Merative Clinical Development
You can find support contact information and your Study login on the Merative Clinical Development Web Portal.
Severity 1: 1-hour response time target (maximum)
Critical business impact/service down:
Business critical functionality is inoperable or critical interface has failed. This applies to a production environment and indicates an inability to access services resulting in a critical impact on operations.
Severity 2: 2 business hours
Significant business impact:
A service business feature or function of the service is severely restricted in its use, or the customer is in jeopardy of missing established business deadlines.
Severity 3: 4 business hours
Some business impact:
Customer can continue with a workaround, but impact may increase if a resolution is not forthcoming. A medium impact on a user involves partial or limited loss of non-critical functionality, but a workaround exists that allows for the continuance of normal operations.
Severity 4: 1 business day
Minimum business impact:
Customer does not need resolution to continue work; no impact is seen on the user, and they can await a resolution to continue work. Involves no loss in functionality or is a general usage question, including questions that reference product documentation or request enhancements.
Response times objectives and rapid response definitions
Response time objectives described herein are intended to describe Support’s goals, differentiated from those of any other Merative teams. They represent our target, not a guarantee of performance, unless specified otherwise in your contract with Merative.
The customer will designate the severity for each request.
Merative and the customer will validate such severity and mutually agree to any changes based upon the severity description.
The incident "Response Time" is the elapsed time measured from the time the incident is reported to Merative Support by the customer/user.
Any tickets requiring a rapid response will be escalated outside of normal tier support and designated as “Rapid Response.”
The term “Rapid Response” is applied to any ticket that meets the following criteria:
- Business critcal production environment functionality is inoperable or critical interface has failed.
- Randomization or Dispense errors resulting in concern for patient safety.
- The cause of the issue is or could reasonably be assumed to be a technical cause over which Merative has direct control. If during troubleshooting an issue is determined to be of an external nature, Rapid Response protocol will be disengaged.
Support Service Level versus Consulting
- Support shall be made available upon request from a customer, subject to payment of the fees specified in the applicable order. There may be occasions where Support may not be able to answer all questions, but instead transfers incidents to other groups within the company. These transfers, if identified as being outside the scope of Baseline Support, fall under billable Consulting terms and require approval of the customer to proceed further. Clinical Development teams strive to identify issues that fall outside Baseline Support within the first 2 contacts between customers and our Support team.
- Merative will offer 24-hours-a-day, 7-days-a-week support access for Tier I support and for any tickets that fall under Clinical Development Rapid Response terms. All Tier II or Tier III tickets, once designated as such, will be processed during normal business hours (9am-5pm Eastern Time, Monday through Friday, excluding US Holidays).
- Support prioritizes work in order of incident severity, like most other Merative portfolios. The following table defines product-specific severity levels and targets for response to customers each time an incident is reported, or status is requested.
- All customer support issues will be documented within a support case.
- Each case will be assigned a unique number for reference and a severity level that is based on the details within the case description.
- Updated and customer responses will be sent by email and recorded in the case comments.
This section outlines the terms of Baseline Support versus Consulting/Services, and outlines which requests should fall under 'reasonable effort' basis.
Tier I Support
Any ticket directly related to the application in which we can resolve with minimal troubleshooting. These tickets typically take under 45-60 minutes of effort by Support.
Tier I sample tickets include:
- Application/System navigation.
- Account assistance.
- Browser-related issues.
- Searching/editing patient information.
- Creating search parameters.
- Documentation/data export.
- Determine escalation path to either Tier II or Tier III.
Tier I Exclusion Criteria include, but may not be limited to the following:
- Solutions cannot be found in our online manual at the time of request.
- Any request requiring direct access to a study that the support personnel does not have access to.
- Any hardware troubleshooting, such as connection to the Internet.
Tier II Support
Any ticket directly related to the application in which some troubleshooting is required.
Tier II sample tickets include:
- Budgeting/financial Items.
- Standard report creation.
- Design errors or function questions.
- Optional Modules questions.
- Application errors.
- Determine escalation path to Tier III.
- Application questions/issues that typically take more than 30 minutes of troubleshooting.
- Data interventions, in cases where normal application use has created duplicate or problematic data that is preventing users from performing necessary actions in the program.
Tier III Support (Consulting)
Any ticket directly or indirectly linked to the application in which customer-specific scenarios are required to understand.
These tickets may be resolved on the same day or may require multiple contacts and business days to resolve.
Issues that typically require more than 60 minutes of work time to resolve are not considered ‘Support’ Tier I or Tier II for Clinical Development. Such tickets usually result in the customer being advised to seek Tier III guidance. Tier III guidance falls outside the scope of Baseline support and fees are charged for services rendered.
Tier III sample tickets include:
- Training sessions.
- Business process or application best practice consultations.
- Data interventions to clean up previously entered data.
- Custom Report Building consulting (consulting fees may apply once consulting is approved).
- For more information on Tier III and Services Consulting, see the governing Service Description for this product.