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Cognitive Computing Authors: Kevin Benedict, Kevin Jackson, Rajeev Kozhikkattuthodi, Yeshim Deniz, Liz McMillan

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CRF Health becomes the first to achieve Gold Standard with complete validation of Professor Juniper’s ACQ and AQLQ ePRO instruments on the TrialMax® Platform

CRF Health, the developer of the TrialMax® Suite of electronic Clinical Outcome Assessment Solutions (eCOA) for the life sciences industry, becomes the first eCOA company to complete a full validation study for Professor Juniper’s ACQ and AQLQ questionnaires to the “Gold Standard” based on her recently released “Levels of Acceptability of Electronic Versions” rating system. CRF Health continually collaborates with instrument authors to achieve the highest level of compliance with their instruments to assure data integrity.

CRF Health has now deployed spirometer integration together with the ACQ and AQLQ in several global studies on TrialMax Touch™ and TrialMax Slate™ with four major Pharmaceutical companies. Including these programs, CRF Health’s clinical reach and breadth using Professor Juniper’s instruments spans nearly 40 countries, 3000 patients, and more than 40 languages. In addition to these, CRF Health has deployed a further 15 studies using Professor Juniper’s ACQ and AQLQ instruments (but without spirometer integration).

TrialMax® solutions are available for 5 platforms including Windows, Windows Mobile, Android, Palm OS and Web, thus allowing clients to select the right platform, technology and hardware to support their clinical trials. The combination of CRF Health’s clinical expertise and innovation of ePRO collection methods, combined with patient engagement and retention tools, offer new ways to improve study execution and subject compliance.

In a recent study discussion, Professor Elizabeth Juniper commented, “I feel it is important, when evaluating a new technology device to determine whether it will give valid data, to keep in mind that validity is more likely to be achieved if the screen shots are similar to the original format especially when translating languages with longer text.”

As the most flexible eCOA solution in the industry, TrialMax offers superior usability to patients, sites and sponsors. CRF Health’s flexible, collaborative design tool, TrialStudio®, facilitates the rapid implementation of electronic Patient Reported Outcome instruments. By leveraging the TrialMax® Suite, CRF Health is clearly the leader in maintaining the integrity of instrument authors’ research and designs. In addition, the provision of world class support to patients, clinicians, sites and sponsors ensures high levels of usability and compliance.

“Professor Elizabeth Juniper’s diligence and research integrity is a model for the industry. We are excited to have had the opportunity to collaborate and to jointly achieve this industry milestone. It is through our engagement with researchers and instrument authors such as Professor Elizabeth Juniper that we continually enhance our regulatory rigor, technology competence and patient research integrity through clinical expertise and innovation,” commented Rachael Wyllie, CEO of CRF Health.

About Professor Elizabeth Juniper

Elizabeth F. Juniper, MCSP, MSc. is Professor Emeritus, Department of Clinical Epidemiology and Biostatistics, McMaster University, Canada. Professor Juniper trained as a physiotherapist and later, while at the Royal Postgraduate Medical School, took a degree in Medical Physics and Physiological Measurement. In 1973, she emigrated to McMaster University in Canada where her primary interest was in asthma and rhinitis research. Over the next decade, she was first author of classic methods papers on the measurement of airway hyperresponsiveness and she designed, conducted and published a large number of clinical trials both in asthma and rhinoconjunctivitis. Following her further degree in clinical epidemiology and biostatistics, her interest turned to the development of methods to measure subjective health status. Her asthma and rhinitis quality of life questionnaires as well as her Asthma Control Questionnaire are now used throughout the world both in research and clinical practice.

About CRF Health

CRF Health delivers electronic Clinical Outcome Assessment (eCOA) solutions for global clinical trials. The most innovative Pharmaceutical and Biotechnology companies partner with CRF Health to develop electronic Clinical Outcome Assessment strategies, transition from legacy paper instruments, and manage Clinical Outcome data to gain immediate visibility to patient assessments.

By means of our expertise and technologies we bridge the barriers to securely deliver best practice eCOA solutions for the life sciences industry, improving patient compliance, data integrity and mitigating the regulatory risks of paper based clinical outcomes assessments. eCOA solutions encompass PROs (Patient Reported Outcomes), ObsROs (Observer Reported Outcomes) and ClinROs (Clinician or Rater Reported Outcomes).

CRF Health has initiated over 400 trials in over 70 countries and 150 languages and regional dialects, including several regional Indian dialects; consistently demonstrating the industry’s highest patient compliance rates, while delivering unrivaled data accuracy and unmatched patient and site acceptance.

CRF Health, TrialMax and TrialMax Touch are trademarks of CRF Health Inc. Android is a trademark of Google Inc. Windows and Windows Mobile are both trademarks of Microsoft Corporation in the United States and other countries. Palm OS is a trademark of Palm Holdings.

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