October 29, 2021 | THREAD expands to Europe, Middle East and Africa, TD2 adopts Medidata’s Rave CTMS, Genesis Research enhances its healthcare literature research platform, and RealTime Software improves digital signatures. Plus new products from Trialbee, Vivacare, AliveCor, and more.

Science 37 has announced two separate partnerships with key players in Japan that will help further decentralized clinical trials. First, Science 37 and CMIC HOLDINGS Co., the largest CRO in Japan, joined in partnership to further decentralized clinical trials and to help speed the development of treatments. In this collaboration, CMIC will use Science 37’s clinical trial Operating System and its end-to-end technology platform to help orchestrate workflows, generate evidence and harmonize data for global decentralized studies—helping speed study timelines. Press release. Second, Science 37 and 3H Medi Solution, a clinical trials solution leader in Japan, announced a collaboration to further decentralized clinical trials and accelerate the development of therapies. In this partnership, 3H Medi Solution will use Science 37’s clinical trial Operating System with its end-to-end technology platform for eConsent, electronic data capture, patient management, telemedicine and mobile nurse operations. Press release.

Trialbee has launched the Trialbee Honey software platform, to provide tracking and measurement of all recruitment activities, regardless of referral sources. Honey was built for patient recruitment teams to recruit and engage highly qualified patients while optimizing enrollment timelines through real-time analytics. Created to provide transparency into patient recruitment and foster convenient communication and engagement, Honey’s analytics dashboard enables study teams to consolidate participants recruited from multiple sources and increase enrollment conversions. By knowing which recruitment strategies and campaigns are bringing in the best candidates, and which sites are quick to follow up, patient recruitment teams can allocate resources to the most effective channels and sites to optimize enrollment outcomes. This includes the ability to identify recruitment strategies and channels best suited for delivering a more representative group of patients. Honey's platform is a centralized, digital infrastructure for patient recruitment in clinical trials, providing unique user experiences for patients, sites, and sponsors/CROs, all running on a common data architecture that analyzes real time recruitment and enrollment activities from all patient sources. It provides 360-degree transparency into enrollment programs, enabling adaptive patient recruitment based on real-time insights. Press release.

Solve.Care and AliveCor have partnered to enable users of AliveCor’s KardiaMobile devices and services to easily book teleconsultations with physicians on the Global Telehealth Exchange (GTHE) network. Through this partnership, physicians on the network will be able to seamlessly access users’ KardiaMobile electrocardiogram (ECG) readings, upon their consent. The KardiaMobile 6L device is the first and only six-lead personal ECG cleared by the US Food and Drug Administration (FDA). It detects more arrhythmias than any other personal ECG device. GTHE is an open global cross-border telehealth network that enables doctors and patients to connect worldwide. The partnership will see KardiaMobile devices integrated with Solve.Care’s blockchain platform to enable its users to connect with a physician on GTHE directly through the Kardia app to share their ECG readings during their teleconsultations. As physicians have access to previous ECG readings stored by KardiaMobile, this will provide physicians with a more complete understanding of the patient's symptoms to facilitate more effective ongoing care. As GTHE is built using blockchain technology, all data is fully secured and remains in control of the patient. Press Release.

THREAD has announced the company’s expansion into the Europe, Middle East and Africa (EMEA) region to support location-specific clinical trials and meet the increased demand for global studies. To support this global reach, THREAD opened an office in Dublin, Ireland in early 2021 and has hired more than 50 team members with plans to hire additional positions across Europe, including Ireland, U.K and Sweden, to amplify its regional presence. This team provides local expertise, problem-solving and change management for THREAD’s customers as their studies continue to grow on a global scale. Press release.

Translational Drug Development (TD2), a precision oncology contract research organization (CRO), has signed an agreement to adopt Medidata’s Rave CTMS (Clinical Trial Management System) and eTMF (electronic Trial Master File) solutions. Rave CTMS and eTMF are key offerings within Medidata’s Unified Platform, a platform transforming the clinical trial experience for patients, sponsors, CROs, and research sites. Press release.

Vivacare is partnering with Asthma and Allergy Network to provide a digital patient education service to their 18,000 professional members, including allergists, dermatologists, pediatricians and primary care providers. AAN members who enroll for the service receive a personalized “Patient Education Toolkit” pre-loaded with in-depth disease education resources, including printable handouts, videos, and patient support tools that can be easily distributed to patients via print, email, text or displayed on the provider’s own website. The service makes it easy for health care providers to deliver doctor-recommended health information to their patients to help them prepare for their appointments and manage their condition from home. AAN members will receive patient education resources from Allergy and Asthma Network, including a range of titles covering asthma, eczema and other allergic conditions. The patient education service also enables physicians to share their own clinical expertise with patients by publishing their own patient handouts or “Tips & Wisdom”—quick thoughts on clinical issues of importance to patients. Press release.

Veeva Systems has launched the Veeva Digital Trials Platform, a new solution to significantly advance clinical trial execution by providing a complete and connected technology ecosystem that spans patients, research sites, and trial sponsors. The Veeva Digital Trials Platform is available now for early adopters. The comprehensive product offering includes the following core solutions: Veeva Vault Clinical Suite, Veeva SiteVault Free, and MyVeeva for Patients.

The patient consent process provides a good illustration of how the Veeva Digital Trials Platform drives collaboration and data flow. Using Veeva eConsent, sponsors author and approve a consent form, which flows automatically to sites using Veeva SiteVault Free. Sites can then modify the consent form, obtain IRB approval, and consent patients with the MyVeeva mobile application. The patient status and consent form are immediately available as validated and reportable data for the sponsor in Vault Clinical Suite. Press release.

RealTime Software Solutions now offers ‘Sign on the Line’ technology integrated across all CTMS and eDOCS systems at no additional cost to customers to address concerns of clinical research site auditors and regulators. The new ‘Sign on the Line’ software feature uses similar technology as major signature companies such as DocuSign and HelloSign to place actual signature impressions throughout a document. This highly requested feature now allows clinical trial research sites, Contract Research Organizations (CROs) and trial sponsors to collect FDA Part 11 compliant electronic signatures exactly where required on a document. “Sign on the Line” technology offers a more real-world experience for users that need to sign records such as FDA Form 1572s, Financial Disclosure Forms (FDF) and binding study agreements. Current eSignatures offered within other clinical research document management systems only allow for one general eSignature on the ‘back page’ of a record to indicate a signatory’s approval or acknowledgement of an entire document. Press release.

Biotricity has announced the upcoming release of Biocare Cardiac, a personal, cardiac health application for individuals diagnosed with or at risk for cardiovascular disease. Designed to be used with Samsung's Galaxy Watch4 series, the Biocare Cardiac application continuously collects users' daily activities and provides critical information on their heart performance, empowering patients to better understand and manage their heart conditions. This new application is designed to be used as part of Biotricity's complete cardiac solution, which includes Biocare Telemed, Bioflux Diagnostics, Biokit, Bioheart, and the Galaxy Watch4 Series. Press release.

Worldwide Clinical Trials is partnering with The Christ Hospital Health Network, Cincinnati, Ohio, through Worldwide’s Site Alliance Collaboration, which will increase access to oncology clinical trials and bring new innovative cancer treatments to patients faster. The partnership builds on Worldwide’s commitment to providing the scientific, medical, and operational expertise required to meet the demands of small to midsized biotech and pharmaceutical organizations seeking to develop and successfully execute complex oncology studies. Press release.

Genesis Research has announced new enhancements to EVID AI, the world’s largest current healthcare literature research platform, that helps pharma teams and other healthcare decision makers find high quality, targeted results faster, more efficiently and from an unprecedented breadth of sources. EVID AI is the only healthcare literature database that uses machine learning to produce more than 80 million data points—from pre-clinical, clinical, economic, epidemiology, patient reported outcomes and review focus areas—and allows users to filter search results to only the most relevant, current information needed for further analysis. Researchers can quickly retrieve only what they’re looking for—outcomes, survival results, safety, efficacy, healthcare utilization, costs, epidemiology, etc.—and avoid irrelevant articles. Pharmaceutical manufacturers, payers, governments agencies, and other healthcare decisionmakers can use this platform internally or engage a Genesis Research team for additional support. Press release.