We recently wrapped on our 3rd annual Zelta User Conference. We had a fantastic two days in Chicago, packed with insightful panel discussions, tantalizing previews of our product roadmap for 2025 and beyond, and most importantly, some inspiring success stories of how Zelta users are leveraging the platform to transform their clinical trials and drive bold research. If you couldn’t make it this year, here are three of those user success stories you missed.
An innovative, global medical device company that champions solutions for women’s health, Hologic has used Zelta EDC since 2014 to run a variety of clinical studies. For years, Hologic has struggled with repeating page concerns. Because they could not use repeating rows in their studies, they would try to get around this by using repeating pages in the CRF design to load the data into the EDC system, using the API/Migrator.
Mona Rayala, senior clinical data analyst at Hologic, spoke at this year’s Zelta User Conference to share how this has created headaches for reviewing and verifying data.
All of these steps added more time, more work, and more complexity into running and verifying clinical studies. Zelta heard this concern and, in order to help Hologic to enable their studies and users to become more efficient and more nimble, rolled out a new design structure. Thanks to this new feature, Hologic studies can now create separate sections within the CRF, with a new capability for adding dynamic repeating rows. This feature allows the Zelta API/Data Migrator to add the number of rows needed for a run into the CRF automatically – something that Hologic hailed as a game changer for their studies.
With separate sections for Run and Tube info located on a single page, the study Monitor can review, verify, and set page statuses without additional navigation – or additional training required for other users. All of which makes it faster, simpler, and more intuitive to build and run studies.
“Zelta’s new capabilities have been great assets that Hologic will leverage for future studies. They simplify the process of loading assay data by transitioning from repeating pages to a more efficient single page layout with automatic repeating rows. This streamlines the data clinical monitor and clinical site review process. As a data manager, anything that makes my EDC’s user life easier makes my life easier.”
--Mona Rayala, Senior Clinical Data Analyst, Hologic Inc.
A healthcare research and data company that uses Zelta mains their own proprietary database of trial participants, which they draw from for designing studies around health economics and outcomes, safety and epidemiology, clinical research, and patient-centered research. Maintaining this database requires ingesting data from multiple sources and making decisions about, why, and how to best integrate it together. Historically, that process for data collection was made using a single-decision point approach to study design.
The problem? As the company’s senior director of data management pointed out: this approach treats data managers like an afterthought. The study protocol is developed, stakeholders are engaged for their input, and the protocol is then handed off to the data managers to begin collecting data. But this company's clinical data managers have long evolved their roles into clinical data scientists – and data scientists, in order to truly apply innovative approaches to trial design, need to have a seat at the table at all stages of the study’s lifecycle and provide input on the data being collected. This required rethinking their approach, building a multi-point decision process that could more nimbly react to treatment protocols, platform innovations, and study updates.
“One size fits all no longer workers in a multiple data source model. Disparate data sources can increase variety, efficiency, and accuracy of data, but also complicate quality, integration, and analytic efforts.”
--Senior Director of Data Management
The flexibility of the Zelta EDC platform allowed Carelon to do just this: build a multi-point decision model that would put the data managers in the driver’s seat for study design and innovation, creating a data journey map to identify the what/when/how of the data being collected, and make more informed decisions about how you build studies for users.
“We’re thinking about it by data point. Something that works for an EDC data point may not work as well as something you grab from a registry. Zelta helps us enable a multi-point decision-making model where our data managers are in control and can make the best decisions for the lifecycle of the study.”
--Senior Director of Data Management
This approach provides a better understanding of what any given team’s system and staffing capabilities are, helping to reduce burdens on sites and patients and benefit both standard and decentralized clinical trials.
Alimentiv first partnered with Zelta in 2012, and over the course of our 13 years together, Alimentiv has successfully launched over 250 databases on the platform – 20 of which have used the Zelta ePRO module, collecting over 193,000 patient-reported outcomes in all.
But as Chris Walker, Alimentiv’s Senior Director of Clinical Data Sciences, shared, successful ePRO implementations across the industry have been hindered by a number of challenges, including:
At the same time, the role of the Clinical Data Manager is undergoing a transformation. CDMs are developing deeper expertise in CRF design, regulatory requirements, and system configuration – skills that position them perfectly to take on greater ownership of ePRO development. Alimentiv discovered that interlacing Clinical Data Management into ePRO development processes could help them provide more operational efficiencies and enhance the quality of patient-reported outcomes that are so closely related to study endpoints. In other words, having their CDMs run the ePRO configuration for certain trials.
The ePRO module built in Zelta’s unified EDC platform allowed Alimentiv’s study team to do just this. Zelta ePRO ensures patient-reported data is captured directly into the EDC system, enabling real-time review, seamless reconciliation, and greater operational efficiencies that save time and costs.
As the scope of CDM continues to expand, these professionals are now uniquely positioned to lead ePRO/eCOA delivery from within the EDC environment. Zelta’s integrated platform allows them to manage the full lifecycle of patient and site-reported data – making timely, data-driven assessments with greater efficiency, accuracy, and control than ever before.
“EDC-embedded ePRO is an incredibly valuable tool we’ve added to Alimentiv’s toolbox. It allows us to have data readily available. In our therapeutic area, we’re highly reliant on patient-reported data to support endpoints. With Zelta, there’s no sync, no lag, the data is already committed directly to the EDC, and that helps us be one step quicker to a decision.”
--Chris Walker, Senior Director of Clinical Data Sciences, Alimentiv
As a bonus, here are a few more testimonials that Zelta users shared at this year’s user conference about their experience with the platform and how they’ve used it to transform their clinical trials and make their lives easier.
“I exclusively use Zelta for the last 12+ years for building studies and managing clinical studies. I reach out to the Zelta team for any hiccups that I face. They respond within a couple of hours and the solution they give is spot on. I really appreciate their support.”
Natesan Elango, Fellow, Clinical Affair/Medical Affairs, Endologix
“We love Zelta, we’ve been using it for 12-13 years, it’s our baby. I have over 8,000 study connections, 60,000-page modifications, and we are looking forward to v2 solving some of the existential problems we had with v1. The Zelta User conference has gone a long way in reassuring me that v2 is the future.”
Peter Hmel, Director of Data Management, Fast-Track Drugs & Biologics, LLC
“The first thing I think of when I think of Zelta is it’s user friendly. Easy to use, easy to build.”
Katrina Riggs, CEO, Fast-Track Drugs & Biologics, LLC
“Zelta User Conference 2025 was jam-packed with value, interesting insights, and great knowledge sharing.”
Anonymous
“I continue to be impressed by Zelta team’s dedication to enhancing the system. They obviously care about what their clients need and always deliver high quality results.”
Anonymous