Validation

Q.1 Is myTI validated?

Answer: Yes, it is validated.

Q.2 How can a multi-tenant customer ensure that Trial Interactive remains in a validated state, especially during new releases, without having a separate UAT system for pre-release customer validation?

Answer: 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 TransPerfect’s internal validation and cost savings.

If a customer would like the ability to have a dedicated UAT environment (known as 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 contains impact assessments of every new feature and fix.

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

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

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

• TransPerfect will introduce new features disabled by default during upgrade.

• Utilize a ‘UAT room’ within the Multitenant instance which can be leveraged to perform UAT post-upgrade with new features enabled.

Q.3 Does Trial Interactive offer any support for validation?

Answer: 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 as a default. The Dedicated Instance Clients do not share the same hardware, except the mail server infrastructure. The MTI offering is meant as a way to reduce infrastructure costs for TransPerfect and the client. However, the MTI offering does then prohibit clients from declining or delaying releases. Dedicated Instance clients do have full control if they would like to upgrade or when (TI recommends staying on the last two major releases, though).

Trial Interactives approach to Validation is to internally validate us Out of the Box (OOTB) configuration of the system for each type of product release (Major, Minor, Patch). Clients can review TransPerfect’s internal Validation Package (typically done during a qualification audit), and determine if our level of validation meets their expectations. Clients who wish to perform any additional validation/UAT may do so either via their internal process, or they may leverage Trial Interactive’s Validation Services.

Dedicated Instance Clients can perform UAT on a Client-specific Staging environment, and once successfully executed, deploy to Production. MTI Clients, however, do not have access to a client-specific Staging environment. While we grant access to a Pre-Release environment, it is not configured per Client specifications and is only intended for Demo or evaluation purposes. MTI and Dedicated Instance Clients are given advanced notice of the upcoming upgrades via Pre-Release Notes. MTI Clients must wait to validate their intended use of the system post-Upgrade. The impact should be minimal as Features are rolled out and disabled by default.