Healthcare
PRODUCTS
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Proactively manage risks of pharmaceuticals, medical devices and other products with TrackWise Digital. The built-in templates comply with ISO 14971 and ICH Q9 allowing manufacturers to manage risks throughout the entire product lifecycle directly within TrackWise Digital.
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Become compliant with FDA 21 CFR Part 11 and EudraLex Annex 11 software validation
SoftMax® Pro 7.2 GxP Software is the latest, most secure software to achieve full FDA 21 CFR Part 11 and EudraLex Annex 11 compliance with streamlined workflows to ensure data integrity. Every step is optimized to simplify analysis and reporting to support our microplate readers.
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Form+ is a recipe management system designed to eliminate waste, ensure consistent and repeatable batches, and provide full traceability to ensure compliance with regulations. The system provides operator guidance for the weighing and dispensing of ingredients and chemicals according to the defined recipe structure. Build process workflows to ensure perfect batches with easy operator usability.
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Connect your entire operations across internal and external sites
Product Lifecycle Data
Consolidate data for each stage of a drug’s lifecycle in one place.
- Expedite compliance by centralizing product lifecycle data for each stage
- Shorten the time between one stage to the next
- Streamline tech transfer and accelerate to commercial rollout
Enterprise Recipe Management
Optimize enterprise recipe management across environments and sites.
- Create and manage a core set of enterprise-wide templates
- Get access to customizable resources for every stage
- Easily assign your templates and resources to individual sites and teams
External Manufacturing Collaboration
Ditch email and calls for automated communications.
- Grant direct view-only access and batch review options as needed
- Provide customers with a self-service approach to their sponsored batches
- Make real-time, data-driven decisions
Tech Transfer
Quickly and easily move all your master resources and data.
- Securely store batch templates, procedures, materials and equipment classes
- Easily share process knowledge and data through transferable global recipes
- Shift a product ad-hoc from one team to another
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NuGenesis LMS, the analytical electronic laboratory notebook capability of the NuGenesis Lab Management System (LMS), enables labs to document observations, control procedures, exchange information with other software solutions, and easily find and collaborate on scientific results. Additionally, it interacts with the NuGenesis SDMS (data archival) component, Waters Laboratory Acquisition Control Environment (LAC/E) devices, SAP, and Empower.
WHITE PAPERS AND CASE STUDIES
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Choosing An EDC With A Robust API For Digital Therapeutics (DTx) Clinical Trials
This white paper explores the importance of choosing an EDC with an API before starting a clinical trial.
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Connecting Patient-Level Clinical Data To RWD
Discover data linkage: a cutting-edge innovation that unlocks a new frontier of enhanced evidence generation by linking clinical trial data and real world data at the patient level.
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How Service Providers Can Create Momentum In An Established Brand
To promote brand growth, companies must identify which brand components are succeeding and which may be falling short, as well as understand how these dynamics manifest in the larger organization’s successes and failures.
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Life-Saving Treatments Reach Patients Faster
Follow LivaNova's journey as they search for a solution to simplify and streamline trial initiation and management processes to expedite the delivery of life-saving devices.
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Pharma Manufacturing: Top 10 Pitfalls To Avoid
Pharmaceutical manufacturers face constant challenges and pitfalls common to the industry, but how can you avoid and overcome them to mitigate risk across the board?
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Operational Considerations For EU Clinical Trial Readiness & Execution
Gain a comprehensive understanding of the Clinical Trial Regulation (EU) 536/2014 (CTR), which has equipped stakeholders to navigate the altered regulatory landscape and prepare for conducting clinical trials in the EU/EEA.
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Solving The EHR-To-EDC Challenge: A Scalable-First Approach
Unearth how industry shifts, technology adoption, and interoperability openness are paving the way for scalable solutions.
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Mobile App And Wearable Integration Collects Longitudinal Data
Get an overview of SISCAPA's utilization of eTechnologies, specifically ePRO, and how their partnership with CDS accurately demonstrates the improvement of data collection and analysis in the biotechnology industry.
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Robust Models For Supporting PV And Medical Information Activity
Learn how outsourcing local pharmacovigilance and medical information activities to an established safety organization can provide high-quality expertise and technology that meets demand.
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How Newark’s Lead Pipe Replacement Program Sparked The Creation Of leadCAST
Learn about how helping Newark digitize their lead pipe replacement program served as the foundation for leadCAST, a cloud-based management system for Lead & Copper Rule program management.
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The State Of Innovation In Europe
Discover the current state of innovation in Europe, from pipeline constitution to emerging drug modalities, R&D alliances to financing trends.
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Reduce Human Error In Healthcare Operations And Medical Equipment Management
Implementing an IoT platform powered by RFID enables clinicians to effectively use medical equipment and reduce human error in healthcare processes to ensure higher quality of care.
NEWS
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CareCloud Welcomes Specialty HomeHealth Provider, Biotic, To The talkEHR Family10/23/2023
CareCloud, Inc. (Nasdaq: CCLD, CCLDP, CCLDO), a leader in healthcare technology solutions for medical practices and health systems nationwide, today announced Biotic, a specialty HomeHealth provider focusing on wound care management, has joined the growing list of healthcare professionals utilizing the comprehensive talkEHR platform.
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MadCap Software Acquires Xyleme To Expand Suite Of Intelligent Content Management Products1/11/2024
MadCap Software, Inc., the leader in multi-channel content authoring, management and publishing, backed by global investment firm Battery Ventures, today announced the acquisition of Xyleme, Inc., a leader in intelligent content management for the development, management, delivery, and syndication of vital proprietary learning and development (L&D) content across the enterprise.
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Samsung, Juniper Networks And Wind River Collaborate To Drive Greater vRAN And Open RAN Efficiencies2/22/2024
Samsung Electronics, Juniper Networks and Wind River have collaborated on a virtual cell site router (vCSR) to allow service providers to operate their networks with end-to-end virtualization. This software-based network ensures more flexibility, agility, sustainability and faster time-to-market (TTM) for the introduction of new services.
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Enhancing The Healthcare Continuum – A Reflection On The Oracle Health Conference12/6/2023
The 2023 Oracle Health Conference unveiled endless opportunities to innovate in healthcare and improve the life’s of patients.