Releases FAQ

Question: How often will new releases of Trial Interactive be made available?

Answer: All new Trial Interactive releases deployed to Trial Interactive’ cloud services environment will provide customers instant access to the newest features and fixes. The product is released in both dedicated and multi-tenant versions, depending on the needs of the customer. The multi-tenant versions are released in an iterative, date-bound fashion on a regular basis. The dedicated customers may choose when they wish to apply each release and patch.

• The frequency of all releases is 2 minor and one major release per year.
• The frequency of patches is monthly, unless a major or minor release occurs in the current month.
• Defects selected for specific monthly patches are determined by the 2nd week of the current month, and release notes available by the 3rd week.
• Hot fixes may be created to be applied for critical P1 or P2 incidents for both multi-tenant and dedicated customers.
• Dedicated customers are informed of each major, minor, and patch release so that they can choose when to implement each one.

Question: When a new release of Trial Interactive is ready, how will customers sign up for it?

Answer: Trial Interactive single-tenant customers may request to upgrade at any time after release by speaking to their Account or Project Manager. For multi-tenant customers, all new Trial Interactive releases will be deployed directly to our central servers, providing customers instant access to the newest fixes and features. This deployment approach will allow Trial Interactive to deliver value through the service out to our customers in a more rapid and flexible way.

Question: What kind of internal and external communication will be involved with new releases?

Answer: A regular set of internal and external messages will be sent around each iterative release. This communication will provide customer notification that a new release will be made available on the staging system on a particular date, as well as communicate to them a production release date. This communication will indicate the changes expected in each release, as well as a risk assessment of possible impacts to customers.

Question: How will customers validate new releases of Trial Interactive?

Answer: In order to keep Trial Interactive is a fully validated state, we run every release of Trial Interactive through a complete validation workflow prior to GA in accordance with an SDLC policy, testing procedures, and validation plans. This validation includes standard IQ and OQ tests, as well as Performance tests, user acceptance, and at times a third-party security assessment. A full set installation of operational and performance qualification tests are executed according to an approved validation plan against both Trial Interactive supported versions. Test results are summarized after the validation period and a full set of evidence and traceability are gathered and verified by Quality Assurance.

Once all tests have been successfully completed and reviewed, a Trial Interactive-issued Validation Certification is signed and made available to customers. At that point in time, a new release will be made available to customers in a staging site, along with all formal qualification tests executed by Trial Interactive. This staging environment contains the exact same services as the validation and production environments but will be connected to customer development, UAT, and other non-production instances.

Question: How will defects and emergency issues be repaired on Trial Interactive? How often, and in what form?

Answer: Trial Interactive is being developed with a high level of quality; however, on occasion Trial Interactive or a customer may find a defect. Software will not be released with any known critical or high severity defect. Low to medium severity defects will be repaired with each new release. If a high or critical defect is found, Trial Interactive will assess the customer impact, and Trial Interactive may deploy emergency patches to production without a software prerelease on the staging site. This will be communicated clearly to customers, and a risk assessment will be provided to customers for any defect fixed, and any patch released. Since defects will rarely impact the existing customer process, patches will be treated as any other release but with a low level of validation impacts.

Question: How will new features be made available to customers on Trial Interactive?

Answer: There are two types of new features that need description:

• New features that do not impact the existing customer processes in any way (such as minor cosmetic changes and certain new capabilities) will be made available with each new release according to the process described above.
• Big, impactful features that change the existing customer process however will need to be enabled by each customer individually on their production instance before they will ‘turn on’ for customers and their suppliers. This will allow customers to accept releases and maintain the software in its current validated state without heavy, time-intensive validation periods, and without impacting their current user flow.

Question: Can customers refuse or skip releases of Trial Interactive?

Answer: No. All releases must be ultimately accepted by customers as part of the continual improvement of the single-instance software product. Single-tenant customers may skip releases if necessary.

Question: Will a risk assessment of the impact of new releases be made available for Trial Interactive?

Answer: Yes. All features and defects fixed will come with a formal, documented risk assessment that considers cross-functional code impacts, process impacts, and any specific GxP, ERES, or other CFR compliance impacts. This will be made available in the software release notes.

Question: How will database upgrades be handled in Trial Interactive? How will migrations be handled for Trial Interactive-enabled processes?

Answer: In Trial Interactive, all database upgrades will be done automatically as part of the normal upgrade process. New migrations and processes in will not impact Trial Interactive as the two applications will run in completely separate environments.

Question: Will a product roadmap be made available for Trial Interactive?

Answer: The product roadmap will be made available for the next iterative release of Trial Interactive, to allow customers to prepare and plan for any new features they may wish to enable in their TMF process. This roadmap will be time-boxed, and so certain features may fall out of a release if they are on the ‘gray list’ and not considered to be the highest business priority. This is because Trial Interactive will be developed in an agile fashion, allowing for changes from all stakeholders to better meet the requirements of customers and to maintain an extremely high level of product quality.

Question: How do customers request system changes?

Answer: Trial Interactive engineers are focused on advancing and strengthening Trial Interactive to meet the changing TMF market and evolving customer needs. Product management will constantly monitor how Trial Interactive is being used and listen to our customers' needs to determine new business-relevant features. A percentage of development resources will be reserved to handle incoming customer requests, which will drive enhancements made to Trial Interactive.

Customers may make feature requests to their Project Managers, and upon request may receive a report of the latest status of their feature requests, including target releases, release status, and priority.