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1 medhealthoutlook.com MAY 2022 Driving the Future of Digital Clinical Trials Innovators Medhealth Outlook 2022 CLINICAL TRIAL MANAGEMENT Cal Collins, Co-Founder and CEO Clinical Trial Management EditionHumidification, dehumidification and evaporative cooling 40-60% Relative Humidity for Infection Control To learn more about creating healthy indoor spaces visit condair.com. healthy humidity Does your medical facility’s infection control plan include humidification? Scientific studies have shown three mechanisms by which indoor humidity affects the transmission and cross infection of airborne viruses. Optimal functioning of the respiratory immune system Breathing dry air below 40%RH dries the mucous layer in our nose and throat. It becomes less effective at capturing and clearing airborne pollutants and microbes, which in turn leaves us more susceptible to infections. Reduced quantity of airborne viruses When infected people breathe, talk, cough or sneeze, they release droplets that contain potentially infectious viruses. The smaller these droplets are, the longer they remain airborne. In dry air, airborne virus concentrations have been shown to remain higher. This is due to more droplets evaporating to a size that enables them to stay airborne for longer in dry air, and greater merging together of droplets in humid air, leading to faster settling. Airborne viruses are less infectious In air above 40%RH airborne viruses suspended in droplets will more rapidly deactivate and are less infectious. In dry air below 40%RH, airborne viruses survive and remain infectious for longer periods of time. Does your medical facility’s infection control plan include humidification? Humidity for a better life3Nicholas Wilson Monica PhilipLeona George Sandy Philip Christopher MarkusAlex George James WilliamsAndrew Sebastian editor@medhealthoutlook.com Michael Robert Edward JohnDave Walker Sujay Kodoor Scott Morson Vishnu Santhosh Natasha Jacob Medhealth Outlook serves as the backdoor to the latest technologies and trends in the healthcare, pharma, and medical industries. We endeavor to be your inspiring source for print and online in-depth journalism covering the tech community powering the medical industries. Medhealth Outlook encourages readers to think extensively, lead with a mission, embrace change, and shape the fate of the business. Letters and Insights At Medhealth Outlook, we always look forward for your valuable feedbacks, comments and insights that could help us build better stories and enhance our reader’s experience. Please send your insights and comments to the editor to our office address or email. 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For permissions contact: ICON Media Inc. 30 N Gould St Ste R Sheridan, WY 82801 (646) 396 6545 Richard Taylor Jennifer LetaLowrence Tse Benny DavisSam Morris Visualizers Printing and Circulation Graphic Designers Editorial staffs Creative Team Managing Editor Editor-in-Chief Sales sam@medhealthoutlook.com sales@medhealthoutlook.com Copyright © ICON Media Inc. 2022 Subscribe @With the rising demand from end-users, the clinical trial management solutions space is experiencing tremendous growth. The pharmaceutical companies are adopting the Clinical Trial Management Systems at a faster pace to manage the clinical trials as part of pharmaceutical and biotechnology research activities. The biotechnology and pharmaceutical companies are also investing heavily in the R&D activities that encourage various companies to adopt the software tools and thereby lead to market expansion. Meanwhile, technological expansion and innovation are also adding value to these factors. Leading innovators and new businesses are adopting modern solutions including AI and machine learning to reinvent the way traditional clinical trial management solutions work. Such adaptive solutions could not only automate repetitive work but also could predict the results, to make clinical trial management a seamless process. The increasing prevalence of chronic diseases across the globe is demanding the development of an innovative drug portfolio, which in a way is boosting the market growth. Companies are also developing tools to boost the traditional performance of clinical trial management solutions and thereby fierce competition in the industry’s vital role in the market expansion. At this juncture, to help businesses dive deeper into the clinical trial solutions space and help align with the trends, we are publishing this special edition on Clinical Trial Management Solution Providers. We’ve also included insights from some of the leading CEOs, business experts, and industry veterans. We hope this edition adds value to your clinical trial initiatives. Voice of the Editor Natasha Jacob Editor-in-Chief A STEADY GROWTH GRAPH AT EVERY STAGE!The Premier Clinical and Regulatory Resource Streamlining Research Operations YPrime: The Future of Clinical Research PROXIMA CRO REALTIME YPRIME Kevin Coker, Co-founder & CEO Rick Greenfield, CEO Shawn Blackburn, CEO 16 22 26 Driving the Future of Digital Clinical Trials Innovators Medhealth Outlook 2022 CLINICAL TRIAL MANAGEMENT Cal Collins, Co-Founder and CEOContents WHEN IS YOUR PHONE A MEDICAL DEVICE: REGULATORY ISSUES IN HEALTH DIGITAL TECHNOLOGIES MACHINE LEARNING – FUTURE OF HUMAN COGITATION HOW UTILIZING REMOTE PATIENT MONITORING FOR DECENTRALIZED CLINICAL TRIALS CAN ENHANCE COMPLIANCE AND PREVENT DATA LOSS Jackie Mulryne, International Partner, Arnold & Porter Dr. Raul V. Rodriguez Pro Vice-Chancellor and Pokala Pranay Kumar Research and Teaching Assistant, Woxsen University Andy Maloy, senior vice president of technology and clinical trials, Verustat 28 36 24 18 32 THE FUTURE OF CLINICAL TRIALS IS DECENTRALIZED. AND BETTER, FASTER, CHEAPER. Joseph Wood, MD, PhD, VP, Decentralized Trials and Virtual Health, Equideum Health AI/ML IN LIFE SCIENCE COMPANIES – CALL TO ACTION THE NEED AND USE CASE Velayutham Gomatinayagam, Vice President, Client Delivery Management, NTT DATA Services MED NSIGHTS8 I t’s no surprise that the future of clinical trials is becoming more digital and decentralized. Traditional approaches are being replaced with ones that enable more automation, less burden on site staff, and integrations (such as EHR eSource data) that help researchers collect better data, faster. Covid-19 accelerated this need for better tools and solutions due to the necessity of quickly collecting and analyzing data on the virus so that there were less illnesses and deaths. Facilitating these and other unique clinical trial requirements with innovative solutions is OpenClinica, a company that is driving the future of digital clinical trials. OpenClinica has been transforming clinical research with its unified, core electronic data capture (EDC) platform that simplifies the process of running clinical trials in the cloud. “At OpenClinica, we offer a platform with an intuitive user experience as well as dynamically configurable logic for workflows and integration. This way, clinical trial management becomes seamless,” begins Cal Collins, Co-Founder and CEO at OpenClinica. OpenClinica is used across a wide spectrum of clinical research, including drug, device, and diagnostic trials, global health studies involving over 2 million Driving the Future of Digital Clinical Trials Innovators Medhealth Outlook 2022 CLINICAL TRIAL MANAGEMENT COVER STORY9 Cal Collins, Co-Founder and CEO At OpenClinica, we offer a platform with intuitive user experiences as well as a dynamically configurable logic for workflows and integration to eliminate duplication of data entry. This way clinical trial management becomes seamless.Next >