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RegDeskRegDesk stands out as the leading RIMS platform enhanced by AI, tailored specifically for Medical Device, Pharmaceutical, and IVD companies. • Our unique Regulatory Intelligence encompasses data from over 120 countries, all presented in a uniform format, and includes timely alerts regarding regulatory updates. • With our AI-driven Application Builder, regulatory affairs teams can efficiently create and submit global applications in a fraction of the usual time. • The Change Assessment feature enables RA teams to evaluate the implications of changes on current products and determine the necessary actions. • Our Distributor Collaboration tool facilitates smooth workflows for communication and document sharing with external partners. • The Standards Management function simplifies the process for RA teams to locate and oversee both international and country-specific standards. • Additionally, our Tracking & Reporting capability empowers teams to monitor regulatory initiatives worldwide, receive notifications for renewals, and quickly compile reports on key performance indicators. To learn more about our offerings, please explore our website.
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EldermarkEnhancing workflow processes, optimizing revenue, advancing business development and marketing, along with improving clinical outcomes, can be achieved effectively. By seamlessly connecting your entire community, you can empower your staff to enhance their performance while gaining a comprehensive overview of your community's financial health. This approach will equip you with proactive insights necessary for streamlining operations and maximizing revenue potential. Centralizing all clinical and business activities onto a single platform will provide you with simplified solutions, economies of scale, and heightened security, essential for delivering top-notch care. Furthermore, you'll gain deeper insights into your performance in relation to financial and occupancy targets, staff safety, and satisfaction levels, enabling you to address the numerous challenges you encounter daily. Ultimately, this integrated strategy will facilitate a more efficient and effective care environment.
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Predict360Predict360, developed by 360factors, serves as a comprehensive risk and compliance management platform designed to streamline workflows and improve reporting for various financial institutions, including banks, credit unions, and insurance companies. This cloud-based SaaS solution consolidates essential components such as regulations, compliance management, risk assessments, controls, key risk indicators (KRIs), audits, policies, and training into one cohesive platform while offering powerful analytics and insights that help clients foresee risks and enhance compliance efforts. If your current Governance, Risk, and Compliance (GRC) system isn't equipped with an effective analytics and business intelligence tool for creating insightful reports for executives and board members, consider Lumify360 from 360factors. This predictive analytics platform can seamlessly integrate with any existing GRC, allowing you to maintain your workflow processes while equipping stakeholders with the timely reports and dashboards they require for informed decision-making. With these advanced tools at your disposal, you'll be better positioned to navigate the complexities of regulatory compliance and risk management.
What is PharmaPendium?
PharmaPendium is a comprehensive resource that provides users with access to a wide range of drug approval documents from the FDA and EMA, covering crucial elements such as pharmacokinetics, pharmacodynamics, and safety assessments. This platform offers valuable insights into drug interactions, adverse effects, and clinical trial outcomes, enabling stakeholders to make informed decisions in both drug development and regulatory submissions. Its extensive database supports researchers and healthcare professionals in evaluating the safety and effectiveness of various medications, thereby playing a critical role in advancing pharmaceutical research and improving patient care. Users can also investigate historical regulatory submissions and utilize previous cases to gain a clearer insight into agency expectations. The user-friendly interface facilitates an easy transition from raw data to engaging visual representations like charts and graphs, enhancing the analysis and interpretation of results. Furthermore, the platform allows users to search for information on adverse events (MedDRA), therapeutic targets, drug indications, and endpoints through standardized data. Result pages effectively link preclinical research with clinical applications, offering a holistic view of the drug development ecosystem. Overall, PharmaPendium not only simplifies the research process but also encourages collaboration and knowledge exchange among professionals in the industry, ultimately contributing to better health outcomes. The array of features offered by this platform makes it an invaluable tool for those involved in the pharmaceutical field.
What is Ennov Pharmacovigilance Suite?
Ennov's Pharmacovigilance Suite provides a robust solution for the collection, management, assessment, and reporting of adverse events across both human and veterinary sectors, all housed within a unified database. The suite features advanced tools for signal detection and data analysis, ensuring compliance with international regulatory requirements. Key elements include optimized case intake and triage functionalities, improved user interfaces for data entry, customizable case input forms, and a wide array of searchable vocabulary lists. It supports multiple reporting formats, facilitating both paper and electronic submissions that adhere to CIOMS guidelines, MedWatch 3500s, and ICH E2B standards (R2 and R3). For signal detection and management, the platform provides comprehensive data querying capabilities, powerful analytical tools, and the ability to calculate important statistical metrics like PRR, ROR, and MGPS. Fully web-based and designed for ease of use, it complies with the standards set forth in 21 CFR Part 11, which ensures data integrity and security. Additionally, its flexible design allows it to cater to organizations of varying sizes, enabling users to adeptly manage the intricate landscape of pharmacovigilance while remaining responsive to evolving industry demands. This adaptability ensures that as organizations grow or change, the system remains a reliable resource throughout their pharmacovigilance journey.
Integrations Supported
Additional information not provided
Integrations Supported
Additional information not provided
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
Elsevier
Date Founded
1880
Company Location
Netherlands
Company Website
www.elsevier.com/products/pharmapendium
Company Facts
Organization Name
Ennov
Date Founded
1999
Company Location
France
Company Website
en.ennov.com/solutions/pharmacovigilance/