June 25, 2020 | June was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Dynatrace, Seven Bridges, Trialbee, and more.

Dynatrace announced that ERT is using Dynatrace to automate DevOps processes, and speed up delivery of new applications, from an average of six weeks to as little as two weeks. These applications help researchers worldwide conduct clinical trials safely and effectively and bring new treatments and vaccines to market faster. They also gather data and produce reports, supplying researchers with the evidence they need to secure approval for new medical advancements from the FDA and other regulators around the world. “Our solutions are critical to our customers’ ability to get new, potentially life-saving treatments out of the laboratory and into hospitals and pharmacies,” said Simon Pilar, Director of IT Service Operations, ERT, in a press release. “Given the high-stakes nature of their business, our customers can’t afford to miss important patient data or medical alerts during clinical trials, so we have to ensure the highest levels of quality, reliability, and performance in our solutions. At the same time, we need to challenge ourselves to continually increase the speed of innovation, to help our customers accelerate their trials. By providing advanced observability across our DevOps processes and app delivery pipelines, Dynatrace allows us to see the smoke before the fire starts to burn. We can stop bad code from ever reaching production, so it never becomes a problem.” The Dynatrace AI engine, Davis, continuously monitors ERT’s DevOps processes and app delivery pipelines, watching for errors, degradations, and regressions. Davis automatically prioritizes any issues based on impact, saving developers time, and ensuring the DevOps team can find, understand, and resolve issues before they impact clinical trials. ERT also uses Keptn, Dynatrace’s open source control plane for cloud-native continuous delivery and operations. With Keptn, issues found by Davis can trigger automatic self-healing actions. This enables ERT to reduce development time while ensuring the highest standards of quality and precision. Press release

Seven Bridges announced a collaborative partnership between The Gabriella Miller Kids First Data Resource Center (Kids First DRC), ZERO Childhood Cancer (ZERO), the Children's Brain Tumor Tissue Consortium (CBTTC), the Australian BioCommons and the Australian Research Data Commons (ARDC). The multinational genomic cancer research project aims to establish internationally federated computational infrastructure that will enable the harmonization of pediatric cancer data from ZERO Australia with the extensive genomic datasets from CBTTC and Kids First DRC. Through this collaboration, researchers hope to better understand rare pediatric brain cancer subtypes and improve interventions for patients and their families. "Childhood cancer kills more children than any other disease in Australia and every week three children and adolescents in Australia die because of cancer," said Mark Cowley, Associate Professor of the Children's Cancer Institute, in a press release. "Every child is different, every cancer is unique, so treatment has to be tailored for each individual. Through an international data collaboration on pediatric cancer subtypes, we hope to better understand how to treat the cancers we find in Australia, based on information that was previously inaccessible." Research will be done on the CAVATICA Platform, a cloud-based system for collaboratively accessing, sharing and analyzing childhood cancer data. The CAVATICA Platform, powered by Seven Bridges, allows clinicians and scientists worldwide to rapidly access large amounts of genomic data and workflows within a computation and storage environment where they can share, process, integrate and analyze data. Complex and comparative analyses can be achieved using various open source R and Python packages; and through the Data Cruncher feature, data can be shared through interactive Jupyter Notebooks. Press release

Trialbee announced a partnership with Datavant to more effectively and efficiently recruit clinical trial participants. Trialbee will use Datavant’s open data ecosystem to power its innovative clinical trial recruitment and patient engagement solutions, analyzing de-identified data to determine the characteristics of patients who may be eligible and motivated to participate in a clinical trial. “We are solving for the Investigator fatigue and demotivation caused by unguided mega screening for patient recruitment and the low results it produces,” said Lollo Eriksson, chief executive officer of Trialbee, in a press release. “This partnership with Datavant will significantly expand our access to real world data (RWD) and ability to choose the information assets that are most relevant for any given trial. This unique collaboration will improve specificity and drive the right patients to clinical trials, improving efficiency and time to last patient enrolled.” Press release

Medial EarlySign announced the launch of its new Back2Care platform. With four new bundles focused on clinical domains, prioritization, and readmissions, this suite of integrated AI-powered solutions uses routine data to identify and prioritize patients who will benefit from accelerated attention. The result is actionable insights into patient and population health, allowing healthcare organizations to expedite care for high-risk patients, deliver proactive interventions, and address organizational needs in getting patients back to care. "As the healthcare community begins to emerge from the disruption caused by the coronavirus pandemic, the market is demanding solutions that help get patients 'back to care' as quickly and seamlessly as possible," said Jeremy Orr, CEO of Medial EarlySign, in a press release. "Confidence in safe visits must be restored and addressing the backlog of patients in need of screenings and ongoing care must be accelerated. The ability to leverage and deploy ML/AI to identify and prioritize patients for care is critical. As we move to the next normal, we are expanding the scope of our proven digital solutions to help healthcare organizations—and their front-line workers—successfully navigate the transition back to care." The Back2Care suite of bundled solutions enable prioritization of high-risk patients and re-engagement of populations into the clinical system. Press release

Florence Healthcare named Melinda Rodriguez, Director of Regulatory Services at Elligo Health Research, as the winner of The Florence Effect initiative. Launched in early May, The Florence Effect celebrates and brings together those who are accelerating cures through Clinical Research. Aptly named in honor of Florence Nightingale, the initiative called for nominations of inspiring clinical researcher professionals. Melinda Rodriguez was nominated as an inspiring leader for her team as they recently partnered with Verily Life Sciences to stand up drive-thru COVID-19 testing sites in California throughout March and April. Melinda courageously stepped out of her day-to-day role as Director of Regulatory Services at Elligo, to serve as a Project Manager overseeing volunteers and personal protective equipment needs, as her team worked to verify patients, swab patients and support the general triage process. Melinda worked tirelessly alongside her team, serving patients in need. “It is important for us to recognize the hard work of clinical researcher professionals, especially amid COVID-19 because they are on the front lines of discovering both coronavirus vaccines and advancing cures in other chronic disease areas,” Ryan Jones, CEO of Florence, said in a press release. “Melinda exhibits all the qualities of an inspiring clinical researcher professional. It’s important to celebrate individuals like her and honor the sacrifices they make so we can all have a better quality of life.” Press release

Crucial Data Solutions (CDS) announced today a number of enhancements to their data collection and study management platform, TrialKit. The platform’s electronic informed consent (eConsent) and electronic patient-reported outcomes (ePRO) modules were updated to optimize efficiency, enable enhanced workflows and improve the user experience for both research professionals and patients. “With the growing demand for remote data entry, information access, and management activities by site staff, study teams, and patients throughout the course of a clinical trial, the release of enhanced features for ePRO, eCOA, and eConsent activities in the TrialKit platform could not have come at a better time,” said Jeff Rogers, President of CDS, in a press release. “The impact of the COVID-19 pandemic has accelerated the need for the versatility that TrialKit offers within its web-based eClinical platform and its downloadable, native mobile app. CDS continues to lead the way with out-of-box features and innovation that meet the needs of our global client base in an ever-changing world.” TrialKit’s eConsent and ePRO modules make it easy to participate and provide data anytime, anywhere. eConsent allows trial participants to consent remotely on a smartphone or tablet. And, as part of the updated features, patients will now be prompted to provide consent before proceeding with additional data submission. Press release

The UNLV department of brain health has formally launched the Chambers-Grundy Center for Transformative Neuroscience, offering hope through scientific discovery for patients who are suffering from Alzheimer's, dementia and other brain and neurological diseases. The Center is the latest in a series of milestones from the department of brain health and the School of Integrated Health Sciences to better understand how a healthy brain functions, to improve care and treatment of people with brain diseases, and to identify mechanisms of brain disorders. The Center will drive research, track the progress of clinical trials around the world, and provide learning opportunities in the science of developing treatments for Alzheimer's, Parkinson's, and other neurodegenerative disorders. "The Chambers-Grundy Center for Transformative Neuroscience will advance the science of brain health in tangible ways to transform the lives of millions of people affected by neurodegenerative diseases today and into the future," said Ronald. T. Brown, dean of the School of Integrated Health Sciences, in an official statement. The Center will be led by UNLV research professor Dr. Jeffrey Cummings, who previously served as founding director of the Mary S. Easton Center for Alzheimer's Disease Research at UCLA and founding director of the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas. Press release

Electronic Data Capture (EDC) is no longer sufficient for today’s clinical trials, which are incorporating more virtual components and becoming more decentralized. While traditional EDC systems capture data from forms, patient data in clinical trials is now flowing at a rapid pace and at a high volume from a myriad of novel sources, such as wearables. To address this challenge, Oracle Health Sciences has introduced Clinical One Data Collection Cloud Service. With the ability to capture data from any source into a single, unified platform, Oracle Clinical One is redefining how technology supports clinical research to improve efficiency and help speed the delivery of breakthrough therapies. Oracle Clinical One Data Collection collects data from any source – forms, wearable sensors, patient apps, electronic health records (EHR), labs—and harmonizes it in a single place. This expanded data gives sites and study teams a more complete picture of the patient’s experience, and ultimately, the safety and efficacy of the investigative therapy, allowing them to make better decisions. And, because Clinical One is a unified platform, sites can randomize, dispense drug, and collect patient data in one system. Because it is easily configurable, Clinical One Data Collection meets the needs of all trial types—from the simplest Phase I and Post-Market studies to the most complex Phase III studies, across all therapeutic areas. Press release