Catalent Clinical Supply Services

This workflow applies to shipments when you use an integration with Catalent Clinical Supply Services. It applies to all types of shipments, including the initial shipment to a site, a resupply shipment that is generated automatically when resupply runs, and a manual shipment.

Configuration Service details for this integration

B92664: Oracle Life Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.

For more information see, Oracle Life Sciences Cloud Consulting Professional Services, Service Descriptions and Metrics.

Prerequisites for sending the depot order form to Catalent-managed depot facilities

To make sure depot users at a Catalent-managed depot facility get this email notification in their inbox, in Oracle Clinical One Platform, on the Depot tab, check that the email field for depots managed by Catalent Clinical Supply Services is left blank. The integration is configured to send emails to the appropriate recipients. Further, in order for the integration to run as expected, ensure shipment ID prefixes consist only of numbers. When setting the prefix on the Supply Settings tab, in the Shipment Settings section, choose one of the following options:

• Use depot ID: depot IDs have been defined using numbers only
• Enter prefix: enter a prefix and make sure the values consists only of numbers
• None: if no prefix is used

Finally, in Oracle Clinical One Platform, make sure the value for Study Title is between 5 and 30 characters long.

Integration user details

Integration set up includes the creation of a study level integration user account, which is assigned the Clinical supply manager template role, or a custom role that includes the same permissions. The integration user account is created using the email address of one of your organization's clinical supply managers. The email address associated with the integration user receives integration notifications, which can include content resulting in unblinding.

WARNING:

Make sure the appropriate email address is configured for the integration user account to avoid unblinding issues.

For information about how to set up this integration, contact your Oracle Project Manager.

What information can be integrated?

This integration includes request and response components. You only need to implement what is necessary for your organization.

Available events:

• Shipment requests
• Automated shipment response - Confirmed
• In Transit
• Received

Available data points:

• For request:
  • Shipping site address
  • Site contact information
  • Site investigator information
  • Shipment depot and order details
• For response:
  • Shipment order
  • Tracking number
  • Shipment date, status, and delivery

Things to consider for shipments when you use an integration with Catalent Clinical Supply Services

If you need to update (add or remove kits from a shipment) or cancel a shipment after the shipment request has been sent to the depot, you must contact Catalent Clinical Supply Services directly. If you make any updates to shipments from within Oracle Clinical One Platform, the changes won't be sent to the depot. When the shipment is marked as Received, this status update applies to the entire shipment and all its kits are presumed Available. Therefore, all the kits in the shipment, including kits added after the original request, are updated once the shipment is received.

If a shipment request is sent in error or kits need to be added or removed, the clinical supply manager must contact Catalent Clinical Supply Services and request the shipment's cancellation. Once Catalent Clinical Supply Services cancels the order in their system, the shipment status changes to Invalid in Oracle Clinical One Platform.

Note:

Catalent Clinical Supply Services will only be able to cancel the order if the shipment hasn't been sent yet. To allow the resupply process to create a new shipment the next time inventory runs, the clinical supply manager must also explicitly cancel the shipment in Oracle Clinical One Platform.

Table 2-2 Status details

Status details
The status of a shipment changes automatically to Pending when a new shipment is raised.
The status changes automatically to Confirmed or Invalid when a shipment request is sent to the depot. Confirmed: indicates the depot received the request Invalid: indicates an issue occurred with the request Note: for an invalid shipment, a clinical supply manager should cancel the request and do one of the following: allow the resupply process to create a new shipment the next time inventory runs create a new manual shipment
The status changes to In Transit after the depot fulfills the shipment for a Confirmed request. The shipping date and tracking number are also set automatically.
Once the site receives the order, one of the following can happen: If the integration is configured to support this and the courier provides the information: Catalent Clinical Supply Services receives delivery information from the courier. The integration sets the status of the shipment to Received in Oracle Clinical One Platform. The status of all the kits included in the shipment automatically changes to Available. Additionally, the Date Received is updated in Oracle Clinical One Platform to reflect the date the integration processed the delivery file. This date may not always match the date at which the shipment is delivered by Catalent Clinical Supply Services. If the integration isn't configured to interpret the delivery as a receipt: a site user must manually mark the shipment as Received in Oracle Clinical One Platform.