Comprehensive, Secure, and Efficient Solution to Manage Expanded Access Programs (EAP)

EAP Management

SCIMAX EAP streamlines patient enrollment, ensures regulatory compliance, provides real-time data monitoring, and facilitates collaboration, ultimately improving patient safety, program efficiency, and regulatory adherence while reducing administrative overhead

Key Highlights & Benefits of SCIMAX EAP

Centralized Program Management

EAP management SaaS offers a centralized platform to oversee all aspects of the Expanded Access Program, including patient enrollment, treatment tracking, regulatory compliance, and data management. This centralization improves efficiency and ensures better control over the program

Streamlined Patient Enrollment and Eligibility

The system facilitates secure patient enrollment by verifying eligibility against predefined clinical criteria. This simplifies the process and ensures that only appropriate patients are enrolled in the program, ensuring patient safety and compliance with regulations.

Real-Time Data Monitoring

The platform provides real-time tracking of patient data, including treatment outcomes and adverse events. This allows for faster decision-making and early detection of any safety or efficacy concerns, which can be critical in managing expanded access treatments.

Regulatory Compliance and Reporting

The EAP SaaS ensures compliance with local, national, and international regulatory requirements by maintaining an audit trail, handling required documentation, and generating reports. This reduces the risk of regulatory breaches and helps ensure that all aspects of the program meet regulatory standards

Simplified Communication and Collaboration

The system facilitates communication between various stakeholders, including healthcare providers, pharmaceutical companies, and patients. It enables secure messaging, document sharing, and real-time updates on patient progress, improving collaboration and reducing communication bottlenecks.

Integrated Workflow Automation

With configurable workflows, the SaaS system automates critical tasks such as patient consent management, approval routing, and regulatory submission tracking. This reduces administrative burdens, increases program efficiency, and minimizes human error.

Customizable Access and Role-Based Permissions

The platform allows for customizable access, ensuring that only authorized personnel can access sensitive patient information. Role-based permissions ensure secure handling of data, fostering trust among patients, healthcare providers, and regulatory bodies.

Comprehensive Documentation and Knowledge Management

The system serves as a centralized repository for all program-related documents, including patient records, treatment protocols, regulatory submissions, and communication logs. This makes it easy to access and manage vital information at any stage of the program.

Scalability

The SaaS solution is scalable, allowing pharmaceutical companies to manage multiple EAPs across different regions or therapeutic areas. It can handle an increasing number of patients and trials without compromising performance or functionality.

Scalability and Flexibility

The SCIMAX IIT platform is scalable, adapting to the needs of both small-scale investigator-initiated studies and large, multi-center trials. The flexibility of the system allows it to be customized to fit various trial types and therapeutic areas

Fanatic Support & Fully Managed Platform

The platform offers 24×7 support, easy scalability, certified-ready Integrations, automatic updates, higher security, in-built data privacy controls, performance, reliability, flexible pricing and options etc.

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Why SCIMAX EAP is Better?

SCIMAX EAP is a purpose-built Medical Information Management System, offering Multiple Benefits and Superior Value compared to Legacy Solutions, Custom-Built Apps on a public platform & Cross Functional Horizontal platform-based Medical Inquiry apps.

With continuous updates and compliance features, SCIMAX EAP outperforms other options in meeting the continuously evolving needs of Medical Information needs.

SCIMAX EAP Offer Following Advantages to Clients

  • Faster Time-to-Value

  • Lower Total Cost of Ownership (TCO)

  • Scalability and Flexibility

  • Automatic Updates and Maintenance

  • Enhanced Security and Compliance

  • Focus on Core Competencies

  • Integration Capabilities

  • Customer Support and Expertise

Explore SCIMAX EAP Product Functionality

Patient Enrollment and Eligibility Tracking

  • Securely enroll patients with detailed personal and medical information.
  • Verify patient eligibility based on predefined clinical trial criteria, disease type, stage, and other medical factors.
  • Integrate with existing medical record systems (EHR/EMR) to confirm eligibility and access relevant treatment history.

Comprehensive Patient Monitoring and Real-Time Clinical Data Management

  • Store comprehensive patient medical history, treatment details, and progress reports under the EAP.
  • Monitor patient outcomes, adverse events, and other metrics during treatment.
  • Enable real-time updates to clinical data for faster decision-making.

Centralized Knowledge Repository for EAP Documentation, Guidelines, and Drug Information

  • Centralized knowledge repository housing documentation, drug information, treatment protocols, and research publications.
  • Easy access for medical staff to relevant information.
  • Provides healthcare providers with up-to-date guidelines for using the investigational drug under the EAP.

Real-Time Collaboration and Task Management for Medical and Regulatory Teams

  • Enables real-time collaboration between medical and regulatory teams on patient cases.
  • Supports document sharing, case discussions, and consultations.
  • Facilitates task management by assigning tasks, setting deadlines, and tracking progress.
  • Tracks progress on treatment requests, documentation, and approvals.

Integrated Tools for Data Visualization, Performance Monitoring, and Advanced Analytics

  • Integrated tools for creating high-quality figures, charts, and tables, directly embeddable into PowerPoint and other formats.
  • Customizable, real-time dashboards to monitor grant performance and KPIs.
  • Enables trend analysis and impact measurement for strategic decision-making.
  • Monitors patient data trends (e.g., efficacy, side effects) with real-time report generation.
  • Allows creation of customizable reports for regulatory submissions or internal analysis on treatment outcomes and safety data.
  • Utilizes AI/ML for forecasting demand and identifying patterns in patient responses to drugs.

Latest Resources

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Elevating Medical Information Operations with Cognitive Automation and Generative AI (Recording)

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Launching a Global Medical Information System for a BioPharma Company that specializes in Rare Diseases

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JMP Pharma Group Chooses SciMax Global as Their Medical Information Provider

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Medical Affairs Professional Society Americas
23-26 MARCH 2025, New Orleans, LA

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