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Customer Lifecycle

Onboarding & Integration

📄 28 of 33 📅 January 2, 2026 🏷️ v1.1.0

Onboarding & Integration

Category: Customer Lifecycle | Audience: undefined | Page: 28 of 33

Table of Contents

- Create a Tenant/Study

- Ensure Data Isolation

- Manage User Roles

- Follow the Onboarding Checklist

Onboarding & Integration

Welcome to Elixia Health's clinical trial platform! This guide will walk you through the onboarding and integration process, ensuring a smooth and successful implementation of our platform for your clinical trials.

Key Concepts

  • Tenant/Study: A unique space within the platform dedicated to a specific clinical trial.
  • Data Isolation: Ensuring that data from different sponsors and studies remains separate and secure.
  • Integrations: Connecting the platform with other systems like CRMs and EHRs to streamline processes.
  • User Roles: Defining permissions and access levels for different users.

What You Can Do

  • Create and manage tenants/studies
  • Ensure data isolation between sponsors/studies
  • Integrate with various systems
  • Manage user roles and permissions
  • Validate data accuracy
  • Follow the onboarding checklist
  • Meet go-live criteria

How To

Create a Tenant/Study

  1. Log in to the MCT portal and navigate to the "Study" sub-tab.

- Access the main navigation menu and select "Administration" or "Settings"

- Click on the "Study" option to access the study management interface

  1. Click on the "Add New Study" button.

- This will open a new study creation form with multiple sections

  1. Fill in the required information in the Study Details section:

- Study Name: Enter a descriptive name for the clinical trial (e.g., "Phase III Cardiovascular Safety Study")

- Study ID: Enter a unique identifier for the study (e.g., "TRIAL-2026-001")

- Sponsor Name: Select or enter the sponsoring organization

- Principal Investigator: Identify the lead researcher or principal investigator

- Description: Provide a comprehensive description of the study objectives and scope

- Study Protocol: Upload or reference the study protocol document

- Study Start Date: Set the anticipated start date for enrollment

- Study End Date: Set the anticipated end date

- Therapeutic Area: Select the applicable therapeutic area (e.g., Cardiovascular, Oncology, Immunology)

- Study Phase: Select the phase (Phase I, II, III, IV)

- Number of Sites: Specify how many research sites will participate

- Expected Enrollment: Indicate the target number of participants

  1. Configure Study Permissions and Access:

- Assign the Sponsor as the primary account owner

- Define which user roles can access this study

- Set up study-specific notification preferences

- Configure data export and reporting permissions

  1. Click "Save" to create the study.

- A confirmation message will appear upon successful creation

- The study will now be available in the Study list

- An automated notification will be sent to assigned study administrators

- The study ID can now be referenced when onboarding sites and users

Ensure Data Isolation

  • Technical Measures:

- Database Design: The database architecture separates data by sponsor and study at the schema level

- Each sponsor has isolated database schemas to prevent cross-sponsor data access

- Each study within a sponsor maintains separate data partitions

- Primary keys include sponsor ID and study ID to enforce data boundaries

- Table Structures: Include sponsor-specific and study-specific fields

- Sponsor ID column is present in all relevant tables and used in WHERE clauses for queries

- Study ID column isolates data within multi-study sponsors

- Row-level security is implemented at the database level using these identifiers

- Data Encryption:

- Data at rest is encrypted using AES-256 encryption

- Data in transit is encrypted using TLS 1.3

- Encryption keys are managed separately per sponsor to prevent cross-access

  • Procedural Measures:

- Access Control: User roles and permissions enforce data isolation

- Users are assigned roles within specific studies (Study Admin, Study Coordinator, etc.)

- Database queries automatically filter by user's assigned study and sponsor

- API endpoints validate user permissions before returning any data

- Data Segregation: Data is logically separated by sponsor and study

- Study-specific reports only include data from that study

- User dashboards display only data they have permission to access

- Export functions are filtered to prevent unauthorized data access

- Study Documentation: Study-specific documentation is reviewed and approved by sponsors

- Study protocols, consent forms, and SOPs are maintained separately per study

- Version control tracks all document changes with sponsor approval trails

- Access to study documents is restricted based on user roles

- Data Processing Agreements: Agreements are in place for each sponsor

- Defines data ownership, processing rights, and security responsibilities

- Specifies data retention periods and deletion procedures

- Includes audit rights and breach notification procedures

Manage User Roles

  1. Log in to the MCT portal as an Admin user.

- Verify that your account has administrative privileges

- If you are not an admin, contact your organization's system administrator

  1. Navigate to the "User Roles" section:

- Click on the "Security" tab in the main navigation menu

- Click on the "User Roles" hyperlink within the Security tab

- The User Roles management page will display

  1. Select the User and Assign a Role:

- In the "Select User" dropdown list, search for and select the user you wish to assign a role to

- From the "Available Roles" list, choose the desired role based on the user's responsibilities:

- Study Admin: Full control over study configuration, user management, and settings

- Study Coordinator: Can manage patient data, visits, and trial operations

- Data Entry Specialist: Limited access to enter and update specific patient information

- Monitor: Read-only access to view study data and reports

- Site Admin: Manages site-specific users and configurations

- Project Ops: Manages operational aspects across multiple studies

- Viewer: Read-only access to designated reports and dashboards

  1. Configure Role-Specific Permissions:

- Once a role is selected, additional permission options may appear

- Configure study-specific access (select which studies the user can access)

- Enable/disable specific features (reporting, exports, patient management, etc.)

- Set data visibility levels (can they see all sites or just assigned sites)

  1. Click on the right arrow button to add the role to the user's assigned roles list.

- The role will be moved from "Available Roles" to "Assigned Roles"

- Multiple roles can be assigned to a single user if needed

- Role hierarchy is respected (e.g., Admin roles have broader permissions than Coordinator roles)

  1. Review and Configure Additional Settings:

- Study Access: Specify which studies this user can access (if applicable)

- Site Assignment: Assign the user to specific research sites (for site-level roles)

- Effective Date: Set when the role assignment becomes active (optional)

- Expiration Date: Set when the role assignment expires (optional, for temporary assignments)

- Approval Required: Configure if role assignment requires manager approval

  1. Click "Save" to confirm the role assignment.

- A confirmation message will appear indicating the role has been successfully assigned

- The user will receive a notification email about their new role and permissions

- Changes take effect immediately or at the specified effective date

- An audit log entry is created for compliance tracking

  1. Best Practices for Role Management:

- Regularly review user roles quarterly to ensure they match current responsibilities

- Remove roles no longer needed to maintain principle of least privilege

- Document role assignments and business justification

- Use role expiration dates for temporary assignments

- Ensure segregation of duties (e.g., data entry and approval are separate roles)

💡 Tip: Regularly review and update user roles to ensure users have the correct access and permissions.

Follow the Onboarding Checklist

  • Review and confirm project details.
  • Set up and configure the platform.
  • Conduct testing and quality assurance.
  • Review and finalize the implementation plan.
  • Schedule regular maintenance and updates.

Tips & Best Practices

  • Assign roles correctly to ensure users have the necessary permissions.
  • Regularly review and update user roles as needed.
  • Utilize the onboarding checklist to ensure a smooth implementation.
  • Conduct thorough testing to validate data accuracy.

Next Steps

  • Explore the MCT portal and familiarize yourself with the available features.
  • Reach out to the Elixia Health support team for any assistance or questions.
  • Begin setting up your first tenant/study and start your clinical trial journey with us!

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Generated from MCT Knowledge Base • v1.1.0 • January 2, 2026