June 29, 2021 | Partnerships and acquisitions in decentralized clinical trials, risk stratification, AI in clinical research, digital health, and more. Plus new products from Smart Meter, Medidata, Cmed, and Pharmasol.

The Luxembourg Institute of Health (LIH) announces the launch of CoLive Voice, a first-of-its kind digital health study that aims to advance the diagnosis, risk prediction and remote monitoring of various chronic conditions and symptoms by evaluating voice features. Leveraging breakthrough artificial intelligence approaches, the study will collect and analyse voice recordings in several languages from both the general population and people living with chronic or infectious diseases, to identify so-called ‘vocal biomarkers’. CoLive Voice is led by the Deep Digital Phenotyping research unit of the LIH Department of Population Health (DoPH) and is set to run for up to 10 years. Press release.

Lightship and Castor, leading providers of decentralized clinical trial solutions, have announced a strategic partnership to run direct-to-patient (hybrid) clinical trials at scale. The partnership combines operational excellence in clinical studies and technology that delivers for the most complex clinical trials. Lightship’s end-to-end delivery model combined with an in-house care team provide the best possible patient experience in clinical trials. By partnering with Castor’s proven, globally compliant Decentralized Clinical Trial and Clinical Data Management platform, Lightship is strengthening its commitment to deploying best-in-class virtual tools. Lightship’s focus on the patient at every step, from recruitment through to study completion and beyond, is supported by the Lightship patient application. Lightship and Castor will work in close collaboration on clinical studies, providing a seamless experience for physicians, nurses, and study coordinators. The partnership enhances the speed and simplicity of building clinical studies, data integration, and real-time reporting. Press release.

Recuro Health has acquired MyLegacy, a risk stratification tool and clinical decision support application which uses proprietary algorithms based on practice guidelines developed by the Cleveland Clinic Genomic Medicine Institute. The acquisition further increases the scope and capabilities of Recuro’s digital health platform, pairing automated genetic data gathering with complex care planning to save time, make care more precise and streamline the full continuum of care. Rich genetic and genomic risk stratification supports the Recuro integrated digital approach to disease management. By integrating these software tools, Recuro helps employers and payers identify complex and chronic diseases. Access to this data supports the work of coordinators who may not have access to important genetic risk factors or genetic testing results. Press release.

Medable has named Sanskriti Thakur as chief growth officer. Thakur most recently served as global life sciences research lead for Accenture, responsible for market-shaping strategy and research in therapeutics, digital health, and business model innovation. Notably, she was responsible for perspectives in new science, COVID-19 responses, and clinical trial diversity. During her 18 years in the life sciences industry, Thakur has advised more than 30 life science companies, launched 10 life science products, advised digital health venture funds, and managed a leading pharmaceutical portfolio. She has authored 12 publications on various industry topics, and currently serves on the World Economic Forum global futures council for healthcare topics. At Medable, Thakur will focus on market expansion and growth initiatives to advance Medable’s vision of human-centered research, enabling remote access to clinical trials regardless of geography, income and race. The growth initiatives will support expansion of Medable’s strategy across geographies and new markets. Press release.

Medable has also announced an industry-first digital certification program that provides life sciences companies with specialized tools, knowledge sharing and skills development to rapidly scale their decentralized and hybrid trial strategies. Medable’s certification program supports partners to codify emerging skills and learning paths that empower individuals and teams to design, build, deploy and support decentralized and hybrid trials. Press release.

Smart Meter has launched iScale, a cellular-connected body weight scale. This addition further expands its suite of healthcare products, which include iGlucose for diabetes monitoring and iBloodPressure for hypertension management, to enhance traditional chronic condition management. By delivering cellular-connected products with real-time data transmission, Smart Meter is now a one-stop shop for enabling remote patient monitoring, population management, telehealth, and home care. Smart Meter’s use of cellular-connected devices ensures healthcare providers and partners receive accurate, real-time, and dependable data, with no extra steps necessary. This is imperative for better patient engagement, ease of use and reliability of data transmission. Press release.

Medidata has launched the Medidata Decentralized Clinical Trials (DCT) Program, the most comprehensive set of unified, secure technologies that enable full decentralization across the clinical trial continuum. For the first time ever, drug, vaccine, and medical device developers (sponsors) and contract research organizations (CROs) can take advantage of the only platform offering on the market which combines technology and workflows to virtualize patient participation, tools that facilitate sponsor oversight of patient safety and data quality, and direct-to-patient services, including facilitation of delivery of study drugs to the home. The Medidata DCT Program captures participant data remotely from anywhere, at any time. It aggregates and transforms that data, monitors the data to identify quality issues to mitigate risk and ensure patient safety, and runs powerful analytics to draw new insights leading to better outcomes for patients, researchers, sites, sponsors, and CROs. Press release.

Medidata has also launched myMedidata Registries, a new technology that expands and strengthens the myMedidata patient portal to engage patients before and after (i.e., long term follow up/safety surveillance) a clinical trial. With increasing interest and adoption of decentralized clinical trials, myMedidata Registries gives patients continuous support in and out of a trial with access to one portal for all of their research needs, providing an everlasting engagement on one portal for life. Built directly on the Medidata Clinical Cloud, myMedidata Registries provides education, pre-screening, patient data collection, and opportunities for video visits before a patient travels to a site or is enrolled into a study. Clinical trial sponsors and CROs using myMedidata Registries have a direct, secure connection with trial participants via notifications and alerts, allowing them to optimize trial participation, and increase product and trial awareness. Press release.

Elligo Health Research has acquired Root Health, an AI virtual assistant for clinical research. The acquisition of Root Health adds to Elligo’s commitment of building a technology-forward, integrated healthcare-enabling research organization with a full range of capabilities to improve the efficiency of clinical research and is designed to support easy access for faster enrollment and accelerated trials overall. Press release.

Global professional services firm ZS is acquiring Medullan, a leader in digital health and digital medicine strategies and solutions. The acquisition paves the way for offerings that will help drive the success and scale of digital health solutions for better patient outcomes. It will achieve this by combining ZS’s existing consulting, technology and analytical services in life sciences with Medullan’s innovative digital health solutions, as well as its pioneering virtual care and decentralized trial platform, VARA. The complementary capabilities of ZS and Medullan promise to help realize the potential of this growing field of commercialized digital health solutions and decentralized trials. When the transaction is finalized, Medullan’s 80-plus employees will join ZS’s DCH practice. Press release.

Certara has acquired Insight Medical Writing, based in Oxford in the United Kingdom. Financial terms of the transaction were not disclosed. Founded in 2002, Insight Medical Writing offers regulatory services and medical writing. Its medical writers are all PhD trained and come from diverse backgrounds such as molecular biology, oncology, and pharmacology. The acquisition expands Certara’s regulatory science capabilities in the UK and Europe. Press release.

ObvioHealth is bringing clinical trial data fully into the continuum of care through a new strategic partnership with Dedalus Group, the leading healthcare and diagnostic software solutions provider in Europe. The partnership will unite ObvioHealth’s proprietary decentralized clinical trial tools with Dedalus’s software solutions, connecting the dots between clinical research and EHR (Electronic Health Record) data while supporting healthcare providers from 6000+ hospitals and clinics across the world to deliver care to more than 330 million patients. The initial stage of the partnership will allow sponsors and other research organizations to collaborate with HCPs who can provide meta-data insights from patient records without moving or revealing any actual EHR data. This will enable researchers to conduct granular prognostic and predictive analysis for improved study design and recruitment of more precise subpopulations of patient cohorts, giving healthcare professionals and their patients the opportunity to contribute to and/or participate in research, while maintaining full control of their data, in compliance with stringent European privacy and data safety regulations. The partnership will also offer researchers data services outside the boundaries of traditional clinical trials for the purposes of training AI enabled tools and/or developing diagnostic instruments that can provide deeper and/or longitudinal analysis of certain disease states. In parallel, the collaboration will enrich healthcare provider insights by integrating point in time clinical research into the daily workflow of Dedalus’s network of hospitals. Press release.

Algorics has acquired Domain Clinical Data Sciences "DCDS", a clinical data services organization based in India. The acquisition supports Algorics' commitment to expanding its team of experienced analytical professionals and sustaining its commercial growth. The acquisition brings Algorics' headcount to 60 and expands the company's geographic footprint with a new location in Hyderabad. The deal builds on 12 months of significant growth for Algorics in which it has brought on board an experienced leadership team, hired new talent, and added new clients to its portfolio. Press release.

Cmed Technology has announced increased capabilities for encapsia, its advanced enterprise, cloud-based clinical data system, after increased demand for its use in decentralized trials. Encapsia delivers a complete solution to gather and manage multiple live clinical data sources and apply real-time data management, sophisticated visualizations, analytics, and AI. Encapsia was designed to address the pain around remote collection, integration, and availability of disparate data. This includes powerful visualizations to provide greater oversight, down to the source data level, to allow immediate action and optimize your trial. In one platform you can collect data via the web or iPad app (EDC, Home Visit, and eSource), manage, visualize, and analyze all your clinical data from the portfolio to patient level. Press release.

Pharmasol has announced the availability of psiXchange version 2.4, which automates the safety document distribution process within clinical trials. psiXchange is a dynamic safety data communication hub for drug safety document management and an automated system that establishes relationships between data from multiple sources. The new enhancements within this release include expanded site views, enabling better support of clinical operations and site-based teams that provide enhanced information in real-time to a variety of global recipients involved in the drug safety management chain. Press release.