By Clinical Research News Team  

June 26, 2024 | SAS has expanded its portfolio to include SAS Clinical Acceleration Repository and SAS Data Maker for synthetic data; Seqster and Thread partner to accelerate access to real-world data for patients, researchers, and life science enterprises; Certara unveiled its next-generation CoAuthor regulatory writing software for medical writers; more. 

PacBio, in collaboration with the international Consortium for Long-Read Sequencing (CoLoRS), announced the launch of the first publicly available and free HiFi long-read variant frequency database with global representation. This innovative resource fills a critical void for rare disease researchers, providing access to genetic variants that are not detectable through short-read sequencing methods. By enabling the filtering of common structural variants from long-read sequencing data, this database allows for the identification of rare and novel variants in rare disease cases. The launch of this database better enables researchers to utilize long-read genomic data to advance human health research. Press release. 

PathAI unveiled two novel AI products, PathExplore Immuno-Oncology Profiling (IOP) and IHC Explore1, to empower cancer drug developers and clinical researchers with AI-powered insights. The product pairing provides unprecedented single-cell and spatial resolution of the tumor microenvironment from routine pathology samples to facilitate biomarker discovery and deeper understanding of treatment response for the next generation of cancer therapeutics. PathExplore IOP expedites characterization of immune phenotypes by quantifying tumor infiltrating lymphocytes and their spatial distribution using routine hematoxylin and eosin samples. PathExplore IOP was designed specifically to quantify patterns of immune infiltration characteristic of a strong immune response, and ultimately improved patient survival. Press release. 

SAS has expanded its portfolio to include SAS Clinical Acceleration Repository, a secure, cloud-native data repository with robust audit and administration capabilities. The analytics platform manages clinical research data, integrates with various data sources, improves clinical trial development and accelerates the path to regulatory submission. Benefits include: access to curated research information and health data through a single system of record via an easy-to-use, modern user interface with intuitive dashboards; a production-ready data repository that enables easier and faster data validation; a multi-lingual, open environment to support use of third-party programming languages and tools and data integration from many locations and sources; and more. Press release. 

To further support the data and AI needs for health and clinical research, SAS has also introduced SAS Data Maker. The powerful synthetic data generation capabilities of SAS Data Maker address data privacy and scarcity challenges by generating synthetic tabular data that statistically represents original training data without compromising sensitive patient health information. This enables health care and life sciences companies to innovate faster by combining trusted data augmentation and generation algorithms in one seamless tool. Press release.  

Sapio Sciences announced Sapio Good Manufacturing Practice (GMP) LIMS for laboratories that require unparalleled flexibility to meet manufacturing compliance standards. The new Sapio GMP LIMS solution addresses industry applications in biotechnology, pharmaceutical, clinical research and diagnostics, food and beverage, chemical, and environmental testing. The three key elements include: Sapio QC LIMS, which streamlines material and product management with configurable dashboards, drug product registration, and batch creation; Sapio Environmental Monitoring Programs, which enhances site, equipment, and storage management by tracking and organizing manufacturing sites, equipment details, and hierarchical storage units; and Sapio Stability Management, which streamlines the setup and execution of stability studies. Press release.

Salesforce announced the general availability of Life Sciences Cloud, a platform for pharmaceutical and medical technology organizations to help personalize patient and healthcare professional (HCP) engagement and streamline clinical operations with data, automation, and trusted AI. Some features include: participant recruitment and enrollment, patient benefits verification, patient program outcome management, and more. Press release. 

Certara unveiled its next-generation CoAuthor regulatory writing software. CoAuthor is an advanced writing platform designed for medical writers. It combines generative AI, document templates, Microsoft Word integration, and structured content authoring tools. CoAuthor accelerates the creation of regulatory documents while maintaining a “human in the loop” approach to the use of generative AI. With CoAuthor, medical writers can streamline the document drafting process, allowing more time for content curation, collaboration, and quality control. Fully integrated with Microsoft Word, CoAuthor enables writing teams to use familiar tools, systems, and processes while ensuring consistency and quality. Press release.   

NTT announces a new method to easily visualize the skill of patients’ hands and feet, which was previously difficult to quantify, by examining the cyclical motion of a smartphone for a short period of time. By using this method to evaluate the movement variability of children and the elderly, it became clear that skill changes with age, and it became possible to evaluate one's skill level relative to individuals of the same age. In addition, forced use of the right hand affected the relative skill of the left and right hands. Surprisingly, this forced correction affected the relative skill between the left and right feet as well. The development of this research is expected to contribute to the visualization of the recovery process through exercise rehabilitation in the medical and nursing fields, as well as to quantify the effects of training during sports activities. Press release. 

QHP Capital, an investor in technology and services companies in the life sciences and healthcare sectors, has announced its sale of Pro-ficiency, a leader in providing tech-enabled training and compliance solutions for clinical trial investigators and site staff, to Simulations Plus, a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy. Press release. 

Banook Group announced the acquisitions of Keosys, a specialist in central imaging, and B.Research, an eCOA platform based in Australia, to strengthen the Group’s offering and footprint. By acquiring Keosys and B.Research, the Banook Group has become a leading technological service provider of clinical trials, with close to 120 employees worldwide and a direct presence in Europe (France, Germany, UK, Italy), North America (USA, Canada) and Asia-Pacific (Australia). The Group is now a key partner for world-renowned pharmaceutical laboratories, biotechnology companies, and Contract Research Organizations. Financial terms were not disclosed. Press release. 

SEQSTER announced a strategic partnership with Thread to accelerate access to real-world data for patients, researchers, and life science enterprises. This partnership integrates primary data captured through Thread’s platform with instant access to secondary data from SEQSTER to expand the volume of participant data captured in a clinical research study. More combined data means an improved ability to determine the impact of new medicines, ultimately accelerating drug development. The partnership will also leverage Thread’s proprietary patient listening technology, ensuring that research studies with real-world data collection are designed with direct feedback from patients. Press release. 

PicnicHealth launched its Pulse product to enable high-quality, low-burden research for life sciences companies and patients. Pulse goes directly to consented patients, accesses their longitudinal medical record, and captures study data through a single, adaptable platform. By cutting through many inefficient layers and systems that burden traditional observational research, Pulse helps life science companies meet study endpoints faster and with full transparency. Sponsors can continuously monitor study progress while patients can engage with the study directly and have ongoing access to their complete medical history. Press release.   

Genialis announced a new partnership with the Pancreatic Cancer Action Network (PanCAN) to expand the validation of the Genialis krasID biomarker in the pancreatic cancer histology. Genialis krasID is a new artificial intelligence classifier that accurately predicts response and clinical benefit to KRAS inhibitors across preclinical, clinical, and real-world settings. Press release. 

The Leukemia & Lymphoma Society (LLS) and Tasso announced a collaboration to accelerate blood cancer research. The relationship will combine Tasso’s signature capillary blood collection technology with LLS’ research and focus on patient advocacy, with the goal of improving the oncology patient experience. Frequent clinic visits and venipuncture blood draws are a burden on patients with leukemia, lymphoma, and other blood cell disorders. The effort of traveling to a distant clinic site for monitoring can be difficult for an ill patient, while in-person visits can present dangers for immunocompromised individuals. To reduce the burden on blood cancer patients, LLS and Tasso are collaborating on a clinical trial evaluating a new patient-centric strategy for collecting critical Complete Blood Count using the Tasso device in blood cancer patients with low blood counts. Press release. 

Medable has partnered with industry leader Masimo to bring best-in-class medical-grade wearable devices to clinical research. Medable has integrated Masimo’s MightySat Rx pulse oximeter into its evidence-generation platform for eight big-pharma-sponsored clinical trials spanning 25 countries including over 3,000 patients across two oncology indications: lung and breast cancer. The device integration eliminates significant travel burdens from often very sick patients while empowering them to participate in potentially lifesaving clinical trials. With this partnership, Medable also enables both subjective data capture—via humans through Medable’s eCOA+ solution—and objective data capture via Masimo’s connected sensors for multifaceted, deeper data analysis in trials. Press release. 

Precision for Medicine has acquired Algorics. The addition of Algorics brings two innovative clinical technologies. The first one is MetaVate, a powerful metadata transformation engine that facilitates efficient and consistent data conversion to meet Clinical Data Interchange Standards Consortium standards and expedite submission readiness. The second technology, Clarity, is a platform for clinical intelligence, risk-based monitoring, and study performance management that centralizes trial data across various sources involved in today's complex trials. The acquisition further bolsters Precision for Medicine's reach in the Asia-Pacific region, as well as enhances Precision's global capabilities in clinical data management, biostatistics, and programming. Press release. 

IQVIA has released its Participant Payments solution, which is intended to address the challenges of managing participant payments in clinical trials. As clinical trials grow in scale and complexity, the need for an efficient, secure, and globally compliant payment solution becomes increasingly critical. Some of the Participant Payments solution’s services include: global payment capabilities, which supports payments in over 180 countries, provides multiple payment options, including virtual debit cards, as well as ensuring participants receive their payments in local currency; real-time payments, which means participants won’t have to wait long periods for their compensation; automated data processing, which allows the platform to seamlessly integrate with existing systems, automating data processing, and reducing administrative workload for sites; and more. Blog post.