Integration FAQs

Can customer include slashes ( / ) in the Site auto-naming rule when configuring CTMS to eTMF integration?

No, slashes in the Site auto-naming rule are not supported and will break the integration. Support for slashes in site names is being removed. Use alternative characters such as hyphens or underscores.

Why aren't some CTMS contacts syncing to eTMF?

Only active contacts are eligible for synchronization to eTMF. If a contact is inactive, it must be temporarily reactivated to allow syncing. After the sync, the contact can be set back to inactive if needed.

Is an email address required for contacts to sync from CTMS to eTMF?

Yes, an email address is currently required for each contact being synced to eTMF (pending full confirmation). Ensure all contacts intended for eTMF include valid email addresses.

In a CTMS-RAVE integration, does the system pull data from RAVE or does RAVE push data to the system?

The system typically receives data from RAVE, but the Medidata EDC Connector can support bi-directional integration depending on business needs.

How soon are data changes in RAVE reflected in the CTMS system?

The connector typically syncs data hourly, but this frequency can be configured to run more or less often as required.

What is the workaround if sites are added in CTMS before the eTMF room is built?

To ensure those sites appear in the eTMF, follow these steps:

  1. In CTMS, update the site status from Selected to Planned.
  2. Wait a few minutes to allow the integration to process.
  3. Switch the site status back to Selected.
  4. Verify that the eTMF reflects the updated site entries.

Does Trial Interactive have an Application Programmer's Interface (API)?

Yes. TI has an API, currently used actively in production by several customers, that enables a close integration with a CTMS. Investigators, Sites, Contacts, Milestones, and Documents may all be passed to and from Trial Interactive.

Through integrations via the TI Integration Gateway, the Trial Interactive system can publish and receive data from other systems through a standard REST-based API. This allows Trial Interactive to receive Investigators, Sites, Study-Sites, Contacts, Milestones, Events, and Documents to and from other clinical systems such as IRB/EC, CTMS, and EDC. Trial Interactive also supports interoperability through a CMIS-compliant REST API, which is a standard for document interoperability that is supported by Documentum, OpenText, Alfresco, and many other vendors. Trial Interactive supports single sign on, authentication, and authorization integrations through a SAML interface, supporting integration partners such as Active Directory and Okta. Finally, the Trial Interactive has available an optional CMS Connector, which is a pub-sub integration component that can facilitate interoperability with both CMIS-compliant and non-standard REST API interfaces.

What integrations are supported?

Trial Interactive offers a range of integrations designed to streamline clinical trial processes by connecting various systems and enhancing workflow efficiency. Key integrations include:

  • Clinical Trial Management System (CTMS) Integration: Integrating the Trial Master File (TMF) with CTMS allows for seamless data flow between document management and study planning systems. This integration reduces duplicate data entry, minimizes errors, and ensures real-time updates, thereby enhancing compliance and collaboration among teams.
  • Learning Management System (LMS) Integration: Trial Interactive's platform supports integration with LMS solutions, enabling efficient training management for site and study personnel. This integration ensures that training records are automatically indexed in the eTMF, reducing administrative burden and maintaining compliance.
  • Electronic Investigator Site File (eISF) Integration: The platform integrates with eISF systems to facilitate remote site monitoring and document management. This integration provides visibility into all documents needed to oversee a clinical trial remotely, enhancing efficiency and reducing the need for site visits.

What EDC and ePRO systems does Trial Interactive currently integrate with?

Trial Interactive supports integrations with a wide range of EDC (Electronic Data Capture), ePRO (electronic Patient-Reported Outcomes), IRT (Interactive Response Technology), CTMS (Clinical Trial Management System), and other clinical systems through standardized TI Connectors.

Currently supported systems include:

  • EDC systems: Medidata Rave, Merative Zelta, iMedNet, DSG
  • IRT systems: EndPoint Clinical
  • CTMS systems: Medidata CTMS, SimpleTrials
  • Other systems: LedgerRun Payments, Advarra IRB/EC, Florence eISF, CluePoints RBQM, Veeva Vault RIM

What types of data can be integrated between EDC/ePRO and CTMS/eTMF systems?

Trial Interactive’s integration framework supports a wide range of data objects, allowing for robust synchronization between systems. Supported data includes:

  • Study-level: Studies, Study Milestones
  • Site-level: Sites, Site Contacts, Site Milestones, Site Visits, Site Visit Reports
  • Participant-level: Participants, Participant Visits

  • Other: Countries, Country Milestones, Protocol Deviations, Safety Events, Contacts, Action Items

    Additional KPI metrics and data points (e.g., queries, custom fields) can also be configured as needed.