Integration

Q.1 What types of integrations are provided for multiple customers with Veeva platforms and other systems?

Answer:

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, SimpleTrials CTMS, LedgerRun Payments, DocuSign, Adobe Sign, and Single Sign-On with multiple providers like Okta, SAML, and OAuth 2.0.

Q.2 What are some challenges faced during the implementation of Veeva integrations?

Answer:

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.

Q.3 Does Trial Interactive have an Application Programmer's Interface (API)?

Answer: 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.

Q.4 What is the plan for Trial Interactive interoperability with other Document Management or TMF solutions?

Answer: 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.

Q.5 How is SSO supported by Trial Interactive?

Answer: 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 (current version of underlying protocol used to negotiate an SSO sessions between two endpoints) for dedicated clients. 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 (see Option2xxxx.PPT attached). Allows client to have more control of the SSO integration and provides a means for future client-specific customizations as needed. Also, this approach eliminates a single point of failure for our Okta integrations.
  • Should a dedicated client insist on implementing the Okta Certified Network version of the TI application, we can support that as well. But, should push for option ‘b’ above.
  • We do not yet support policy, group or room assignments via SSO at this time (i.e. when account is created in TI via SSO, we can’t automatically, via SSO messaging, assign the user a role, group or even a study room. That all has to be done manually until we design and build the additional functionality.

Q.6 What integrations are supported?

Answer: 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.

Q.7 Can Trial Interactive integrate with any Regulatory Submissions software?

Answer: The submissions company Extedo currently has plans to release a connector in Q2 2018. This will allow their software, eCTDExpress, to integrate and include documents stored in Trial Interactive directly in regulatory submissions to the FDA, EMA, and most other global agencies.

Q.8 Does TI have any established connections? Is the interface adaptable for connecting with any system using the same protocol? Does TI use SOAP, REST API, or another method? Are there any API restrictions? Can customers access the full set of data, metadata, and content through published and documented APIs?

Answer: Yes. We can connect to any API interfaces, SFTP Dropbox, batch file upload, or similar ESB interconnect utilizing our connector platform. All our APIs are RESTful, and we use JSON for all data points. For a secure Dropbox, we can also intake CSV.

Q.9 How are integrations shielded from changes to the structure of the data repository?

Answer: All of our integrations connect through our Enterprise Service Bus, which requires a standard JSON packet that can support additional data points for each record type as needed. In addition, our TI Connector framework leverages GraphQL to ensure the support of variable data models in the endpoint API.

Q.10 Explain how TI merges data elements based on metadata?

Answer: Our connector framework mirrors the endpoint API in its data model and translates data elements to the TI ESB data model using GraphQL, which supports 1 to 1, 1-to-many, and many-to-many relations.

Q.11 How do you abstract the solution interfaces from the data model?

Answer: We use GraphQL to help us with this abstraction.

Q.12 What EDC and ePRO systems does Trial Interactive currently integrate with?

Answer: 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

Q.13 What types of data can be integrated between EDC/ePRO and CTMS/eTMF systems?

Answer: 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.

Q.14 How does the integration setup and configuration process work?

Answer: The integration process is streamlined and typically includes the following steps:

  1. Requirements gathering via a questionnaire.
  2. Discovery session to map desired data fields and functional expectations.
  3. Access to client test and production environments.
  4. Configuration of Connector endpoints based on client needs.
  5. Validation using a checklist and internal testing in staging.
  6. Deployment to production after successful validation.

  7. Establishment of ongoing support contacts and monitoring.

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

Q.15 How are support and monitoring managed post-deployment?

Answer: Once deployed, Connectors are actively monitored by TI’s support team. Dedicated communication channels (e.g., chat groups or direct contacts) are set up for real-time issue handling. Additionally, TI coordinates with vendor teams to stay ahead of any changes that may impact integration.