November 10, 2020 | New products, collaborations and deployments from the past two months from Medable, Thermo Fisher, Seqster, Takeda, Medidata, Caris Life Sciences, Oracle, Lyft, Elsevier, and more.

The U.S. Department of Veterans Affairs’ (VA) Office of Research and Development (ORD) is successfully implementing WCG’s IRBNet electronic submission and review system for more than 100 VA medical centers (VAMCs) that have research programs. In 2019, the VA selected IRBNet over other available solutions as the best solution to meet its complex research and compliance needs on an enterprise scale and to standardize processes among all sites. IRBNet provides technology-supported workflow, communication and documentation capabilities, assisting IRB compliance with ethical and regulatory standards for the inclusion of appropriate human subject protections, and the oversight of study conduct as mandated by federal guidelines. Press release.

Medable has announced Medable TeleCOA. This new offering combines electronic Clinical Outcome Assessments (eCOAs) with TeleVisits on web and mobile to enable critical study outcomes to be captured from the comfort of a patient’s home, anywhere in the world. This industry-first combination will facilitate the transition of eCOAs from clinic-only to remote and decentralized settings, improving patient access and engagement. The platform enables study-specific digital workflows for patients and sites for recruitment, screening, consent, and throughout study conduct. Medable TeleCOA allows outcome assessments to be conducted remotely via web and mobile, within a unified digital experience across the entire study workflow. Press release.

Innovation Sprint, a Belgian digital biotech company, is partnering with Fondazione Policlinico Universitario “Agostino Gemelli” IRCCS in Rome, Italy, to co-sponsor the clinical trial “APACHE: Advanced patient monitoring and A.I. supported outcomes assessment in cervical cancer using Internet of things technologies”, involving both the Gemelli advanced radiotherapy center and the gynecology department. The primary objective of this 24-month trial is to evaluate whether monitoring oncological patients during multimodal cancer therapies may represent a significant step towards a comprehensive and reliable quality of life assessment, prevention of toxicity before its clinical onset, and treatment outcomes prediction. Innovation Sprint has deployed its eClinical solution Healthentia in APACHE, to enable a seamless ePRO/eCOA collection of reported outcomes and assessment of physical activity, emotional and lifestyle status of patients undergoing cancer therapy. Press release. 

Thermo Fisher Scientific has expanded its Direct-to-Patient services to now include Clinical Site-to-Patient, Pharmacy-to-Patient and Depot-to-Patient services to enable clinical trial medication delivery directly to patients' homes. The program can support any trial phase and a range of trial variables including Interactive Response Technology (IRT) systems, blinded/unblinded and home nursing providers. Clinical Site-to-Patient services are available in 47 countries and have supported more than 1,500 shipments to patients worldwide to help treat more than 25 different indications. Press release. 

Seqster and Takeda announced an extended agreement to improve patient outcomes through better access and understanding of patient-level data. Seqster will provide Takeda with instant access to its secure platform to visualize longitudinal electronic health records (EHRs), genomic profiles (DNA), and wearable/fitness data across health systems for individual patients. Seqster's technology supports real-time, real-world data and targeted patient engagement, which includes FDA 21 CFR Part 11 compliance, and the decision support system and research platform dramatically reduces the time for consenting and onboarding patient data during clinical trials. This enhances patient engagement and compliance through a single-entry point for EHRs and integrates with partners enterprise data backbones. Press release.

BEKHealth has released BEK Translate Real-Time, which alerts clinical researchers in real-time when patients have a time-sensitive medical event required for eligibility. BEK Translate Real-Time is especially needed in today’s COVID healthcare environment where it is particularly challenging for doctors, clinical staff, and patients to coordinate research in a timely and safe manner. Research sites benefit from streamlined patient pre-screening, higher enrollment, and improved researcher to MD coordination. Press release. 

Medidata, a Dassault Systèmes Company, has launched myMedidata LIVE, a new feature on the myMedidata patient portal. myMedidata LIVE is a web-based, live video conferencing capability connecting patients virtually with their clinical trial study staff. Built on the industry’s leading Rave EDC (electronic data capture) platform already in use at more clinical research sites globally than any other system, myMedidata LIVE gives researchers and patients a way to engage in remote site visits within the platform of site and patient-facing technologies they are already using on the study. Press release.

Caris Life Sciences has launched CODEai (Comprehensive Oncology Data Explorer), using an advanced Artificial Intelligence (AI) backbone. CODEai is a real-world clinico-genomic data platform that integrates Caris’ extensive catalog of molecular data with cancer treatment information and clinical outcomes data for over 215,000 patients covering over 1,000,000 data points per patient. Integrating Caris’ database of profiled patient cases with associated treatments and outcomes, CODEai allows for customized cohort analysis based on a variety of search queries that include Caris’ industry-leading molecular profiling results, demographic data, diagnostic data, and treatment and survival data. CODEai provides accurate data visualization and advanced predictive analytics to deliver clinicians, researchers and scientists with personalized and precise cancer insights that can lead to better understanding of how different cancers respond to treatments. Press release. 

Oracle Health Sciences and FHI Clinical have joined efforts to improve clinical trial efficiency and help get therapies to market faster. FHI Clinical has adopted Oracle Health Sciences Clinical One for randomization, supply management, and data collection. The company also uses Oracle Argus Safety for safety case management; Oracle Clinical Trial Management System (CTMS) Cloud Service to manage the entire research portfolio, including study status and financial reporting; and Oracle ClearTrial Cloud Service to help budget, plan and bid on projects. Press release.

Lyft has worked directly with Epic to create the Lyft for Epic integration, enabling health system staff to schedule a Lyft ride for a patient directly from that patient’s record. Lyft for Epic integrates Lyft Concierge directly into Epic, making it easier for healthcare staff to order a Lyft ride on behalf of a patient. Staff can send reliable rides directly from a patient’s profile in the EHR, and patients can easily get to their appointments and back home after the visit without needing an app. Press release.

Elsevier has launched Transition to Practice, an immersive online learning platform that empowers new nurses to build skills and confidence as they transition from academia to professional clinical practice. With the COVID-19 crisis still in effect, Transition to Practice is launching at a time when clinical environments are even more demanding than before. Aligning with the American Nurses Association (ANA) Standards of Professional Practice, Transition to Practice presents an evidence-based curriculum with cutting-edge eLearning modules such as virtual simulation and interactive games to accelerate competence and sharpen decision-making skills for new nurses. To promote a culture of support, the platform also features communication tools that allow new nurses to self-reflect on levels of confidence and share the support they experienced during recent shifts with their leaders. Press release.

The first biobank in Australia aiming to improve research and treatments into rare genetic diseases caused by changes to genes on chromosome 15, including Prader-Willi Syndrome and Angelman Syndrome, will be established at the Murdoch Children’s Research Institute (MCRI). Prader-Willi Syndrome (PWS) and Angelman Syndrome (AS) are considered to be rare diseases found 1 in 15,000 in the general population. PWS is a leading cause of life-threatening obesity, while AS is associated with severe seizures that can be lethal. MCRI researchers and their national collaborators will recruit 100 people over three years with PWS and AS and collect biological samples from different tissues such as blood and skin cells, which will be linked to family/clinical histories, and perform detailed clinical and psychological assessments. Press release.

Cytel has launched Solara, a collaborative decision-support platform that revolutionizes the identification of optimal clinical trial designs. The patent-pending platform applies massive cloud computing power to Cytel’s proven statistical design engines to explore an exponentially larger study design space than is possible using traditional methods. The new platform also integrates critical non-statistical considerations and uses interactive visuals to streamline collaboration. Early usage of Solara has consistently uncovered opportunities to reduce trial duration by 10-20% without compromising cost or probability of success. Press release.

KenSci has launched their AI Platform for Digital Health that helps healthcare organizations accelerate their journey from business intelligence (BI) to AI to return on investment (ROI). The re-imagined AI platform extends KenSci's runtime engine with BI-AI development capabilities and the latest predictive analytics technology that enables health organizations to develop BI and AI-based workloads in an easy and agile way. Built specifically for healthcare, KenSci's AI Platform for Digital Health is an interpretable, integrated, and simplified data platform which powers operational and clinical workflows with AI based insights. The KenSci solution enables users to rapidly build their own customized AI-enabled use cases or deploy KenSci solutions built into the platform. Press release. 

Digital Science has partnered with Google Cloud to remove barriers to data access, analysis and visualization for organizations across the research and innovation ecosystem. With its new integration, the Dimensions database is now available to be analyzed on BigQuery, Google Cloud’s serverless, highly scalable and secure multi-cloud data warehouse. Dimensions provides a comprehensive view of the research and innovation landscape. Updated daily, it currently contains 112m publications linked to 1.3bn citations, 5.5m grants worth $1.7 trillion in funding, 41m patents, 600k clinical trials, over 120m Altmetric data points. BigQuery provides companies with a modern, serverless, and highly scalable data warehouse. Through the integration with Dimensions, it gives these joint users an unprecedented flexibility to access the data in Dimensions, but also allows anyone in the research world to connect external datasets to Dimensions privately and securely. These datasets could be an organization’s own private data, or important scientific databases such as ChEMBL. Press release.

Lantern Pharma has announced a collaboration and research agreement with Fox Chase Cancer Center for the further development of Lantern's LP-184 in pancreatic cancer. The Fox Chase collaboration will focus on advancing the targeted use of LP-184 in molecularly-defined sub-types of pancreatic cancer. The goal of the collaboration is to create a more biologically relevant and robust gene signature in preparation for future clinical trials, enabling pancreatic cancer patients to potentially benefit from a more effective and personalized cancer therapy. Press release.

The University of California, San Francisco (UCSF) will be utilizing VivaLNK’s continuous wearable ECG sensor for a 3,000 subject multi-year study on atrial fibrillation (AF). Spanning up to 10 years, the study aims to detect biomarkers of early atrial transformation in AF. Subjects in the study will be monitored using the VivaLNK wearable ECG sensor, which can capture ECG and heart rate on a continuous basis 24 hours a day. Each subject will wear the ECG sensor for about one week every month, even while ambulatory or at home. Data from the sensor will then be captured through a mobile app and sent to the cloud for analysis. In addition to capturing ECG rhythm and heart rate, the VivaLNK sensor can also derive respiratory rate and offer accelerometer data. The same sensor is used in other applications and studies, such as in-hospital patient monitoring, remote patient monitoring, heart failure event detection, and chemo treatment event detection. Press release.

Samsung Medison and Intel are collaborating on new smart workflow solutions to improve obstetric measurements that contribute to maternal and fetal safety and can help save lives. Using an Intel Core i3 processor, the Intel Distribution of OpenVINO toolkit and OpenCV library, Samsung Medison’s BiometryAssist automates and simplifies fetal measurements, while LaborAssist automatically estimates the fetal angle of progression (AoP) during labor for a complete understanding of a patient’s birthing progress, without the need for invasive digital vaginal exams. Press release.

Inato, a global industry marketplace that matches research sites to the right clinical trial protocols, announced 300 clinical trial research sites have joined its recently launched Marketplace, which is comprised of research centers, hospitals, medical practices and other organizations from multiple countries including the United States, France, the United Kingdom, Germany, the Netherlands and Brazil. Using a data-driven approach, coupled with a high-touch qualification and support process, the Inato Marketplace flips the traditional selection model of sponsors repeatedly tapping the same few sites and instead provides all research sites the opportunity to search and match for trials based on their qualifications, interests and patient needs. The Marketplace also matches trial sponsors that need to fill research gaps or expand access to innovative, investigational medicines with experienced sites and research centers. Press release. 

Clinerion and Maxer Consulting partner to boost the identification and the recruitment of patients into clinical trials in Italy and promote safer and more effective clinical outcomes.

Clinerion's Patient Network Explorer will leverage Maxer's extended network of relations in the international healthcare sector to access promising business opportunities and expand Clinerion’s patient coverage into Italy, promoting and delivering clinical trials-related solutions.

Clinerion and Maxer will cooperate to engage clinical trial sponsors to fully exploit Patient Network Explorer’s potential and provide added-value services arising from Maxer’s experience in clinical data management, regulatory affairs, medical affairs, clinical trial disclosure and data transparency, and medical writing services. The partners' joint mission is to liaise with study sites to increase patient participation in trials to its full potential by offering tools to optimize protocol design, supporting the efficient start-up of local trials, and planning and consistently hitting realistic patient recruitment targets to enable the achievement of total timeline targets. The geographic scope of the partnership is primarily focused on Italy but will extend to other countries as opportunities arise. Press release.