How RealTime-Devana and hyperCORE International Helped Rescue a Failing Study

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BEFORE

hyperCORE International Before RealTime

AFTER

hyperCORE International After RealTime

Overview

Formed in 2019, hyperCORE International is a super network of highly experienced and awarded clinical research site/network companies. Its member companies have over 100 years of combined experience and have completed more than 6,000 studies helping to evaluate thousands of new drugs and treatments in more than 15,000,000 patients.

hyperCORE Alliance Partner members include AGA Clinical Trials, Alcanza Clinical Research, Apex Trials, Applied Research Center of Arkansas, Avacare Clinical Research Network, FOMAT Medical Research, Quality Clinical Research, and TrueBlue Clinical Research.

The Challenge

Dr. Jeff Kingsley is CEO of IACT Health, a 14-site research network based in Columbus, Georgia. IACT Health is also a founding partner in hyperCORE International, a “super network” of clinical research organizations with over 90 investigative sites worldwide. Recently, Dr. Kingsley received a call from a Contract Research Organization (CRO) based in Southeast Asia. The CRO was managing an Atopic Dermatitis clinical trial in which patient-recruitment by the sites originally selected to complete the study had stagnated while still 30 patients short of the required number of subjects.

The CRO’s representative earnestly pressed Dr. Kingsley: “Did IACT Health and the hyperCORE International network of sites have experience in Atopic Dermatitis? Might the network be able to mobilize quickly to recruit, screen, and enroll the remaining 30 subjects so the trial could proceed, confident in having sufficient patients to yield the data required to determine whether the therapy was safe and effective?”

Dr. Kingsley was able to speak to his own investigative experience with Atopic Dermatitis, but in the data-driven clinical trials industry, he immediately introduced the CRO’s representative to Michael Casey, Executive Director of hyperCORE International.

The Solution

Using RealTime-Devana, previously PROPEL, Mr. Casey was able to generate a report analyzing clinical trial performance across the hyperCORE International global network of sites in dermatological studies and, specifically, Atopic Dermatitis. The site performance metrics included the total number of completed trials, completed patients, contracted total patients, contract met percentage, screen failure rates, early termination percentages, and a host of additional data. Being so impressed with hyperCORE’s ability to access metrics to validate the individual site capabilities, the CRO’s representative simply greenlighted Mr. Casey to go ahead and select the specific hyperCORE sites on the CRO’s behalf and they would open them up for enrollment.

Within just a few minutes, a CRO representative’s urgent outreach to Dr. Kingsley to rescue an under-enrolling trial had quickly pivoted to the CRO’s receipt of a trove of site performance data demonstrating the hyperCORE International site network’s ability to help screen and enroll the remaining patients required to complete the study.

“How was this even possible?” inquired the CRO’s representative. The answer from Dr. Kingsley and Mr. Casey was simple: Devana.

“The CRO couldn’t believe it! Within seconds, they were holding reports and dashboards validating the predictability and reliability of our sites in the indication!”

Jeff Kingsley, Chair, COO & Founding Member
hyperCORE International

The Results

Across the clinical trials industry, cases continue to play out similar to this CRO’s urgent search for sites with proven therapeutic expertise. hyperCORE International’s ability to leverage Devana and deliver analytics to support the predictability and reliability of their sites in the specific therapy set them apart and won them the opportunity. hyperCORE International also used Devana’s trial start-up workflow automation to drastically reduce the time to mobilize its top sites to complete the trial for the CRO.

By automating the process of capturing, analyzing, and displaying process and performance metrics in real time for pharmaceutical sponsors and CROs, the Devana platform helps facilitate therapeutic and operational alignment between drug development stakeholders, speeding the delivery of new therapies to patients.

With RealTime-Devana, hyperCORE International was able to capture, analyze, and display real-time site performance metrics, helping secure a high-priority trial. Other benefits include:

  • Real-time performance metrics and reporting
  • Common platform for central and site-based teams
  • Exponential growth and scalability become a reality
  • Single source of truth
  • Centralized communications and trial management

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