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Device Deployment
Medable provides end-to-end support for device management, if scoped. This starts with device suggestions and runs through procurement, provisioning, distribution shipping, support, and resupply. If Medable is scoped for device management, Medable and the Partner will define and finalize a deployment plan.
The Partner will need to provide:
- IOR information
- Devices per site and country
- Point of contact for countries
- Additional information for devices per country
Medable will provide:
- Average shipping time for contracted countries
- Devices information and guidelines
- Devices dashboard
To raise orders, the SM will share with the Partner a Smartsheet Form (available in the Study Smartsheet) to provide all the necessary information to raise the orders. Once the information is validated between both parties, Medable Global Services submits the order to the shipping vendor.
For Device returns, Medable provides the Partner a Smartsheet Form (available in the Study Smartsheet) to provide all the necessary information to return orders. Once the information is validated between both parties, Medable Global Services submits the return order to the shipping vendor.Return kits are sent 3 business days after the return order has been raised. Once return kit is received sites are instructed to:
- Place returning devices in a box
- Attach return label to outside of the box
- Coordinate with shipping courier on Device Pick-Up
Once devices are picked up and returned, Medable cleans the data from the devices and ensures any unsent data is sent out, sanitizes the devices and reallocates to study inventory.
Any Partner-specific standard processes for device shipping and logistics will be noted in the Appendix.
Go-Live
The SM and IM complete a Go Live checklist to ensure all necessary deployment processes are complete in advance of Go Live. The SM also drives completion of a study documentation checklist to ensure that all required documents are finalized for the study and available in the document repository.
Before the apps are submitted to the App Stores, the SM obtains Partner approval for moving forward with App Launch. The SM is also responsible for accounting for timelines for App approval in the Apple and Google Play stores - Medable maintains an App Store Submission reference guide to ensure that the process will be as seamless as possible.
Go Live is reached when the Medable solution developed for the study is released to the PROD environment in the App stores.
User Management
All study sites are required to be added in the Medable study solution, as are the individual site users and external users that require access to the Medable study solution. The SM will inform the Partner of the appropriate information and process flow needed to grant users access to PROD. Partners then provide the site and user-specific information; this process should begin after UAT approval so that access is granted on time.
Study End User Training
Site Education
The Partner is responsible for ensuring that all site users have completed training before accessing the Medable platform.
If scoped for the study, Medable can provide:
- Site training through Medable Academy's Site Certification pathway. This Site Certification pathway is not study-specific. Medable provides the Partner team access to the Learning Management System to review training records before the Partner requests site user access to the Medable platform.
- Site and CRA support and education through Medable's Site Success services.
Patient User Guide
Medable will provide a study-specific Patient User Guide. As a patient facing material, this document must submission to IRB/ECs and translated into the required languages if applicable.
Patient Success Support
Medable's Patient Success service provides a best in class experience for patients and caregivers participating in Medable-supported decentralized and hybridized clinical trials. Patient Success works to offer inclusive, diverse, and equitable clinical trials. Through Patient Success services, Medable offers its partners access to a diverse group of 60+ patients, caregivers, and care partners to provide input on study design. This service is available free of charge upon written client request.
Here are a few ways Patient Success supports:
1
Close Out: Supports facilitation of the collection of the devices on a site level. Ensures sites received the USB casebooks.
2
Close Out: Supports facilitation of the collection of the devices on a site level. Ensures sites received the USB casebooks.
3
Close Out: Supports facilitation of the collection of the devices on a site level. Ensures sites received the USB casebooks.
4
Close Out: Supports facilitation of the collection of the devices on a site level. Ensures sites received the USB casebooks.
The earlier Patient Success and the Patient Care Network are brought into the implementation plan, the better.
Site Success Support
The Site Success Team is on a mission to empower and support every site user within Medable’s studies and promote clinical best practices to maximize the adoption of Medable technologies. Depending on study scope, a dedicated Site Success Associate (SSA) is assigned to the study.
Here are a few ways Site Success supports:
1
Close Out: Supports facilitation of the collection of the devices on a site level. Ensures sites received the USB casebooks.
2
Close Out: Supports facilitation of the collection of the devices on a site level. Ensures sites received the USB casebooks.
3
Close Out: Supports facilitation of the collection of the devices on a site level. Ensures sites received the USB casebooks.
4
Close Out: Supports facilitation of the collection of the devices on a site level. Ensures sites received the USB casebooks.
5
Close Out: Supports facilitation of the collection of the devices on a site level. Ensures sites received the USB casebooks.
The Site Success Associate uses a Site Readiness checklist to ensure that all issues are documented and captured at each of these site calls/visits. The checklist is shared with the Customer Care Help Desk Team to ensure consistency and understanding of issues arising at the site level.
Medable’s Help Desk remains as the primary point of contact for platforms troubleshooting issues, however the Site Success Team interacts with sites to review their engagement level with Medable’s technologies and overall experience.