Overview
Our long-tenured team managed the eClinical component of a large oncology clinical trial with a 700+ patient population across 25+ locales. Despite the complexity of the study, we delivered high-quality eCOA solutions early, three weeks ahead of schedule.
The Organization
While our main client was an eClinical technology company, we also interfaced with the CRO conducting the study. Our ability to seamlessly manage the entire eClinical component of the study ensured the strong partnership between all stakeholders: our eClinical technology client, the CRO, and the pharmaceutical company.
The Challenge
The greatest challenge was managing the technical timeline to accommodate the needs of all stakeholders and balancing shifting study requirements. The development of this study was performed in parallel with a new core product release, which further complicated the timelines.
Additionally, this study included a BYOD (bring your own device) component, which required careful management in order to meet regulatory guidelines.
Solution
We delivered the study three weeks ahead of schedule. Because of our eClinical expertise, we know how to set and adhere to realistic timelines, prioritize deliverables, and deliver with quality. We understand the risks of complicated study builds and multiple stakeholders; we have the expertise to carefully mitigate these risks.
We were able to create and stick to a mutually agreed upon timeline. We advised our client to create a separate work stream independent of study timelines for their new feature launch. (The new feature launch was also on-time and successful.) This high-level project planning ensured an efficient use of resources and on-time delivery.
For this study, we also created an entirely new device strategy for BYOD (bring your own device) to meet budget requirements.
We take an individualized approach to each client engagement – there’s no “one size fits all” process. Instead, we create a process for each project that meets the needs of all stakeholders . We created custom, audit-ready solutions that met our client’s needs.
Finally, our long-tenured team excels at communication and has the ability to make decisions quickly, which drives efficiency throughout the eClinical development process.
The Impact
We delivered the eClinical software for a large, complex clinical trial three weeks ahead of schedule. The high quality eCOA solution benefited both clinical operations and patient experience. Overall, this project highlighted how our novel Managed Service Solution – Delivery Assurance produces high-quality software that meets clinical trial timelines.
