Case Study:

How hyperCORE International and Devana Solutions Helped Rescue a Failing Study

Industry: Clinical Research
Location: USA, Canada

Formed in 2019, hyperCORE International is a vast 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 Partner members include: AGA Clinical Trials in Hialeah, FL; Aventiv Research of Columbus, OH; Benchmark Research of Austin, TX; Clinical Trials of Texas of San Antonio, TX; Clinical Site Partners of Winter Park, FL; DIEX Recherche of Sherbrooke, Canada; FOMAT Medical Research of Oxnard, CA; IACT Health of Columbus, GA; LMC Manna Research of Toronto, Canada; Moore Clinical Research in Tampa Bay, Florida and Quality Clinical Research of Omaha, NE.

What We Provided

Devana Solutions IGNITE and PROPEL Products

  • Advanced reporting, data analytics
  • Common platform to unite all companies
  • Cloud based ease-of-access, data security
  • Elite support

hyperCORE’s Results

Comprehensive Trial Data Metrics

  • Centralized communications
  • Integrated approach to trial execution
  • Site performance metrics transparency
  • Decreased study startup time
  • Increased patient enrollment

THE CHALLENGE

Communication & Efficiency

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 100 investigative sites worldwide. Recently, Dr. Kingsley received a call from a Contract Research Organization 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 clinical 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 being in the data-driven clinical trials industry, during the initial call, he immediately invited Michael Casey, Executive Director of hyperCORE International, to join the call with the CRO’s representative.

THE SOLUTION

Trial Performance Metrics Data to Align Drug Development Stakeholders

Within seconds of joining the call and informed of the CRO’s critical patient recruitment shortfall in the trial, Casey was able to generate a report analyzing clinical trial performance across the hyperCORE International global network of sites in all 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 rapidly access performance 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 immediately open them up to patient enrollment. 

Within just a few minutes, a CRO representative’s urgent outreach to Dr. Kingsley to rescue an under-enrolling trial had 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 successfully complete the study. “How was this even possible?” inquired the stunned but impressed CRO representative. The answer from Dr. Kingsley and Michael Casey was simple: Devana Solutions.

“The CRO couldn't believe it! Within seconds of introduction, 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 RESULT

Patient Enrollment Goal Achieved

hyperCORE International is now using Devana Solutions’ trial start-up workflow automation to drastically reduce the time to mobilize its top sites to complete the trial for this CRO. Devana Solutions is the leading cloud-SaaS provider of data analytics and workflow automation technology to the clinical trials industry. Research organizations representing over 3,000 Physician Investigators worldwide and rapidly growing are currently able to leverage the Devana platform to capture, analyze and display process and performance metrics for pharmaceutical Sponsors and their CROs, literally in “real time.” As a result, Devana Solutions’ innovative platform can facilitate therapeutic and operational alignment between drug development stakeholders and speed the delivery of new therapies to patients. Across the clinical trials industry, case studies continue to play out similar to this CRO’s urgent quest for sites with a proven therapeutic expertise and the hyperCORE International network’s ability to leverage the Devana Solutions’ platform and deliver the analytics to support the predictability and reliability of their sites in the specific therapy.