January 4, 2021 | Launch of the Decentralized Trials & Research Alliance, acquisitions focused on decentralized trials and remote administration, new wearables for remote monitoring, better training for nurses in clinical settings, and more.

The Decentralized Trials & Research Alliance (DTRA) has launched, planning to unite stakeholders, including healthcare companies, regulators, patient groups and research organizations, with a mission to make clinical trial participation widely accessible by advancing policies, research practices and new technologies in decentralized clinical research. Experts estimate that COVID-19 may set back non-pandemic clinical trials by several years due to prospective patients’ inability or reluctance to schedule visits at physical research locations. Decentralized approaches to conducting research facilitate participation by a more diverse patient population and could ease COVID-19-imposed difficulties for both patients and clinical investigators. Press release. Parexel is one of the founding members. Press release. 

Clinical trial software provider Teckro introduces Teckro Connect as the newest application in its digital engagement platform, giving research site staff direct and immediate access to study experts. Time delays and a lack of trust in the information provided cause unnecessary frustration for research site staff. Teckro addresses this frustration through a combination of mobile self-service access to all study documents with Teckro Search and a secure, dedicated communication channel for research staff to directly query study experts with Teckro Connect. With Teckro Connect, research staff can ask for clarification or confirm information from the secure Teckro mobile application. The message is received by a dedicated group of medical and scientific experts, giving everyone involved transparency into the response. This leaves no question unanswered and gives staff confidence in the fidelity of the information. It also provides a thread of communication for further clarification, if necessary. Press release.

Signant Health has acquired VirTrial, a leading provider of software solutions for remote site startup and decentralized clinical trial conduct. By adding the capabilities of VirTrial, Signant Health now expands its software stack to further digitally enhance trial sites and offer sponsors superior evidence generation across traditional, decentralized, and hybrid trial models. Signant Health's comprehensive suite of technology and clinical expertise, combined with VirTrial's telemedicine platform, will better support sites as sponsors accelerate their trial strategies toward digital methods during COVID-19 and beyond. Press release.

Advarra has acquired Longboat, an innovative provider of clinical trial technologies focused on site training, protocol compliance, and patient engagement. The addition of Longboat, headquartered in Dublin, Ireland, enables Advarra to offer a broader suite of technology solutions to sites, biopharmaceutical companies, and clinical research organizations (CROs) globally, through a site-centric approach, driving increased efficiencies and compliance in clinical trials. Longboat’s user-friendly, integrated platform helps to simplify trial conduct and participation, increase study compliance and, ultimately, accelerate clinical trials. Longboat provides study teams with comprehensive oversight of and engagement with sites globally, enabling swift action to keep studies on track. Press release.

Amgen will expand adoption of Reify Health’s StudyTeam across the biopharma’s global research portfolio. Initially, Amgen deployed Reify Health’s StudyTeam software to trials across multiple indications. Amgen wanted to reduce the amount of manual work sites manage during recruitment and to automate information sharing between sites and Amgen’s clinical trial teams. They also sought to provide their trial teams with new insights into trial-wide enrollment trends to inform enrollment planning and management decisions. Success on these initial studies led to expansions across all of Amgen’s therapeutic area programs. Reify Health makes StudyTeam available to clinical research sites to centrally manage and track an array of recruitment and enrollment activities and information, such as pre-screening activity, recruitment progress, and the impact of I/E criteria on enrollment. Sponsor trial teams like Amgen’s can then access that information securely to view site-by-site pre-screening status and activity, monitor the success of various recruitment strategies, and take earlier action such as making protocol amendments, deploying backup sites, or reallocating recruitment budget. Press release.

VivaLNK has announced the newest addition to its medical wearable platform, the Vitals Data Service. This turnkey service is designed for clinical trials and healthcare applications in remote or clinical settings. The Vitals Data Service includes VivaLNK’s line of FDA-cleared ambulatory medical wearable sensors, a customizable remote patient monitoring app, cloud and data concierge services for consolidated data access in customizable data formats. It is designed for fast and easy continuous data capture in remote locations even in the event of intermittent network disconnections common in ambulatory situations. Data captured from patients are sent to a centralized cloud service that offers both on-demand and retrospective data access. Press release.

Velocity Clinical Research has acquired eStudySite, adding two sites in San Diego, California, to its North Carolina-based site portfolio, bringing the total to 14. The La Mesa and Chula Vista sites will make significant contributions to Velocity’s drive to recruit more volunteers from minority communities. The acquisition comes amid Velocity’s participation in COVID studies where it is seeking to recruit over 20,000 volunteers across 10 of its existing sites. The acquisition also expands Velocity’s testing capabilities in preventative treatments. The new sites in La Mesa and Chula Vista are enrolling patients for both COVID-19 treatment and COVID-19 vaccine trials. Press release.

The Verisense Inertial Measurement Unit (IMU) sensor from Shimmer Research is now a CE certified, Class I medical device (#22286). The Verisense IMU plays a central role in Shimmer’s Verisense wearable sensing platform, which was developed from the ground up for use in clinical trials. Verisense addresses the needs of, and places minimum burden on, all clinical trial stakeholders – sponsors, clinical research organizations (CROs), site staff and participants. For sponsors, Verisense captures continuous raw data for all the clinical trial metrics, ensuring that they have everything required for their regulatory submission package. It also delivers maximum data reliability and advanced trial management tools for easy use and increased data accessibility, transparency and security.

Tilak Healthcare, a digital therapeutics pioneer specializing in the development of mobile medical application games used as monitoring and rehabilitation tools for chronic diseases, is proud to announce a framework agreement with Novartis Pharma AG for the promotion internationally of Tilak Healthcare’s first clinically validated mobile app for patient remote vision monitoring, OdySight. OdySight is an engaging smartphone application used to monitor and engage patients with chronic eye diseases associated with aging. The app is available by prescription and includes accurate vision tests and fun puzzles to boost patient engagement. Adapted to patient needs, the app serves as an important link in strengthening the patient-clinician relationship. Having successfully launched a joint promotion with Novartis France in 2019, Tilak Healthcare and Novartis Pharma AG wish to make OdySight well-known and accessible to many more patients by expanding the co-promotion internationally. Press release.

The National Kidney Foundation and Renalytix AI are partnering to improve kidney disease diagnosis and assessment in the earliest stage of the disease that will ultimately guide clinical interventions and treatments for improved outcomes and quality of life. Renalytix AI’s KidneyIntelX is an in vitro diagnostic platform that uses a machine learning enabled algorithm to interpret proprietary biomarkers from a simple blood draw and electronic health record features to generate a patient specific risk score for disease progression. The KidneyIntelX risk score categorizes a patient as low, intermediate or high risk for kidney disease progression and kidney failure. The individual patient's score will be integrated with risk appropriate NKF recommended clinical actions and education resources as part of a comprehensive approach to improve outcomes. NKF and RenalytixAI will collaborate on future studies to assess current care standards in early stage kidney disease, identify barriers to better care and opportunities for improvement. Long-term initiatives will be developed as the partnership unfolds. Press release.

Elsevier has acquired Shadow Health, a Florida-based developer of virtual simulations in nursing and healthcare education. Shadow Health’s Digital Clinical Experiences train and prepare nurses and healthcare practitioners for clinical settings. Its cutting-edge simulations, powered by Shadow Health’s Conversation Engine, enable learners to practice and apply their clinical reasoning skills through life-like interactions with a diverse range of virtual patients. Engaging in conversation-based learning, students gain confidence by practicing the skills they need to care for patients in a safe and standardized environment. The addition of Shadow Health enhances Elsevier’s extensive portfolio of digital health solutions at a time when experts are calling for improved communication skills from healthcare providers and nursing students. Press release.