Outsourcing-Pharma (OSP) recently chatted with Mark Maietta (MM), president of YPrime, about the evolution of data collection and use in clinical research, the features of its latest electronic clinical outcome assessment (eCOA platform), and how companies are keeping up with the various demands and pressures.
OSP: Since your firm began 15 years ago, the clinical-trial data tech landscape has changed. Could you please share: how the capabilities of the tech and demands placed upon it has evolved?
MM: Technology is in a constant state of evolution and companies must be careful not to adopt everything that is out there. We have taken a very methodical approach to reviewing new trends and tools that are available against what our industry is asking for; this means that we pass on a lot of things that we look at, but implement the ones that can have a positive impact on the things we do.
Our success has come from the ability to take advantage of the agility that the cloud provides to us. Our platform has grown due to the simple fact that the cloud allows us to ensure that we can scale to meet our ever growing industry while still keeping the security that is required to protect the important data that we collect.
OSP: How has the tech your company evolved?
MM: This is a forward-thinking, problem-solving company. We welcome the challenges that we face every day and push ourselves to find new, innovative ways to solve these challenges; this mindset has forced us to evolve along with the industry and technology landscape.
Over the past five years we have tailored our software platforms to be flexible enough to adopt new technologies and approaches as they become available. As a whole, our company has transitioned from a traditional waterfall software development company to a very agile development group that can quickly pivot to fill any need that may present itself. This, coupled with the adoption of test automation, means we are now able to quickly rise to any challenge while still delivering the level of quality that we demand.
OSP: Can you talk about the updates in this latest iteration of your eCOA platform? How do these new features/capabilities meet the demands of clinical trial pros?
MM: With the pandemic having a serious impact on the way our industry does business, it was important for us to ensure our platform could keep up. Our 5th Gen release does just that. We have included a unique new approach to BYOD, supporting rapid deployments and remote patient enrollment. This release also speeds the time of delivery by enhancing the configuration control we have over the system, allowing us to quickly configure and deliver a high quality, easy to use platform.
OSP: Could you please share a little more detailed explanation of how this 5thGen version increases the patient-centricity of your solution?
MM: Patient-centricity really boils down to how easy a platform is for a patient to use. We have focused on reducing the burden placed on patients from enrollment through data entry by expanding the options that are available to them. Our 5th Gen platform not only enables remote enrollment and participation but troubleshooting and support as well.
OSP: Why is patient experience/engagement important to consider for eClinical solutions in general?
MM: Whether it is eClinical solutions or specifically eCOA, the patient’s experience and/or engagement means everything. A happy patient means a happy site which translates to a happy sponsor. Without the patient we don’t have clinical research — we don’t have an industry — so we owe it to them to reduce any burden they may have when entering into a clinical trial.
As an industry we need to make the experiences easy for them; their lives are already busy and complex. If we do that, then we can focus on keeping them in the trial, on engagement. It’s hard to get patients and once you have them, you need to make sure you keep them. We owe patients the best experience possible.
OSP: Why is patient experience/engagement important to consider for eCOA tech specifically?
MM: Historically, the eCOA industry has caused a lot of difficulties and that is the main reason we at YPrime decided to develop our eCOA platform. We built a platform specifically to minimize or eliminate the issues which have traditionally caused a lot of burden on the patient, site, and sponsor.
eCOA can take up a lot of time for a patient and although it is much easier to use than paper, there is still a burden patients feel. It is imperative for eCOA to be intuitive and reliable to ensure patients have a good experience and stay engaged.
OSP: Could you elaborate what you mean by “cleaner data” and how this benefits the site team, sponsor, patients and other stakeholders?
MM: The end result of all of the work that is put into these trials is the data that is submitted for drug approval, and the data captured from sites and patients is the most important piece of that. We pride ourselves on the quality of the data that we capture.
Ensuring our data adheres to strict industry standards during the configuration phase allows us to deliver a submission-ready package quickly, with little or no manual intervention after the data has been entered. This provides the speed and peace of mind that sponsors need when preparing their final submission package.
OSP: Can you share any ways in which your technology, now and/or prior to the upgrades, is positioned to help users deal with the challenges created/exacerbated by the COVID-19 pandemic?
MM: Here is the big issue COVID-19 caused in the eCOA space: When a patient is supposed to fill out their reported outcomes at the site and now they do not want to go to the site or the site has had to restrict access, how can the patient provide that very important data?
YPrime created a web backup solution in three weeks to ensure important data gets collected while reducing the burden of the patient having to go to the site during these difficult times.
OSP: Do you have anything you’d like to add—either about this platform, or your company overall?
MM: We continue to challenge ourselves to create the best eCOA solution in the industry. A platform that is reliable, easy for patients and sites to use, that ensures any burden we can impact is dramatically reduced or eliminated.