Resources and guidance for supporting employees, customers, and partners during this unprecedented health crisis.

  • November 16, 2020

Operating in a Whole New (Data Collection) World

Michele Taylor-Scott
Director, Executive Operations
This is a syndicated post, view the original post here

I recently had the opportunity to present my organization’s experiences with Clinical One Data Collection during a webinar sponsored by Oracle entitled “How to Work with Your CRO to Significantly Improve Clinical Trial Management and the Bottom Line”.

As I listened to the challenges facing emerging biopharma, it really hit home, because at Health Decisions, 70% of companies with whom we partner are facing the same issues. I truly understand the frustration that many have expressed in working with other CROs, from the lack of inclusion in selecting an Electronic Data Capture (EDC) system, to extended study build timelines (which directly impact the bottom line costs), to a lack of transparency into processes and a concern over the integrity of the data.

Throughout my career in Data Management and as the Head of Data Management at Health Decisions, I have worked with many EDC platforms. While some are better than others, in the traditional systems, there are still the major pain points surrounding CRF/System development and design, the User Acceptance Testing (UAT) process, post-production updates to the database due to Amendments...the list goes on and on. It was refreshing to know I am not alone in this sentiment, as demonstrated in the results of the webinar polling question below.

In traditional platforms, during study startup, most of us are accustomed to 10-12 week build timelines, multiple third-party data integrations, and the additional expense for separate platform modules like Coding or Local Labs. During a post-production change, there is always the concern over data integrity when migrating to a new version, as well as the time it takes to make the updates, and the downtime to sites when the new version is ready to go into production. It can truly turn into a nightmare.

With Oracle’s Clinical One, the problems that were a nightmare-in-the-making are now a thing of the past. With its sleek adaptive trial design, this truly unified platform is a great fit for Health Decisions. Using Clinical One, we have been able to reduce our study build timelines to an average of six weeks, versus the 10-12 with other platforms. With post-production changes, we can implement updates in a reduced amount of time, with no loss of data integrity and zero down time to sites. On top of that, Clinical One is truly a “one stop shop” – with built-in Randomization and Trial Supply Management (RTSM), Central Coding and Laboratory Modules. This represents time and cost savings for us, which we in turn we pass on to our sponsor partners.

This year has been a roller-coaster ride for the healthcare and clinical research industries. With COVID-19 still looming, it is key to have a platform that is flexible, adaptive, reliable, and cost effective. As an organization, Health Decisions prides itself with being on the cutting edge of technological advances that will aid us in our commitment to ensure that at every stage of life, women and girls have access to the diagnostics, therapeutic drugs, and devices necessary to manage their health and well-being. With this goal in mind, we were thrilled to partner with Oracle Health Sciences and implement Clinical One—the most advanced eClinical platform available to support complex trials in the simplest, most user-friendly way.

You can view the webinar “How to Work with Your CRO to Significantly Improve Clinical Trial Management and the Bottom Line” which showcases a demo of a database build in Clinical One and how RTSM and data collection work together in this unified platform, or you can customize your own Clinical One demo here.

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