Study Delivery

Introduction

The study enters maintenance when all the criteria below is met:

• 6 Weeks after FPI and / or localization Complete (localization generally takes longer)
• No subsequent releases scheduled
• No known high priority bugs
• Documentation complete and organized to spec
• All endpoints released

When the study enters maintenance, the assigned study build team transitions responsibilities to the assigned maintenance team. The assigned maintenance team becomes the point of contact with the Partner, and will make sure that the study continues to run smoothly until it is completed. If the Partner requires to change the scope of work during maintenance, this team will lead the following process to scope and implement any required changes.

Changes After Go-Live

Change orders are required when changes in scope are identified. Once changes in scope are brought to the assigned SM's attention, the SM and BD representative will execute a feasibility assessment to review the Change Order request and if approved, SM and BD prepare a change order and provide to the Partner for approval and sign-off. Medable needs full sign-off on the change order (or a Work At Risk) before Medable begins associated work.

In some instances, the Change Order request can be identified by Medable and on these scenarios, the SM and BD prepare the proposal to the Partner for review and approval.

Change Orders are approved/reviewed considering other factors such as CARE issues in Maintenance and pending deliverables. Change orders may also apply to device procurement; depending on the length of the study, devices deployed at the beginning of the study may no longer be viable to procure and may require a change order to address an update to device models.

When a change to the system is needed after a project’s Go Live, Medable is required to complete a Customer Configuration Change Request (CCCR) form. The CCCR form gives Medable the necessary access within PROD to create and implement the requested change. All CCCRs must be signed by both Medable and the Partner; Medable is not allowed to perform any changes in the live system until this document is signed. All changes made in the live system must be executed exactly as documented in the CCCR.  Examples of CCCRs include: Adding localized text to PROD, updating the project workflow due to a protocol amendment, troubleshooting site/patient issues). In the event a CCCR is required, Medable will complete a CCCR form and provide to the Partner for signature. Medable will implement the indicated changes, test accordingly, and then inform the Partner when the CCCR has been closed and changes are captured in PROD. In some instances a new UAT might be required and on these scenarios, the SM aligns with the Partner before on the process execution before any changes are deployed to PROD.

The CCCRs will have a period for completion, therefore it is extremely important that all signatures are provided on time, otherwise a new document is required to be opened and routed for signature. Changes already included in the original scope and PDS do not require a CCCR (e.g: Pending locales to be released, Regional orgs to be deployed) as the PDS serves as the validation document for any changes required.

Help Desk

Medable offers 24/7 phone, email and live chat support for studies via Medable employees and C3i (collectively, Customer Care). Medable trains, manages and oversees this team as one team. This allows us to have Medable employees on the “front lines” who understand our products and our Partner, combined with an industry experienced partner with global capabilities.

In advance of the targeted First Patient In date, the SM onboards Customer Care team  to be ready to provide help desk services on the study. This includes providing key study details to the Customer Care team, PROD environment links, an overview of the study design, information on user access roles, and any supplemental information that can be used to support questions about the study.

Once in Maintenance phase, the Customer Care (CC) Team supports studies in the following ways:

Tier 1: Support provided by Medable's Customer Care team and vendors as pertains to customer issues. Tier 1 Support does not typically require in-depth product experience to address inquiries.
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Tier 2: Support provided by Medable's internal Advanced Technical Support team pertains to more in-depth customer issues that require a higher level of product experience or technical expertise. Medable internal consultants at this level are Medable's Project Engineering Support and Customer Success team members, as required, to investigate and resolve an issue.
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Tier 3: Medable’s Product and Engineering teams provide this level of product support.

For more information, access the support website: https://www.medable.com/support/home