Service Desk FAQ

Question: What is the process on 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, customer emails, 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 as per the emergency response procedure. This procedure is designed to ensure that resources with the correct subject management expertise are deployed and focused on finding a corrective action that will restore expected service levels. This procedure also describes the communication plan designed to provide regular updates to internal and external stakeholders. Any changes required to the production application services environment in order to resolve an incident are handled through the change management process.

When a request is received by the Service Desk, it should be managed according to the following workflow:

Level 1: Upon receipt of a request (call or Email), the assigned Service Desk Analyst will analyze the requirements of the Request or Incident and determines whether or not it can be completed without escalation. The SDA will create a ticket, inform the Client with an initial response, provide the ticket number and indicate the ticket is in progress. The Shift Lead of the Service Desk will triage and prioritize tickets as necessary based on priority and urgency and reassign as needed.
If the request concerns an existing ticket, the assigned Service Desk Analyst will retrieve the details of the request and provide the requested information, and if appropriate, reopen or continue work on the ticket.
If necessary, the assigned Service Desk Analyst will involve a senior member of the Service Desk, who will work with the SDA to ensure the ticket is closed within the SLA.
Level 2: If the Service Desk determines that the ticket requires additional technical oversight, or the issue cannot be resolved, or it concerns a specific type of Service Request or Change, the Service Desk Shift Lead will escalate the requirements of the ticket to the Solutions Engineering team.
- The ticket owner will assign the ticket on TransPerfect Trial lnteractive’s Service Desk system to the Solutions Engineering Staff. The escalation will include the original request, a description of what work has been done on the ticket already, and the reason for the escalation.
- The assigned SDA will communicate this escalation clearly to the Client. The SDA assigned to the ticket in the Service Desk system will then be updated to reflect the escalation of the ticket to the new support representative.
- The Solutions Engineer assigned will update the Client to reflect the investigation and expected time to complete and progress the ticket to closure.
Level 3: If the Solutions Engineers determine that the ticket requires even more technical oversight or a software change, or the issue cannot be resolved, the Solutions Engineers will escalate the requirements of the Request or Incident to the Trial Interactive Development team. From here, a development ticket is opened in the software development system as described in Change Control SOP TI-IT-002 for possible inclusion in the next patch.

Question: What is the approach for Investigative Site Support? How does Trial interactive support clinical sites directly?

Answer: Trial Interactive Investigative Site Support is support tailored to meet the specific needs of Life Sciences Clients and their investigative site partners. Through a breadth of services and personal attention to each clinical study, the desk supports investigative sites from site initiation through study completion. The ISS provides direct support to users at Investigative Sites who need assistance with user access, account management, questions about the system, Incidents, and defects. This desk is specifically contracted as part of the Site Collaborate, Remote Monitoring and eISF offerings in the Client SOW. This desk is characterized by local US and European phone support and a senior, high-expertise staff available to provide an enhanced level of guidance and assistance on questions, and a specific set of processes around user access and account management.

Response times for Investigative Site Support are defined as acknowledgement of the call/email and entry of the ticket into the Trial Interactive Service Desk system, and target response times are less than 30 minutes for all Incidents. Target resolutions for Incidents are within 5 days for all normal-priority tickets, and within 4-hours for high-priority tickets. High priority tickets are defined as any problems that cause the production system to fail to operate. Other priorities consist of moderate priority issues that impact multiple users but do not block the primary business process, and lower priority issues that only impact a single user on a non-critical process.

For tickets that are a potential system downtime, security incident, privacy incident, Agency or Mock Inspection, or GDPR/HIPAA issue involving PII/PHI, ISS will initiate the escalation process within 30 minutes of receipt of call or email received. Notification will be direct communication to the Client (Email, in person or via phone) from ISS.

Support includes both phone and email. For continuity at the end of each day, in some cases tickets will be escalated to the Service Desk team for resolution, which is available 24 hours per day, 7 days per week, 365 days per year, depending on privacy concerns based on local laws. In some cases, a ticket may be escalated to the Solutions Engineering team for resolution, but in all cases the local Investigative Site desk will manage the communication and resolution with the end user.

Question: How about Trial Interactive Premium Support? How is that handled?

Answer: The Trial Interactive Premium Service Desk is available to provide enhanced, hypercare-style 'white glove' support for an additional contracted support fee in the SOW. This desk is characterized by local phone availability, faster response times, and a senior, high-expertise staff available to provide an enhanced level of guidance and assistance on questions, Incidents, and Service Requests.

All newly implemented customers automatically receive 8-weeks of Hypercare support from the Premium desk.

Response times for Premium Support are defined as acknowledgement of the call/email and entry of the ticket into the Trial Interactive Service Desk system, and target response times are less than 30 minutes for all Incidents. Target resolutions for Incidents are within 5 days for all normal-priority tickets, and within 4-hours for high-priority tickets. High priority tickets are defined as any problems that cause the Client’s production system to fail to operate. Other priorities consist of moderate priority issues that impact multiple users but do not block the primary business process, and lower priority issues that only impact a single user on a non-critical process. Exceptions to this rule may apply to certain Clients as specified in their SLA which may state specific contractual response times for certain types of concerns.

For tickets that are a potential system downtime, security incident, privacy incident, Agency or Mock Inspection, or GDPR/HIPAA issue involving PII/PHI, Service Desk will initiate the escalation process within one 30 minutes of receipt of call or email received. Notification will be via Trial Interactive Professional Services as well as direct communication (Email, in person or via phone) through the Service Desk.

Question: What are the Service Desk numbers?

Answer: See below

Service Desk

Location: Pune, India and Chennai, India

Phone: 888-391-5111 (TOLL-FREE)
Email: help@trialinteractive.com (Specific Clients may be provided with their own Service Desk email address)
Business Hours: Available twenty-four (24) hours a day, seven (7) days a week, three-hundred-sixty-five (365) days a year

24/7/365 Level 2 support available in Chennai, India, London, UK and New York, NY

Premium Service Desk

Location: New York, US

• Availability Hours: Monday – Friday, 8:30AM – 6PM EST.

• Phone: (212) 400-8856

• Email: help@trialinteractive.com

Location: Barcelona, Spain

• Availability Hours: Monday – Friday, 9AM – 6PM CET.

• Phone: +44 (20) 45182755

• Email: eu.help@trialinteractive.com

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 describes 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: (i) transmit or share identification or password codes to persons other than authorized users (ii) permit the identification or password codes to be cached in proxy servers and accessed by individuals who are not authorized users, or (iii) 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 resolution for metrics tracking purposes. The help system can classify types of support needs for client to allow for review of trends and make recommendations on additional training requirements.

Maintenance Support Service

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 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 2 Incident (MEDIUM)	Within two (2) hours	24-hour target with 4-hour update	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 to the customer’s productivity. Examples: User Cannot Sign In, Audit Reporting Issues, Documents not Opening, Notification issues.
Priority 3 Incident (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 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.
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 build (15 Days), Archive Request.
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 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 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.

Question: How are tickets escalated in support?

Answer: The TransPerfect Trial Interactive service 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 service 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 Service Desk 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 SDA will immediately escalate the ticket to a member of the Solutions Engineering staff.
If, when working on a ticket, a SDA is unable to complete the ticket by the agreed upon resolution time the SDA will escalate the ticket to ensure completion.
The process for escalating a ticket consists of three parts:
- The assigned SDA 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 SDA team know that they accept the escalation.
- The SDA assigned to the ticket in the service 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 of 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 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 Americas Cloud Environment is in Northern Virginia and our Disaster Recovery Cloud Environment is in Oregon. For European customers, our primary Cloud Environment is in Frankfurt, Germany and our Disaster Recovery Cloud Environment is in Ireland.

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 twice a week 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 restore 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 general responsibilities of the Service Desk?

Answer: The following responsibilities for the Service Desk are defined below:
The Service Desk generally handles three kinds of tickets:
- Incidents – Priorities 1 thru 3. Incidents are issues, reported either by the Client or based on an internal Event or escalation. Incidents are governed by procedure (TI-CS-718)
- Service Requests – Priorities 4 thru 6. Service Requests are work effort and range from new implementations, configurations, or minor projects such as user management or document transfers. Service Requests are managed by procedure (TI-CS-718)
- Change Requests – Priorities 7 thru 9. Change Requests are typically defect fixes, enhancements, customizations and non-standard updates represented in the desk by patches or upgrades. Change Requests are managed by procedure (TI-IT-202)
Service Desk is responsible for ensuring that all calls and emails are responded to, tracked, and resolved in accordance with Service Desk procedures.
Service Desk management is responsible for overseeing compliance of this policy and to consult with appropriate functional areas to coordinate execution of the guidelines described.
Service Desk management is responsible for compiling metrics on all Service Desk tickets for reporting to executive management.
Premium Service Desk is responsible for an elevated level of service for Client service Requests, questions, problems, and Incidents, as described by the Premium Service Desk SLA.
Investigative Site Support is responsible for the management of GDPR policies and practices, specifically access management, account management, identity verification, and security of content that may contain PII/PHI.
Investigative Site Support is responsible to ensure that all information and content that may contain PII/PHI from European sponsors or Investigative Sites is stored securely within European hosting facilities, and that only personnel based in Europe control access to this information and content.
Investigative Site Support is responsible to securely verifying the identity of any and all Site and Sponsor personnel requesting access to data or content, in particular repositories that contain patient information.
For potential defects, it is the responsibility of Service Desk to attempt to reproduce the issue prior to requesting involvement by the Solutions Engineers. Likewise, Solutions Engineers must provide the appropriate steps to reproduce the issue prior to involving the Development teams.
Service Desk and Solutions Engineering are mutually responsible for the monitoring of the Trial Interactive hosted service, ensuring that any Events and Notifications are handled properly.
Solutions Engineering is responsible for handling any escalations that require additional technical knowledge and troubleshooting.
Solutions Engineering is responsible for reporting potential product defects, proposed Client enhancements and/or change requests in Development Management System as described in the Change Control SOP (TI-IT-202).
Development is responsible for investigation of possible defects as escalations from the Solutions Engineering team, and repair of these defects, and the creation of any necessary hot fixes, patches, or releases.
Professional Services is responsible for ensuring that all Client-related requests are taken care of in a timely fashion and represent the interests of the Client at all times.
Professional Services is responsible for ensuring the accuracy of the Client information on the Client record.
Technical Services is responsible for assisting in the planning and execution of client deployments, upgrades, integrations, migrations, bulk archives, and other special projects.
Quality Assurance is responsible to oversee that formal Client complaints are documented, investigated, and actioned (through the Compliance Reporting process), and provide procedural oversight to Support Services.

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.)