Centralize and Simplify the Management of Expanded and Managed Access Programs

Expanded and Managed Access Programs are important for patients with life-threatening conditions. However, there are multiple challenges and obstacles a pharmaceutical company or a contract research organization (CRO) faces during the lifecycle of program. These challenges include defining a program and its eligibility criteria, approval tracking, informed decision making, data management, continuous oversight, program tracking, transition planning, regulatory compliance, and adhering to standard operating procedures (SOP).

SCIMAX EAP is a powerful, highly configurable, collaboration solution designed to manage a single-use or protocol-based Expanded or Managed Access Programs. With user-friendly configuration, the solution can be setup quickly to efficiently qualify patients based on key eligibility criteria and manage program workflows and documentation.

Gain insights into operational efficiency with real-time dashboards and reports that capture Key Performance Indicators (KPIs) and operational task status.

View prebuilt dashboards or create custom dashboards.
Track KPIs such as number of requests and time from submission to decision in real-time.
Assess project timelines, status, and additional drug requests via reports and dashboards.

Simple, easy-to-use external interface for physicians to submit requests and updates.

Easily and securely submit a new request for review and approval.
Verify authenticity of registered users based on various datapoints such as National Provider identifier (NPI) or license number.
Qualify healthcare providers based on submitted credentials and selectively grant access permissions to individual programs.
Notify user when information is required so that data is accurate and complete at submission thus reducing need to request follow-up information.
Define Work Instructions and Help Content to support requestors in submitting different types of requests.
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Ensure compliance and provide flexibility when managing requests.

Setup workflows, milestones, and tasks that meet compliance requirements and are specific to the type of request, product, region, and more.
Delete and add milestones and tasks at the request level based on permissions.
Assign workflows with pre-defined milestones and tasks which align with SOPs.
Access full audit trail which captures reviews, decisions, and approval history.

Improve efficiencies through collaboration and automation to reduce timelines.

Collaboratively review documents with track changes and comments in a single version.
Accept, delegate, decline, and reassign tasks with different permission settings.
Automatically advance through workflows with parallel or sequential reviewing.
Powerful alerts and notifications sent to internal and external users based on established criteria and business rules.

Leverage transparent supply and status tracking to reduce the time it takes to provide potentially life-saving therapy to patients.

Track activities and safety outcomes of individual patients and protocols.
Track submissions and approvals from regulatory bodies and ethics committees.
Manage product approval, requests, allocation, and logistics.
Manage and track investigational product return or product destruction.

Capture all email correspondence related to a project to further reduce study timelines.

Manage all inbound and outbound email communication between external users and your company directly from the SCIMAX EAP application.
View all email correspondence and attachments in an organized and dedicated area of a project.
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Client-controlled administration allows assigned users to manage and change the system as needed.

Define prerequisites and eligibility criteria for registration and submission of requests.
Define workflows and configure forms required for different stages of a program with options to collect documentation related to approvals and amendments.
Add or update custom fields, new email templates, dropdown values, and security policies for user access on demand.
Define work instructions and help content to provide guidance for external user submission of IIT funding requests and for internal user evaluation of such requests.

Connect to data in other solutions to gain additional efficiency and more insight.

Connect drug supply and clinical trial management applications via available API configurable integrations.
Seamlessly integrate with third-party data analytics and business intelligence tools.

If you would like more information or would like to see a demonstration, please send us a request.

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