Gambino, Director, Global Project Management, Scott Connor, Chief Marketing Officer
Company
Signant Health
Industry
Healthcare: Clinical Trials Technology
Business Challenge
The recent COVID-19 pandemic forced pharmaceutical companies such as Pfizer to develop effective vaccines in record time. To accomplish this, Pfizer needed to quickly capture accurate data for real-time analyses. Rather than risk endpoint quality by using traditional, paper-based methods, Pfizer selected Signant Health’s electronic clinical outcomes assessment (eCOA). Signant customized and implemented the digital solution to support study participants around the globe and ensure straightforward regulatory submissions.
Analytics Solution
Signant made clinical research history by implementing its eCOA solution in just five weeks, supporting more than 40,000 study participants, 17 languages and 163 sites in six countries. The eCOA solution reminded and guided participants through entry submissions to guarantee accurate completion. The responses were then stored on a central, secure server before being reviewed by regulators for Emergency Use Approval.
While the eCOA diary was deployed primarily as a bring-your-own-device (BYOD) solution, Signant delivered provisioned devices as needed. The company took necessary precautions to prevent the various BYOD screen sizes from negatively affecting the questions displayed and consequential responses. Not only did Signant’s eCOA accelerate Pfizer’s data collection, but it provided necessary safeguards, such as bi-monthly database locks. Custom push notifications alerted sites of symptoms to protect the participants’ health. As a result, Pfizer was able to make real-time analyses and informed decisions.
Impact
With the world depending on researchers to produce an effective COVID-19 vaccine, Signant enabled the Phase I, II and III studies to be completed in just nine months – the fastest vaccine trial ever conducted and conditionally approved by major regulatory agencies such as the FDA and MHRA. Signant’s digital solutions provided the detailed analytics and high-quality data needed to meet even the strictest regulations. Families and communities around the world now have access to a reliable vaccine, and Signant remains dedicated to helping Pfizer ensure safety and confidence in the immunization.