Enabling Trial Collaboration in the Cloud

Execute a 1-Step, 2-Step, or 3-Step Workflow

Authorized users can select which workflows are available within a data room and select the workflow type on a per-document basis.

Manage a workflow, without acting as a reviewer / approver

Workflow Managers (WM) can choose to act in a purely administrative role and select another user as the Final Approver.

Easily Accessible Room- and Domain-Level Settings

Administrators and Managers can easily configure specific components of their domain and data room from the front-end.

Enhanced Security

Configure security settings to help ensure 21 CFR Part 11 compliance including account locking settings, a log-out timer, and password expiration settings.

Store, Modify, and Export Templates

Authorized users can manage document templates within the Documents module so that they are held in a central, easily accessible repository.

Transcripts

With the "My Transcript" feature, GlobalLearn users have a consolidated view of their complete training history, including reported external training outside of GlobalLearn. The My Transcript page also provides users with 24/7 access to their certifications and licenses.

Visual Dashboards

Visual dashboards help users quickly identify important learning insights if you are a learner and a single view of compliance assurance that can let you know exactly where your team stands with the training of your staff if you are a manager. The combination of this provides at-a-glance insight for quick, actionable and effective decision-making.

Live Training Management and Tracking

TI GlobalLearn 1.1 has the capability to track and manage live, in-person and virtual training courses for blended learning. The Live Training feature allows trainers to keep track of attendance from any live training in one central location. This feature allows GlobalLearn customers to further reduce the administrative tasks related to live training.

Assigning Curricula

Rather than enrolling staff in one course at a time, assign an entire collection of training specific to their defined training group. Designate due dates for each course (with training completion reminders) so learners move progressively through their training and have it completed in an appropriate time-frame.

System Generated Questions

Users will have the ability to create forms based on form templates for site feasibility, monitoring report, and rater questionnaire. These templates can be configured to your organization's needs and are easy to access and reuse for future questionnaires.

Submit Responses

Users can now submit responses on behalf of the submitter. This feature helps capture offline investigator responses communicated to the sponsor/CRO (publisher or manager) so they can simply be inputted into the system to save time. The system maintains an audit trail audit trail for submitted responses and auto generates email notifications to the investigator detailing the response submitted.

Edit Submitted Responses

Sponsors/CROs (publishers or managers) can edit and update Investigator response submissions. This new feature enables users to update individual responses as well as allow mass update responses in a single work stream. The system maintains an audit trail audit trail for updates and auto generates email notifications to theiInvestigator detailing the updates.

New Question Type

When adding a new question to a survey, a 'matrix of radio buttons' in the question type section helps users to create questions with multiple answers to a single question. Additionally, the choice of answers provided can be ranked for easy scoring of the submitted responses.

Filter Contacts

Filter contacts by name, role, organization, phone, and email. This feature can be used with the search option, making it extremely convenient to find contact details in an extensive list. The system captures all 'form types' sent to all contacts for easy access in future.

Learn more about our feasibility process

Certification of Documents

myTI makes certifying document copies fast, easy and secure by enabling CRAs to use a biometric ID (Touch/Face ID) or password as an E- Signature before submitting documents to the eTMF. This approach is fully in line with the Framework for the Destruction of Paper and in compliance with 21 CFR Part 11.

Offline Mode

CRAs working in a location with limited wifi or cell service can still use myTI to capture documents with the new Offline Mode enhancement.

Geolocation & Site Map View

CRAs can now easily view their proximity to all of the sites in the study with the ability to select sites from a Site Map to get directions to the site's location.

Favorite Sites

With the ability to select specific site as Favorite Sites, CRAs can personalize their myTI application to focus on those sites and site-specific documents most relevant to their day-to-day activity.

Search for Study/Room and Site

With the new search enhancement, CRAs can now use myTI to search for a specific study/eTMF room or site to quickly navigate within the eTMF.

Brightness, Contrast and Flash

While myTI already had automatic features to ensure document quality, myTI 1.1 adds some additional features to give CRAs more control over the image quality with the ability to turn on the device cameras flash and the options to adjust image contrast and brightness.

Zoom and Document Preview

To provide even more control of document image quality, this release adds an additional zoom feature to allow CRAs to take a closer look at documents in a pre-submission preview prior to publishing to the eTMF.

Learn more about myTI