Validation

Yes, it is validated.

TransPerfect sells Trial Interactive as a Software-as-a-Service (SaaS) system, which means we’re providing the eClinical software and the infrastructure to support that software. To reduce costs for both TransPerfect and our customers, we offer two solutions during the onboarding process for hosting: a Dedicated and a Multitenant instance.

The Enterprise / Dedicated deployment model offers a client greater control over specific system settings and full control over any upgrades. This is achieved by a unique deployment/maintenance of infrastructure, which naturally comes at a higher cost. The Multitenant instance (MTI) limits control over system settings and relinquishes control over any upgrade but reduces deployment/maintenance costs. MTI is generally leveraged by clients due to their comfort with TransPerfect’s internal validation and cost savings.

If a customer would like the ability to have a dedicated UAT environment (known as a Stage environment) or would like the ability to decline upgrades, then a Dedicated Instance must be leveraged for future studies.

If Multi-tenant is used, customers can maintain a validated state and limit risk in the following ways:

• Receive and review Pre-Release Notes several weeks before release, which contain impact assessments of every new feature and fix.

• Evaluate and document any potential risks to the intended use.

• Access a generic Pre-Release environment several weeks before upgrade to assess existing UAT scripts for modifications.

• Review the Validation Package that TransPerfect generates internally for each release and document any potential risks.

• TransPerfect introduces new features disabled by default during upgrades.

• Utilize a UAT room within the Multitenant instance to perform UAT post-upgrade with new features enabled.

Trial Interactive offers two deployment methods for the Trial Interactive system: a Multi-tenant Instance (MTI) or a Dedicated Instance.

The MTI clients are deployed on the same system and share the same hardware. Their data is logically separated through access controls by default. Dedicated Instance clients do not share the same hardware, except for the mail server infrastructure. The MTI offering reduces infrastructure costs for both TransPerfect and the client but prohibits clients from declining or delaying releases. Dedicated Instance clients retain full control over when or whether to upgrade (TI recommends staying on the last two major releases).

Trial Interactive’s approach to validation is to internally validate the out-of-the-box (OOTB) configuration of the system for each product release type (Major, Minor, Patch). Clients can review TransPerfect’s internal Validation Package (typically during a qualification audit) and determine whether the validation level meets their expectations. Clients who require additional validation or UAT may perform it through internal processes or leverage Trial Interactive Validation Services.

Dedicated Instance clients can perform UAT on a client-specific staging environment and, once successfully executed, deploy to Production. MTI clients do not have access to a client-specific staging environment. While access to a Pre-Release environment is provided, it is not configured per client specifications and is intended for demo or evaluation purposes only. MTI and Dedicated Instance clients receive advance notice of upcoming upgrades via Pre-Release Notes. MTI clients validate intended system use post-upgrade, with minimal impact as features are rolled out disabled by default.