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Medidata Solutions’ (NASDAQ: MDSO) introduced the Medidata Clinical Cloud™ Study, which brings the industry-leading benefits of Medidata’s cloud-based platform to single studies as an easy-to-acquire, ready-in-weeks option. It aims to provide unified planning, setup and execution of a clinical trial.
BioClinica®, Inc., a global provider of clinical trial management solutions, announced the introduction of StudyView™, a clinical trials portal and reporting hub that dramatically increases clinical trialsoperational visibility. StudyView provides one convenient tool to access multiple eClinical applications, as well as analyze and report data across studies. StudyView is fully integrated with BioClinica’s product suite and is 21 CFR Part 11 compliant.
BBK Worldwide has launched a new online tool that leverages Google virtual tours for the benefit of patient engagement. The product features 360-degree imaging that provides a virtual tour of the locations where a clinical research study is being conducted. The tool offers potential study participants the opportunity to tour the office space in advance—helping to set expectations and lessen any concerns they may have about participating in a clinical research study.
PAREXEL International Corporation announced the launch of PAREXEL Functional Services within the company's Clinical Research Services business segment. The unit was created to provide solutions for customers interested in outsourcing particular functions rather than full development programs in the clinical development process. It will provide clinical operations, data management, biostatistics, and medical writing, among other service. The services may be offered through a range of engagement models including insourcing/staffing, fully functional outsourcing, as well as customized solutions. Functional sourcing may form the basis of a strategic partnership or may be part of a hybrid partnership model that includes both functional and programmatic outsourcing.
The WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for human research, announced that it has partnered with UL Quality, Compliance and Learning (formerly EduNeering), a leader in technology-driven compliance learning solutions to bring educational opportunities to clinical research professionals. WCG Academy will provide industry, investigators, and other researchers a unique platform with focused, high-value education that is easily tracked across multiple studies. Using UL’s cloud-based platform, ComplianceWire®, WCG Academy will provide clients effective online learning solutions aligned with their needs and with specific study protocols and requirements.
Datatrial announced that the eClinical solutions company is the first Microsoft partner to run a fully validated electronic data capture (EDC) system on Windows Azure. Datatrial will make full use of Windows Azure’s configurability to limit costs for customers using their nowEDC system. The infrastructure-as-a-service (IaaS) approach will give Datatrial control over the setup and configuration of the system, as well as the installation of nowEDC.
Oracle Health Sciences has expanded Oracle Argus Cloud Service to help health sciences organizations meet increasingly stringent regulatory requirements and ensure product safety while optimizing IT return on investment, The expansion enables global monitoring and delivers new insight into adverse events and pharmacovigilance programs.
Merge Healthcare Incorporated, a provider of clinical systems and innovations that seek to transform healthcare, announced the eClinical OS™ Marketplace, extending its clinical trial platform to connect customers with premier industry service providers. The latest release of eClinical OS Marketplace allows customers to request and receive services directly from within study workflows, further enabling study sponsors and CROs to run studies more efficiently. The newest release also introduces Trial Connect, a new mobile alerts and reporting application for accessing study metrics on the go.
Cenduit announced the acquisition of Patient Reminders™, a unique service that allows clients/sponsors to reach patients directly with personalized messages and reminders about crucial aspects of their study—increasing subject compliance and retention in clinical trials—without purchasing special devices. Through this acquisition, Cenduit clients now have the option to access a standalone product or utilize a seamlessly integrated component of their interactive response technology (IRT) system. All IRT data can be integrated into the Patient Reminders platform to complete the full-circuit package of patient participation, including arriving at appointments on time, taking medications on time, returning medications, and drug accountability.
Veeva Systems previewed its new Veeva Vault Investigator Portal. As a companion product to Vault eTMF, Vault Investigator Portal enables fast collection, sharing, and tracking of all investigator content from a single platform. Veeva has specifically designed the new portal to speed study start-up by simplifying the overall trial document management process and providing bi-directional, direct access to the eTMF.
Thomson Reuters previewed Cortellis Clinical Trials Intelligence. The software is designed to optimize clinical trials; decrease time to market; accelerate clinical trial development; and maximize portfolio strategies for professionals in clinical operations and development, R&D benchmarking, R&D strategy, strategic resourcing, precision, and translational medicine at CROs. Capabilities include: access and search information on more than 130,000 trials; access to press releases, literature articles, drug development articles, etc.; full integration with Thomson Reuters industry-leading drug pipeline content; and over a dozen dynamic visualizations that support fact-based decision making and enhance competitive positioning.
Evado Pty LTD, a software company based in Melbourne, Australia, launched a business application (app). The app provides a secure, integrative interface through which users can view, enter, manage, and manipulate complex data across multiple platforms on any mobile or desktop computing device—from anywhere, in any language. Designed for use in all sectors, the app will first be made available to the healthcare industries—and will be particularly useful in streamlining clinical trial processes.
SOA Software, a leading provider of API Management solutions, announced that its Semantics Manager product has been chosen by the Clinical Data Interchange Standards Consortium (CDISC) to power its Shared Health And Clinical Research Electronic (SHARE) Library project. CDISC SHARE will provide a global electronic repository for developing, integrating, and accessing CDISC metadata standards for clinical research in electronic format.
Microsoft Corp. announced the release of third-party qualification guidelines for Microsoft's cloud solutions Windows Azure and Microsoft Office 365, demonstrating that these platforms can address the necessary regulatory requirements for life sciences organizations to maintain compliance in the cloud. Microsoft is the only major combined infrastructure as a service (IaaS), platform as a service (PaaS), and software as a service (SaaS) public cloud provider to undergo an independent review of system documentation against GxP qualification requirements, the set of production and testing practices in FDA-regulated industries, demonstrating documentation against applicable regulations.