May 3, 2021 | Mergers and strategic collaborations link data from devices and sensors, streamline research workflows, and aim to accelerate clinical trials. Plus, updated CTMSs, expanded CROs, and more new products and updates from around the industry.

National Institutes of Health is funding $29 million in additional grants for the NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities. This funding was supported by the American Rescue Plan. The awards will provide $15 million to 11 teams already conducting research and outreach to help strengthen COVID-19 vaccine confidence and access, as well as testing and treatment, in communities of color. An additional $14 million will fund 10 new research teams to extend the reach of COVID-19 community-engaged research and outreach. Press release.

ERT and Bioclinica have closed their merger, first announced in December. The transaction combines Bioclinica’s expertise in imaging, eClinical software and drug safety solutions with ERT’s expertise in eCOA, cardiac safety, respiratory and wearables. By joining forces, ERT strengthens the most comprehensive and robust endpoint data collection portfolio in the industry with greater integrated and digital solutions across essential endpoints—including imaging, respiratory, cardiac, eCOA with connected devices, as well as precision motion. Press release.

Bioclinica recently launched Source Document Manager, a comprehensive solution to enable clinical trial sponsors and contract research organizations (CROs) to collect, de-identify, translate, organize, and manage source documents seamlessly using a secure, cloud-based application. The new product generates notable efficiencies at research sites and eases global trial management in the areas of patient eligibility, routine electronic data capture (EDC), clinical adjudication, and source document verification. Bioclinica Source Document Manager supports online protected health information redaction at the site level with verification by a team of quality control experts and boasts direct integration with a premier online translation service to translate source documents. Additional features include structured and guided data collection, multilingual platform, AI-aided redaction, query management, advanced search capabilities, and complete audit trail. Bioclinica Source Document Manager can be used as a standalone data collection and storage module to collect and review source documents online, or it can be integrated with an existing EDC system or other data tracking system to send redacted and quality-controlled source documents to their destination. Press release.

St. Jude Children’s Research Hospital is launching the largest strategic investment in its nearly 60-year history, committing $11.5 billion during the next six years to accelerate research and treatment globally for children with catastrophic diseases. The Six-Year St. Jude Strategic Plan focuses on the expansion of patient care and clinical and laboratory-based research related to pediatric catastrophic illnesses, including work in cancer, blood disorders, neurological diseases and infectious diseases. The plan calls for an additional 1,400 jobs; the expenditure of $1.9 billion in new construction, renovation and capital needs; and the development of new research areas. Press release.

Organicell Regenerative Medicine has announced positive results for the first ten COVID-19 patients treated with Zofin in India. This initial trial is being conducted in conjunction with Organicell's Indian partner, CWI India, with whom Organicell entered into a product testing and distribution agreement on February 9, 2021 to study the effects of Zofin on moderate to severe COVID-19 patients. The initial ten trial participants were hospitalized patients and were treated at Narayana Hrudayalaya Hospital in Bangalore, Lisa Hospital in Kozhikode, Kerala and Prime Indian Hospital in Chennai, and all patients have recovered from their symptoms and have since been discharged from the hospital. Based on the initial results of this trial, the trial will be expanded to an additional sixty-five patients with moderate to severe COVID-19, who will be treated at these hospitals over the next several weeks, with treatments expected to be completed by the end of June 2021. If the results of the expanded trial are similarly positive, Organicell and CWI India, intend to file with the ICMR (Indian Council for Medical Research) for Emergency Use Approval to use Zofin in India as a therapeutic for treating COVID-19. Press release.

BC Platforms (BCP) has announced a new strategic partnership with US-based company TripleBlind to help drive the development of privacy and intellectual property rights (IPR) preserving “federated AI” for its BCRQUEST.com Global Data Partner Network. The partnership will enhance BCP’s contribution to the Finnish-led PRIVASA (Privacy Preserving AI for Synthetic and Anonymous Health Data) consortium. The two-year PRIVASA project aims to promote access to, and sharing of, anonymized health data to accelerate product development by Finnish health technology companies operating in international markets. BCP will be contributing federated AI learning approaches to train machine learning algorithms without the need to exchange actual data. This method will enable BCP to address data governance and privacy requirements, as individual-level data never needs to leave its institution of origin. BCP’s partnership with TripleBlind will further improve this federated AI concept by ensuring IPR protection, encrypting analyses and results using its proprietary cryptographic technology. Press release.

BCP has also announced the launch of the new Cohort Discovery (CD) search functionality on the Health Data Research (HDR UK) Innovation Gateway (The Gateway) – powered by BC|RQUEST technology in partnership with HDR UK. The CD functionality enables global researchers to discover, assess, and request access to datasets by searching for specific cohorts or demographic groups across multiple datasets. CD facilitates access to data in a fast, secure, de-identified and ethical way through Trusted Research Environments: safe and secure locations from which researchers can access and analyze data, without needing to move the data around. The function will be rolled out across all the 640 datasets on The Gateway, with COVID datasets being prioritized initially. Press release.

Parexel and Veeva Systems have announced a strategic collaboration to accelerate clinical trials through technology and process innovation. As part of the partnership, Parexel is standardizing on Veeva’s suite of clinical operations applications, including Veeva Vault eTMF, Vault CTMS, and Vault Study Startup to streamline operations. Veeva Vault CDMS for clinical data management will also become a standard offering available from Parexel to its customers. With insights from sponsors, sites, and patients, the companies will collaborate to continuously improve Veeva’s cloud technology and Parexel’s processes for delivery of clinical trials. Parexel will have early access and provide input into Veeva’s clinical products, including innovations to support sites and patients in decentralized clinical trials (DCT), risk-based quality management (RBQM), and community-based sites. Press release.

eClinical Solutions has announced that Translational Research in Oncology (TRIO), a global academic clinical research organization (CRO), has selected eClinical’s elluminate clinical data platform to modernize trial processes across its network of 700+ cancer centers. The adoption of elluminate by life sciences organizations including CROs is increasing across the industry to drive digital transformation strategies by unifying data sources into a centralized platform that enables real-time access and analysis to clinical data from ingestion to insights. Press release.

Calyx has announced Calyx CTMS v15.0, an advanced clinical trial management system for reducing risk and improving efficiencies in clinical development. Calyx CTMS on Microsoft's Azure cloud technology delivers robust features that simplify the oversight of clinical trial operations, improve data quality, and reduce trial timelines and cost. Some of the features of CTMS v15.0 enable trial sponsors to: better manage clinical trials in today's changing landscape with tools that address the complexities of traditional and decentralized clinical trials, centralize the operational data of current and historical trials into a single source, providing actionable insights to support informed decision making and drive trial success, boost productivity by seamlessly connecting to the clinical development ecosystem through standard and custom API integrations, and conduct monitoring visits anywhere, regardless of internet connectivity via the smartphone- accessible Calyx CTMS mobile application. Press release.

Wellframe and Validic have announced a strategic collaboration, empowering Wellframe members to integrate medical device data within the Wellframe mobile app. This integration with Validic will first enable Wellframe users to track their blood glucose levels across 50 glucometer devices, right from the Wellframe app. Wellframe’s ability to collect meaningful biometrics data from their digital care management platform allows for more touchpoints with care teams and actionable care plans. Wellframe’s new integration via Validic enables Wellframe customers to provide even more comprehensive, seamless care management by easily capturing information from the most widely used, affordable devices that are used by the most people. Press release.

LINK Medical, the Northern European clinical research organization (CRO), is continuing the expansion of its German presence. This further strengthens their position as a gateway between the Nordics and one of the largest medical device and pharmaceutical markets in Europe. By establishing a stronger position in Germany, LINK Medical’s global clients get access to Germany’s well-recognized regulatory authorities, its vast network of clinical trial sites and investigators, and Europe’s largest patient population—all key elements for performing high-quality clinical trials. LINK Medical provides a full range of product development services for the pharmaceutical and medical device industries. With offices across the Nordic countries, Germany and the UK, LINK Medical operates as a single source of expertise to support clients located all over the world. Press release.

Cofactor Genomics has begun the first multicenter clinical trial of its OncoPrism diagnostic assay using the company’s patented approach to generating multidimensional immune biomarkers. Fifteen hospitals and healthcare networks, including Mayo Clinic, MultiCare Institute for Research and Innovation, and Revive Research Institute, are currently enrolling in the PREDAPT (Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies) Trial to evaluate use of the OncoPrism test in patients with recurrent and metastatic squamous cell carcinoma of the head and neck (RM-HNSCC) to effectively predict a patient’s response to immunotherapy. The company expects additional sites to join the trial before the end of 2021. While the trial will initially recruit RM-HNSCC patients, the protocol is approved for recruitment of patients with 10 additional indications where independent market research has identified an unmet clinical need in predicting tumor response to immunotherapy. Specimens collected in the study will be analyzed at Cofactor’s CAP/CLIA accredited laboratory. Press release.

Reify Health and SubjectWell have launched a partnership aimed at streamlining the workflow of research sites to manage patient referrals from sponsor-driven recruitment campaigns. With this pairing, referrals from SubjectWell’s marketplace are delivered directly into Reify Health’s StudyTeam, offering a common platform for sites and sponsors to manage pre-screening, enrollment, and reporting for clinical trials. Sites are then empowered to update, manage, and report on the entire enrollment funnel from a single, secure, and easy-to-use platform. The combined SubjectWell and Reify Health solution, used across more than 5,000 sites globally, matches the strength of risk-free patient recruiting with a streamlined site workflow solution to create a stronger enrollment funnel that reduces burden for sites and increases randomization rates for sponsors. Several leading biopharmaceutical sponsors, including Eli Lilly and Company, are already leveraging the partnership between Reify Health and SubjectWell to improve referral workflows and accelerate enrollment for key trials across their research portfolios, the companies reported. Press release.

Reify Health also announced that AstraZeneca has selected StudyTeam to accelerate clinical development across its breast cancer investigational therapy portfolio. Since 2019, AstraZeneca has deployed Reify Health’s StudyTeam across multiple large global oncology clinical trials. High site engagement, supercharged workflows, and more visibility and control went into AstraZeneca’s decision to expand usage of StudyTeam. Press release.

2bPrecise added functionality in the 2bPrecise winter 2021 release. Notable features include: introduction of an innovative 2bPrecise Precision Timeline, enabling clients to access previous tests, diagnoses, labs and notes in a single view to eliminate time-consuming “document hunting” during clinical decision-making; PGx candidate identification support to determine patient cohorts at greatest risk for drug-gene interactions (especially in those taking multiple medications); broader PGx knowledgebases to incorporate the latest medication ontologies and scientific discoveries; additional lab integrations to enhance insights from tumor test results (somatic), including identification of additional biomarkers and chromosomal alterations; and functionality that allows clinicians to easily search for negative genetic/genomic findings to easily determine if a specific condition or genotype was covered by an ordered test. Press release.

RegDesk has released an updated version of its 'Dash' platform. Dash 2.0 incorporates an innovative application builder that cuts the submissions process from months to hours and facilitates faster approvals. Registering medical devices has become increasingly challenging in recent years as nations struggle to update regulations in response to rapid technological advances in the industry. The result is labyrinthine approval processes that often differ from country to country. RegDesk's application builder uses AI-powered software to automatically prepare submissions dossiers and autofill applications with archived product and regional targeting information. Internal data shows that with one click, on average, 40-50% of certain applications can be completed. Besides faster application building, the tool also ensures greater compliance with individual nations' regulatory requirements. RegDesk utilizes the largest and most up-to-date global regulatory intelligence database on the web to guide users through the application process, potentially saving devices from years of regulatory limbo. Press release.

Thirona has developed an AI algorithm that revolutionizes cystic fibrosis (CF) care. The new algorithm, coined PRAGMA-AI, allows for fast, automated analysis of CT scans of patients with CF to detect and quantify lung abnormalities related to CF. These quantifications are critical in determining the status of the patient and determine optimal treatment paths but are not feasible to be performed by humans in clinical care. The release of PRAGMA-AI paves the way for large-scale usage in clinical trials and clinical care for better diagnostics, patient monitoring, and treatment planning. Press release.

Smart Meter, makers of the iGlucose cellular-connected blood glucose monitoring system, today announced its partnership with PointClickCare, the leading cloud-based healthcare software for the long-term and post-acute care market. Through this partnership, care providers can now view patient blood glucose data in one Electronic Health Record (EHR) platform, eliminate manual glucose data entry or uploading, and reduce errors when using the iGlucose system during COVID-19. Smart Meter integrates with PointClickCare’s core EHR platform and will be listed as an integrated offering on the PointClickCare Marketplace. Designed to capture real-time glucose results and enable customers a singular view of patient information, this collaboration is particularly important for remote patient management, a practice that has seen exponential growth as a result of desires to limit patient interactions during COVID-19. Press release.

Advarra has acquired Bio-Optronics, maker of CCTrialSuite, which includes Clinical Conductor, the leading clinical trial management system (CTMS) for health systems and research sites, and an integrated suite of eClinical solutions. The acquisition, in combination with Advarra’s existing suite of products and services, establishes Advarra as the site technology market leader with extensive reach, customer loyalty and the highest standards of customer support to the 50,000 investigators whose sites run on Advarra software. With the acquisition of Bio-Optronics, Advarra builds on its established relationships with academic medical centers, cancer centers, and sites through its OnCore CTMS to now include a broader coverage of site networks and health systems of any size as well as commercial sites supported by CCTrialSuite. Additionally, the acquisition enhances Advarra’s deep commitment to clinical research and furthers Advarra’s objective to connect the clinical trial ecosystem—sponsors, clinical research organizations (CROs) and sites—to make clinical research safer, smarter, and faster. Press release.

Syapse has renewed its strategic collaboration with Pfizer. Real-world data holds tremendous potential for improving the way that cancer care is conceptualized. The Syapse Learning Health Network is a global precision oncology data sharing network aggregating data from across 25 states, 457 hospitals and over 1300 community oncologists. The network enables providers to share and learn from real-world clinical, molecular, treatment, and outcomes data. Press release.

Integrated DNA Technologies (IDT) has acquired Swift Biosciences, a pioneer in the development of Next-Generation Sequencing (NGS) library preparation genomics kits for academic, translational, and clinical research. IDT is a leader in developing and manufacturing nucleic acid products for academic and commercial research, agriculture, medical diagnostics, pharmaceutical development, and synthetic biology. Swift develops and commercializes NGS Library Prep Kits that maximize data output, provide comprehensive coverage, and reduce sequencing costs. Swift associates and products will transition into IDT while continuing to operate from its existing facilities in Ann Arbor, Michigan. Financial terms of the transaction were not disclosed. Press release.