General Product FAQs
Following are some general product FAQs:
1. Does Trial Interactive support PDF Portfolios?
Answer:
Portfolio PDFs can only be handled by Adobe Acrobat, as Portfolio PDFs are a proprietary Adobe format and cannot be supported by other applications such as the TI Viewer or Google Chrome’s PDF Viewer. To view these PDFs, our suggestion is to download these types of PDF files and then open them directly in Adobe Reader.
2. Does TI have the ability to take existing TMF folders and documents and drag them into TI.
Answer:
Yes, we can support a mass import of existing documents.
Procedure:
1. Zip the folder structure and documents
2. Bulk upload with the option to unzip the file chosen
Also, on the chrome browser, this can be accomplished by drag-and-drop of a root directory from the machine into the bulk upload window (this is not supported in other browsers).
Please note that this will not carry over metadata from other systems.
3. Does Trial Interactive have a data processing agreement with Amazon Web Services, specifically for GDPR?
Answer:
Trial Interactive leverages AWS for all data processing and storage. As such, TI falls under AWS’ data processing agreement for the purposes of GDPR.
This can be accessed on the Amazon web site here: https://aws.amazon.com/blogs/security/aws-gdpr-data-processing-addendum/.
The specific document may be accessed here: https://d1.awsstatic.com/legal/aws-gdpr/AWS_GDPR_DPA.pdf.
The ISO 27001 certification may be accessed here: https://aws.amazon.com/compliance/iso-27001-faqs/
4. Does Trial Interactive have a way to connect to other content management or document management systems?
Answer: Trial Interactive’s Content Connector is a generic connector that supports multiple content repositories, including Veeva, Documentum, Alfresco, CMIS, and others. Our TI Content Connector is useful for synchronizing your Regulatory, Quality, or Clinical content systems with TI for eTMF. It is a validated application that can be used to connect to a 3rd party system. Because some systems are competitors of ours, they may not certify our TI Content Connector, which is to be expected. However, we have validated it, and we will certify it as a part of any content integration we complete on behalf of our customers.
5. What is the typical turnaround time for a client request for SOC1 and SOC2 reports? Also, will the vendor retain the ultimate responsibility to resolve any SOC1/SOC2 issues or does the vendor expect to work directly with the hosting provider?
Answer: SOC documentation will be provided through a virtual Audit room or in-person only. The SOC3 summary is always available directly from the hosting provider or vendor. As vendor we take ultimate responsibility for all hosting issues, we are providing our software as a service, and provide hosting as part of that service.
6. Should an upgrade cause unexpected issues that do not impact all vendors or customers but does impact one client specifically due to a unique setup e.g. a business process/workflow, what is the typical resolution approach?
Answer: After every upgrade, for 2 weeks afterwards we handle all incidents reported through our hypercare channel, ensuring that we are prioritizing issues in a responsive way. The priorities defined in our MSLA determine the service level targets in terms of timeframe, but we also define incident urgency based on Hypercare status and other attributes, thus ensuring that upgrade issues are handled more efficiently. Finally, a technical project manager is normally assigned to handle the upgrade and stay on as a contact point for 2 weeks afterward.
7. Does TI have a fully functional CTMS system that has been deployed at other client locations ? If no, is there one in consideration and when will that be available for production release?
Answer: We are currently developing a CTMS system that is scheduled to be available in 2020. Any new customers who are interested may participate in our Customer Engagement Programs, specifically a focus group for the CTMS, to ensure we are getting appropriate feedback and involving interested parties in design reviews and functional prioritization of new products.
8. Does the system have the ability to search document contents in addition to being able to search document names and associated metadata?
Answer: Yes. If OCR is enabled, the Search option can search document contents.
9. Concerning the system’s machine e-learning abilities, what if someone repeatedly misidentifies a document resulting in an incorrect training of the AI? How do we systematically un-train the AI on the faulty identification?
Answer: Once the document is corrected, the AI is 'untrained' automatically. Also, the AI is looking at multiple examples. If there are sufficient examples, a small number of misidentified documents would not have a significant impact on the model.
10. What model of validation does Trial Interactive follow?
Answer: Trial Interactive follows GAMP 5 for all validation activities.
11. How do I enable the Machine Translation Function in TI?
Answer:
Optical Character Recognition (OCR) is specific to language and character set. OCR must be enabled by our Service Desk prior to utilizing the Machine Translation feature in a room so that the correct character sets are enabled in the room. Machine Translation is specific to language and API. Many times the specific APIs must be enabled by the Service Desk.
12. What’s the maximum size file that can be directly uploaded into Trial Interactive?
Answer: In 10.1, you can load a file that is up to 2 Gigabytes into TI. Prior to 10.1, the maximum size allowed was 500MB.
13. What’s the maximum size file allowed that can be emailed into Trial Interactive?
Answer: As of TI 10, file attachments of up to 120MB are supported in emails sent to TI. One point of caution is that the sending email server will often have limitations set at < 100MB, most often 20 or 30 MB, which will prevent the file from being sent successfully. If this occurs, Trial Interactive Solution Engineers can work with your IT department to increase the email size limitations and support the full 120MB attachment size.
14. I have a video. What video formats are supported through Trial Interactive?
Answer: In Trial Interactive you can post videos and play them through the TI Viewer. The TI Viewer supports MP4, MOV, AVI, MPG and similar formats.
15. What version of the Reference Model does TI support?
Answer: TI is flexible enough to support multiple structures for document storage. While we do recommend that our clients utilize the most recent version of the Reference Model, we continue to support older versions regardless of system upgrades.
16. What is the largest file size that can be uploaded to TI?
Answer: As of TI 10.1, the Bulk Upload feature can handle files up to 2 GB. Also as of TI 10.1, one can email files to TI that are up to 120MB. Finally, by uploading via sFTP or physical drive, TI can store and provide access to files that are up to 200GB in size.
17. What technology does Trial Interactive use for its Collaborative Edit feature? Does it work just like MSOffice™ or Microsoft Office365™?
Answer: There are several online editors that allow the modification and editing of native Microsoft Office formats, specifically MS Word, MS PowerPoint, and MS Excel. While nothing that works as a thin-client, no-install editor will be quite as functional as the native Microsoft Application, several products come close, including OnlyOffice, OpenOffice, and MS Office Online / SharePoint. Trial Interactive uses OnlyOffice™ for our Collaborative Edit feature. OnlyOffice allows for the online collaboration of native MSWord®, MSPowerPoint®, and MSExcel® documents. OnlyOffice is continually improving their product, and has actually overtaken OpenOffice as the #1 non-native online MSOffice editor, comparing quite favorably to MS Office365.