Investigator Initiated Trial Management to Support Strategic Scientific Evidence Generation

Investigator Initiated Trials (IIT) as well as Collaborative Research are a key part of expanding a company’s knowledge of a product. SCIMAX IIT is a powerful, highly configurable, collaboration solution designed to manage the complete lifecycle of both IITs and Collaborative Research. With easy-to-use configurations, the solution can be set up quickly to effectively engage potential investigators and stakeholders, and to manage global and local studies in a compliant and efficient manner.

Measure success using real-time dashboards and views.

Capture Key Performance Indicators (KPIs), strategic objectives, and operational tasks.
View data gaps relative to medical objectives and areas of interest.
Assess project timelines and status via reports and dashboards.
View prebuilt or custom dashboards to gain insights into operational efficiency and impact.
Track KPIs such as number of submissions and time from submission to approval in real-time.

Simple, easy-to-use external interface for investigators.

Allows investigators to submit new studies and provide updates on active studies.
Easily and securely register to submit a new study.
Verify authenticity of registered users based on various credentials such as a National Provider Identifier (NPI) or license number.
Utilize business validation rules to ensure all required data is submitted and updated at the appropriate time reducing the need to request additional information.
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Ensure compliance and provide flexibility when managing studies.

Set-up workflows, milestones, and tasks specific to the type of study, products, regions, and more.
Delete and add milestones and tasks at the study level based on permissions.
Assign workflow with pre-defined milestones and tasks which align with SOPs.
Access full audit trail that captures reviews, decisions, and approval history.

Improve efficiencies through collaboration and automation to reduce timelines and redundancy.

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

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 IIT application.
A user does not need to upload email correspondence or attached documents from a desktop to a project.

Streamline your process by managing the active study throughout the process, efficiently using the investigator portal.

Track subject enrollment, accrual rate, milestones, trial progress, and outcomes.
Capture patient-level milestones such as screening date, enrollment date, and last visit out.
Manage product and fund requests with approval, allocation, and logistics.
Process amendment requests and review collaboratively within SCIMAX IIT.
Reconcile closure activities to ensure all funds were used, final study report or publication was obtained, and study drug was destroyed, if necessary.
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Client-controlled administration allows assigned users to manage and change the system as needed.

Define prerequisites 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

Powerful API integration capabilities
Integrate to your content management system.
Connect to your publication planning system and finance applications.
Integrate with business intelligence and data analytics.

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

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