Support FAQ

Question: What is the process of how incidents are reported and how Trial Interactive supports sponsors, sites, and CROs?

Answer: Incidents are identified at TransPerfect in a number of different ways – monitoring alerts, customer calls, vendor notifications, or internal observations. Once an incident is encountered it Trial Interactive's main focus is to resolve the issue and provide the customer with the expected service levels. Reported incidents are validated by TransPerfect support resources and a defined set of steps are executed to attempt to quickly resolve the issue. When an incident is severely interrupting service levels the incident is escalated. Any changes required to the production application services environment in order to resolve an incident are handled through the change management process.

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Question: Will TransPerfect employees need a Trial Interactive Account? If so, how do they get one?

Answer: Services, hosting, and support employees will require test accounts for verifications and troubleshooting. These accounts must come from the customer who requires this access in order for support to troubleshoot a specific customer record.

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Question: Is Trial Interactive browser independent? What browsers work best?

Answer: Trial Interactive will be tested with all major browsers, including Chrome, Firefox, Safari, and Internet Explorer 10, 11, and up.

Question: Will Trial Interactive work on the iPad or other tablets? Will Trial Interactive work on the iPhone?

Answer: In a future release. Trial Interactive is presently built upon a user interface framework that is designed to work on many screen sizes, including iPads, tablets, and mobile phone devices such as Android and iPhone. However, each of these must be carefully tested to ensure it will operate correctly with that specific screen size as well as the touch interface.

Question: What documentation will be made available for customers around the support of Trial Interactive?

Answer: Training courses and documentation will be made available to customers that describe common issues and resolutions for customers.

Question: What is the overall SLA (Service Level Agreement) for Trial Interactive?

Answer: Trial Interactive provides for 24/7 email and phone Service Desk support as a backup to internal System Administration and support. The TI Service Desk is multi-lingual to handle global users. Our support staff can also accommodate the roll-out of all system updates, major and minor, pending agreement on the date, time, and process of implementing the updates.

Use and Access

Subject to the terms and conditions of the Agreement, Customer will have access to the Licensed Software and TransPerfect's application server for the purpose of using the Licensed Software for its intended purpose and in accordance with the specifications set forth in any User Documentation relating to the Licensed Software provided by TransPerfect.

Customer will not::

Transmit or share identification or password codes to persons other than authorized users.
Permit the identification or password codes to be cached in proxy servers and accessed by individuals who are not authorized users, or
Permit access to the software through a single identification or password code being made available to multiple users on a network.

Service Desk Support

TransPerfect offers global support for Trial Interactive users: 24 hours per day, 7 days per week, 365 days per year for all Trial Interactive functions. Support includes both email and phone and a range of languages if needed. TransPerfect will provide the level of support contracted by our clients. Users or subcontractors can email help@trialinteractive.com for the most prompt response or call our support. Response times for support are outlined in the table below. TransPerfect Trial interactive maintains a help system that monitors each ticket being opened through a resolution for metrics tracking purposes. The help system can classify types of support needs for clients to allow for review of trends and make recommendations on additional training requirements.

Maintenance Support Services

During the term of the Agreement and provided the customer has paid the applicable Service Desk Support fees set forth herein or in a statement of work, TransPerfect will provide maintenance, telephone support, correction of errors, and upgrades to the Trial Interactive applications as set forth below.

Real-time to customer’s dedicated service desk or personnel in the form of telephone support,
Updated release notes associated with error corrections to the Trial Interactive applications,
Error corrections to the Trial Interactive applications, and
Customer support surveys to allow Customer to assist TransPerfect with the evaluation of their support.

Error Corrections

TransPerfect will use commercial best efforts to provide customers with error corrections within the timeframes set forth in the table below. Customers will provide TransPerfect with documentation of the error or deficiency, and customers will provide the necessary software and data required to reproduce the error or deficiency reported by the customer and all other reasonable support and assistance requested by TransPerfect as necessary to discover the cause or a cure for the reported error or deficiency in the Trial Interactive application.

Service Desk Response Times

TransPerfect's client services representative team has the following traditional Service Desk response times as part of our Support Services. All email requests will be acknowledged within 30 minutes via email notification. HIGH PRIORITY will have an email/phone response within 30 minutes and target resolution within 8 hours with updates every hour. MEDIUM PRIORITY will have an email/phone response within 4 hours and target resolution within 24 hours / 1 business day with updates every 4 hours. LOW PRIORITY will have an email/phone response within 24 hours and target resolution within 15 days. The remaining priorities pertain to service and change requests.

Facilities Security

TransPerfect’s co-located data center facilities are controlled access environments.

Network Infrastructure

The TransPerfect data center facilities will utilize a minimum of two competing fiber-optic telecommunication providers.

Question: What is the Help Desk SLA (Service Level Agreement) for Trial Interactive?

Answer: TransPerfect's client services representative team has the following traditional Service Desk response times as part of our Support Services. All email requests will be acknowledged within 30 minutes via email notification. HIGH PRIORITY will have an email/phone response within 30 minutes and target resolution within 8 hours with updates every hour. MEDIUM PRIORITY will have an email/phone response within 4 hours and target resolution within 24 hours / 1 business day with updates every 4 hours. LOW PRIORITY will have an email/phone response within 24 hours and target resolution within 15 days. The remaining priorities pertain to service and change requests.


Priority Level	Maximum Initial Response Time	Target Resolution and Updates	Description
Priority 3 (LOW)	Within one (1) business day	15-day target with 5-day update	An issue that impairs the performance or functions of the software. There is no loss of data associated with the reported error or deficiency in the Trial Interactive application service and the customer’s business process can continue or work around the reported issue(s) through proper business procedures with no serious impact on service levels. Examples: Redaction Problem, Edit Online issue, Duplicate Documents.
Priority 2 Incident (MEDIUM)	Within four (2) hours	24 hour target with 4 hour updates	An issue that substantially restricts functional operations of the software. The customer business process either cannot function or can function only temporarily with a serious impact on the customer’s productivity. Examples: User Cannot Sign In, Audit Reporting Issues, Documents not Opening, Notification issues.
Priority 8 Change Request	24 Hours	45-day target	Minor Issues that require repair in a software patch and cannot easily be repaired in a hotfix or application configuration changes. Includes requests concerning documentation, product enhancements, or other administrative matters. Examples: Change Request, Bug Fix, Patch Release.
Priority 7 Change Request	24 Hours	15-day target with 5-day update	Non-Standard Request involving multiple members, days of manual actions taking more than usual time to fulfill, Project Work.Examples: Bulk Request, Manual Add/Remove/Modifications on Domain, TMF, Users, Groups, UAT Setup.
Priority 9 Change Request	10 Days	None	Requests concerning documentation, product enhancements, or other administrative matters. Trial Interactive staff will evaluate whether to implement the proposed enhancement or change in the context of TransPerfect’s development plans. Examples: Enhancement, Major and Minor Release.
Priority 1 Incident (HIGH)	Within 30 minutes of initial contact	8-hour target with 1-hour updates	Service is down or unavailable. The issue renders the software completely inoperable. The customer business process can no longer continue due to reported errors or deficiencies in the application service, and data may be lost or corrupted. This priority also concerns any issue reported during a regulatory audit or inspection. Examples: Application Outage, Network Outage, Natural Disaster. Exception: Issue reported, Query raised during a regulatory Audit or Inspection (First Response - 15 Minutes, Timely Update: 30 Minutes, Closure: 2 Hours)
Priority 5 Service Request	8 Hours	7-day target with 3-day update	Standard Service Request with 1-week completion target. Examples: Hybrid Room Build (7 Days), Archive Request, Doc Type Config, Custom Index Structure.
Priority 6 Service Request	8 Hours	15-day target with 5-day update	Standard Service Request with 2-week completion target. Examples: Fresh Room builds (15 Days), Archive Request.
Priority 4 service request	8 Hours	48-hour target with 24-hour update	Standard Service Request with 48-hour completion target. Examples: Add/Modifying User/s Access, Room/Site Level Setting Change, Informational Queries.

Question: How are tickets escalated in support?

Answer: The TransPerfect Trial Interactive help desk application logs all tickets with a unique ticket ID number, and keeps track of the status and escalation of all tickets. All Client Service Representatives covering the TransPerfect Trial interactive help desk all fully trained and certified on all features and functions of the application. If in the event, however, a ticket comes in that the assigned client service representative is not able to complete, the ticket should immediately be escalated according to the following workflow:

Upon receipt of a ticket, the assigned Support Analyst will analyze the requirements of the request and determines whether or not it can be completed without escalation. If it is determined that the ticket cannot be completed without escalation, the SA will immediately escalate the ticket to a member of the Solutions Engineering staff.
If, when working on a ticket, a SA is unable to complete the ticket by the agreed-upon resolution time the SA will escalate the ticket to ensure completion.
The process for escalating a ticket consists of three parts:
- The assigned SA will forward the ticket on to TransPerfect Trial lnteractive’s internal distribution list for the SE Staff. The escalation should include the original request, a description of what work has been done on the ticket already, and the reason for the escalation.
- The member of the SE team who will be picking up the escalation will then let all members of the SA team know that they accept the escalation.
- The SA assigned to the ticket in the help desk application will then be updated to reflect the escalation of the ticket to the new support representative.
Trial Interactive will use commercially reasonable efforts to resolve Support Cases as soon as reasonably practicable. A Support Case is resolved upon the earlier of the following: (i) the issue or problem is resolved; (ii) if the issue or problem is the result of an Error, the provision of a Fix or Error Correction; (iii) Trial Interactive is able to provide an alternative solution; (iv) Trial Interactive confirms that the issue or problem is not due to an Error or deficiency in the Subscribed Software; (v) Trial Interactive confirms that the issue or problem is due to a multi-vendor issue; (vi) if the Support Case is attributable to Third Party Software, Trial Interactive logs a support request with the provider of such Third Party Software; (vii) the Customer requests that Trial Interactive close the Support Case; or (viii) the Support Case has been left open for longer than the Service Level Objective. A member of the senior staff will then follow up with the SE assigned to the ticket to ensure completion.
TransPerfect support beyond the Service Desk includes the following options that are defined in each SOW. This can include leading workshops, oversight of other technology integrations, customizations specific to Customer, product enhancements, on-site support, other user training, validation, and UAT, etc. All are billed at hourly rates defined in the SOW per the scope of work.
- Service Desk Analyst – the Service Desk representative, completes initial troubleshooting and escalates issues to Solutions Engineer.
- Project Manager - remains assigned to Customer: as needed at the agreed-upon a billable hourly rate or with a percent allocation each month to the Customer
- Solutions Engineer - easily accessible through Service Desk and Project Manager and will be billed at the agreed-upon hourly rate.
- System Architects and Developers - often engaged for migrations, integrations, new technology upgrades, etc.
- Quality Assurance - providing support on validation, UAT, and other client requests.
- Trainer – Training on the Trial Interactive applications as well as course and content development.
Executive Sponsor and Corporate Governance work with TI Product Management to ensure users are optimizing the functionality of the system, gathering feedback for enhancements to the next product release, training against new product releases and functionality.

Question: What are the requirements for Disaster Recovery for Trial Interactive?

Answer: TransPerfect has implemented both business continuity and a disaster recovery plan, which addresses all elements of our technical, physical, and organizational processes in the event of a disaster. Trial Interactive’s Cloud Environment has two hosting facilities to facilitate the Production and Disaster Recovery objectives of this infrastructure. Specific to our Trial Interactive and eTMF solution, our primary Cloud Environment is in Northern Virginia and our Disaster Recovery Cloud Environment is in Oregon.

TransPerfect has adopted incremental, full backup, and replication technologies for our backup and disaster recovery strategy; consequently, this also affords us the ability to adhere to any retention policy we are contractually obligated to meet. The system is backed up throughout the day, every 30 minutes via incremental backup, and every night via full backup. After we purge data from the application we can remove it from the backup set in accordance with the applied backup policy. We also have a data destruction procedure that involves physically destroying physical media as they are decommissioned.

These procedures ensure the continued delivery of services to clients in emergency situations that result in the interruption or failure of the computerized systems. Depending on the nature of the disaster, TransPerfect expects to be operational with little impact to any clients. TransPerfect has an annual verification of activities schedules, which tests the different components of our Disaster Recovery process.

Restoration Times:

Data restoration can be achieved in less than 24 hours from backup.
Recovery Point Objective (RPO) is 1 hour or less.
Recovery Time Objective (RTO) is 24 hours or less.

Question: What are the definitions needed for the SLA for Trial Interactive?

Answer: Definitions are below.

Off Hours means, typically 9pm– midnight in that regional time zone, EST for the Americas, GMT for Europe, and CST/JST for APAC.

Downtime means, for a server, if there is service failure or more than a five percent user error rate. User error is calculated using server monitoring software, based on results from ping tests, web server tests, TCP port tests, and website tests.

Emergency Downtime means those times where Trial Interactive becomes aware of a vulnerability or issue that, based on a risk assessment of the vulnerability or issue, TransPerfect deems to require immediate remediation and, as a result, the service is made temporarily unavailable in order for TransPerfect to address it. Emergency Downtime is not considered Downtime for purposes of Trial Interactive Uptime, and will not be counted towards any Downtime Periods.

Scheduled Downtime means those times where TransPerfect notifies you of periods of Downtime 48 hours prior to the commencement of such Downtime. Scheduled Downtime is not considered Downtime for purposes of Trial Interactive Uptime, and will not be counted towards any Downtime Periods.

Monthly Uptime Percentage means the total number of minutes in the calendar month minus the number of minutes of Downtime suffered from all Downtime Periods in the calendar month, divided by the total number of minutes in the calendar month. Uptime rate will be calculated using the following formula:

Uptime rate % =

Uptime Exclusions: The Uptime SLO does not apply to any performance issues: (i) caused by factors outside of TransPerfect's reasonable control; (ii) that resulted from any actions or inactions of Customer or any third parties; or (iii) that resulted from Customer equipment and/or third-party equipment (not within the primary control of TransPerfect.)