CTMS FAQ

Question: What about unblinded data in your CTMS? Does the CTMS provide a way to ‘protect’ certain roles from seeing unblinded subject data?

Answer:We do not capture any data within CTMS that would allow for the unblinding of a blinded individual. Blinded data is related to the drug dosing and treatment assignment for a subject, we don’t capture that level of data for a subject within CTMS so we are unable to even push it to the visit reports. We strictly capture the basic subject-related metadata for subject identification purposes (e.g. subject ID, enrollment ID, et.) as well as what ICF that subject signed and when they had a visit, nothing more.

Question: What is the offering? Please describe Trial Interactive CTMS?

Answer: Clinical Trial Management System (CTMS) is a secure, cloud-based solution that enables the collection and management of trial-related data in a single location. TI CTMS provides the ability for clinical study team members, such as study managers and CRAs to plan, collaborate, and track clinical data with specific attention to monitoring requirements. TI CTMS can help our customers by providing:

  • An integrated real-time view of Clinical Trial data
  • The ability to track and view product, program, study, country, site, organization, contact, subject and subject visit data in real-time
  • The ability to plan study-related activities such as site visits, communications, training, and other key trial Milestones with due dates and responsibility
  • The ability to reduce risk by meeting regulatory compliance
  • The ability to manage trial-related documentation with a built-in Content Management System and integrated eTMF
  • The ability to improve quality through standardized business practices and record-keeping
  • Trial insights through study and portfolio dashboards
  • A streamlined eClinical processes to reduce costs

Question: What are some of the features of the CTMS?

Answer: CTMS contains various levels of Clinical Trial data, providing a centralized location to enter, review, and access this data. Users can view data from a global perspective or in the context of an individual clinical trail or program:

  • Contacts (at a global level)
  • Organizations/Sponsors (at a global level)
  • Programs
  • Products
  • Studies
  • Study Countries
  • Study Sites
  • Study Subjects
  • Site Visits
  • Site Visit related documents
  • Activities/Actions/To-Dos
  • Milestones (Study, Country, Site)
  • Study, country, or site related contacts
  • Study, country, or site related organizations
  • Study team membership
  • Enrollment statistics

Question: What are some of the differentiators of the Trial Interactive CTMS?

Answer: Key standouts within Trial Interactive CTMS:

  • Part of Trial Interactive E-Clinical Platform
  • A configurable SAS offered CTMS, providing each customer with the ability to make their own business process modifications while still utilizing a SAS product
  • Contains in application dashboards
  • Provides a direct integration with Trial Interactive eTMF, reducing the need to create study-related information and allowing for use of CTMS and eTMF dashboards for customers utilizing both the TI CTMS and eTMF products
  • Allows for unique user roles based on individual customer needs
  • Utilizes study team membership to control data visibility

Question: What is the industry background of the CTMS?

Answer: The goal of a Clinical Trial Management System (CTMS) is to provide a centralized location for the study team to manage clinical trial-related data. CTMS provides the ability to maintain and manage trial-related data through the planning stage all the way through trial execution to study closure. Users have the ability to plan, prepare, track, monitor, ensure compliance, and report on collected data. CTMS provides a single source of truth helping to reduce frustration within the team and saving time.

Question: What browsers are supported for Trial Interactive CTMS?

Answer: Trial Interactive will be tested with all major browsers, including Chrome, Firefox, Safari, and Edge.

Question: Will Trial Interactive CTMS work on the iPad or other tablets? Will Trial Interactive CTMS work on the iPhone?

Answer: A future release of myTI will incorporate some of the CTMS functionality (e.g. site visit report authoring). CTMS is presently built upon a user interface framework that is designed to work on many screen sizes, including iPads, tablets, and mobile phone devices such as Android and iPhone. However, each of these must be carefully tested to ensure it will operate correctly with that specific screen size as well as the touch interface.

At this time, the myTI product is specifically designed for the iPhone, for document capture at the site by the CRA.