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HubMed©Clinical: ArchiMed

Medical device companies are under increasing pressure to deliver rigorous, traceable, and defendable Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER). ArchiMed transforms this traditionally manual and fragile process into a fully guided, structured, and compliant workflow.

HubMed©Clinical, named ArchiMed, is redefining clinical research blending AI-powered automation, adaptive clinical resourcing, and advanced data science. ArchiMed a enables in-house teams in Medical Devices organizations and next-generation CROs, to accelerate clinical trial execution and regulatory submissions. 

The compliance teams from Medical Devices organizations and Contract Research Organizations (CROs) play a critical role in drug development, managing clinical trials, regulatory compliance, and data analysis for pharmaceutical, biotechnology, and medical device companies. However, they face increasing pressure to accelerate timelines, maintain compliance, and optimize resource allocation.

Key Challenges for Compliance teams in Medical Devices Producers and CROs

  • Navigating complex and evolving global regulatory requirements
  • Managing large volumes of clinical and operational data
  • Recruiting and retaining suitable patient populations
  • Coordinating multi-regional trials and global teams
  • Ensuring cost efficiency and operational flexibility

Introducing ArchiMed 

ArchiMed directly addresses these challenges by leveraging artificial intelligence to automate and optimize core compliance processes:

  • Accelerated Research:
    ArchiMed’s intelligent search and summarization tools reduce up to 70% of the time personnel spend on research tasks, instantly surfacing relevant information from internal and external sources.

  • Enhanced Regulatory Compliance:
    Automated monitoring of global regulatory changes and guided workflows ensure teams remain compliant and expedite submission processes.

  • Optimized Knowledge Management:
    AI-powered recommendations organize institutional knowledge, making it easy to access best practices, SOPs, and historical trial data.

  • Intelligent Collaboration and Workflow Automation:
    Seamless integration with existing tools enables real-time collaboration, automated task assignment, and streamlined project execution.

  • Scalable and Secure:
    Cloud-native architecture ensures scalability for organizations of any size, with robust security and compliance features.

By automating routine tasks and surfacing critical insights, ArchiMed empowers either the compliance teams of Sponsors (i.e. Medical Devices manufactures) and CROs to deliver faster, higher-quality results. 

This enables personnel to focus on strategic decision-making and innovation, giving CROs a decisive competitive advantage in the fast-paced world of drug development. The ArchiMed module empowers Compliance teams in MD producers and CROs to deliver faster, higher-quality results by dramatically reducing research time, enhancing regulatory compliance, and optimizing knowledge management. 

By automating routine tasks and surfacing critical insights, ArchiMed enables CRO personnel to focus on strategic decision-making and innovation—giving compliance teams a decisive competitive advantage in the fast-paced world of drug development.

Pricing

Accelerated Research and Decision-Making

ArchiMed module leverages advanced AI algorithms to cut up to 70% of the time CRO personnel spend on research tasks. Whether searching for regulatory guidelines, clinical trial precedents, or patient recruitment strategies, ArchiMed’s intelligent search and summarization tools instantly surface the most relevant, up-to-date information from internal knowledge bases, regulatory databases, and scientific literature.

Enhanced Regulatory Compliance

With automated monitoring of global regulatory changes and AI-driven alerts, the ArchiMed module ensures that CRO teams are always informed about the latest requirements. The platform provides guided workflows for regulatory submissions, reducing errors and expediting approval processes.

Optimized Knowledge Management

The ArchiMed module organizes and contextualizes institutional knowledge, making it easy for teams to access best practices, SOPs, and historical trial data. AI-powered recommendations help personnel quickly find answers, templates, and expert contacts, minimizing time spent searching and maximizing productivity.

Intelligent Collaboration and Workflow Automation

The platform integrates seamlessly with existing tools, enabling real-time collaboration across global teams. Automated task assignment, progress tracking, and document management streamline project execution, freeing up personnel to focus on high-value activities.

Scalable and Secure

HubMed’s cloud-native architecture ensures scalability for CROs of any size, with robust security and compliance features to protect sensitive data and meet industry standards.Write one or two paragraphs describing your product or services. To be successful your content needs to be useful to your readers.

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