Increasingly, clinical trial sponsors are turning away from the traditional Full-Service Outsourcing (FSO) model and embracing a Functional Service Provider (FSP) model, outsourcing only those functions that they cannot perform in-house. The FSP model allows specialists to step in to lead those functions where the sponsor lacks internal resources or expertise.

Collaborating with a partner who can take the lead on the sponsor side of the technological implementation of an eCOA solution enables the clinical team to focus on other critical components of study start-up. 

Most large pharmaceutical companies employ eCOA implementation specialists who are key team members on those studies using any type of eCOA technology. This takes the burden off of the clinical project manager to oversee this important and often very complex component of a study. These implementation specialists are responsible for working with the eCOA provider to ensure that the software is being tailored to the specific needs of the study and works as intended.

Smaller companies benefit from eCOA specialists just as much – if not more – than larger companies, and eCOA Advantage fills this critical gap in the market. Clinical project managers are typically expected to be the sponsor’s key eCOA stakeholder, yet often they do not have the time or technical knowledge to serve confidently and fully in this capacity. Understanding system capabilities and limitations, reviewing technical requirements documentation, creating user acceptance testing (UAT) scripts, performing UAT, coordinating data imports, overseeing site training plans, managing translation rollouts, and more takes a great deal of time and effort. eCOA implementation on the sponsor side is often perceived to be a daunting task, and it seems that almost everyone in the industry can recount at least one story about an eCOA implementation that was fraught with issues.

However, please know this: eCOA doesn’t have to be hard! Choosing who will drive an eCOA implementation from the sponsor side is just as important as choosing the eCOA provider. In partnering with eCOA Advantage, you gain access to an expert within the eCOA niche, allowing your team a more efficient study startup. eCOA Advantage services are tailored to each client’s specific needs, with the mission being to partner with the sponsor and pursue the shared objective of study success.