Integration

The integrations include both embedded and API-based solutions, such as the TPT Global Link Translations Veeva Plug-in (embedded), Content Connector for Veeva RIMs, eClinical, and Veeva Commercial (API integration), and various other API integrations for systems like Medidata Rave EDC, Merative Zelta EDC, DSG EDC, CluePoints RBQM, Simple Trials CTMS, LedgerRun Payments, DocuSign, Adobe Sign, and Single Sign-On with multiple providers like Okta, SAML, and OAuth 2.0.

Some challenges include project schedule management, ensuring the technical and mapping teams meet deadlines for validation team availability, sandbox connectivity issues, and pricing related to sandbox and API throughput. Additionally, configuration changes must be handled carefully to avoid breaking the integration, and sandbox configurations need to match staging and production environments. Monitoring and logging are essential, and validation is best managed by the vendor with customer oversight to avoid schedule delays due to differences in validation processes.

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.

Trial Interactive supports interoperability through CMIS, a standard format that is supported by Documentum, OpenText, Alfresco, and other vendors. Customers have also asked for a Veeva Connector.

SSO is supported via SAML 2.0 and is currently available on all dedicated client instances. Key details include:

• SSO is not supported on TI eTMF Multi-Tenant until TI v10.x
• TI supports SAML 2.0 for dedicated clients and will be extended to MT clients in TI v10.x
• Trial Interactive is listed as part of the Okta Integration Network
• Intention is to have the Okta Integration Network version of the TI application used only by multi-Tenant clients
• Dedicated clients will be asked to create an internal Okta TI application within their Okta account to provide greater control and enable future client-specific customizations
• If a dedicated client insists on implementing the Okta Certified Network version of the TI application, this can also be supported
• Policy, group, or room assignments via SSO are not currently supported and must be managed manually

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: Integrates TMF and CTMS for seamless data flow and reduced duplication.
• Learning Management System (LMS) Integration: Enables training records to be indexed automatically in the eTMF.
• Electronic Investigator Site File (eISF) Integration: Facilitates remote site monitoring and document visibility.

The submissions company Extedo has plans to release a connector that will allow their software, eCTDExpress, to integrate and include documents stored in Trial Interactive directly in regulatory submissions to global agencies.

Yes. TI can connect to API interfaces, SFTP, secure Dropbox, batch file uploads, or similar ESB interconnects utilizing the connector platform. All APIs are RESTful and use JSON for data exchange. CSV intake is also supported for secure Dropbox workflows.

All integrations connect through the Enterprise Service Bus using standard JSON packets. The TI Connector framework leverages GraphQL to support variable data models in endpoint APIs.

The connector framework mirrors the endpoint API data model and translates data elements to the TI ESB data model using GraphQL, supporting one-to-one, one-to-many, and many-to-many relationships.

GraphQL is used to support interface abstraction.

Trial Interactive supports integrations with a wide range of EDC, ePRO, IRT, CTMS, 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

The integration framework supports a wide range of data objects, including:

• 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 custom fields can be configured as needed.

The process typically includes:

1. Requirements gathering via questionnaire
2. Discovery and data mapping session
3. Access to client test and production environments
4. Connector configuration
5. Validation and internal testing
6. Production deployment
7. Ongoing support and monitoring

The full process usually spans 4–6 weeks, depending on complexity.

Post-deployment, connectors are actively monitored by TI’s support team. Dedicated communication channels are established for real-time issue handling, and TI coordinates with vendor teams to anticipate and manage changes that may impact integrations.