Study Delivery

Team

During the start-up phase, the following roles will be assigned to complete study build activities.

The Solution Manager (SM) oversees the implementation of the study build and is your primary point of contact for study-level questions or issues. Responsibilities of the SM include:
1. Facilitation of the study Kick Off Meeting.
2. Provision of weekly updates to the relevant Partner team.
3. Coordination of UAT activities.
4. Ensures study implementation activities are within scope, delivered on time, and high quality.
5. Maintenance of risk log, change order log, etc.
6. Development of the study workflow from the study documentation.
7. Creation, finalization, and maintenance of the Project Design Specifications document.
8. Leads design discussions between teams

The Data Scientist (DS) is ultimately responsible for the timely and accurate transfer of data, and contributes to development of the Data Transfer Agreement.

Depending on study scope, the Scale Management & Translation (SMT) representative will work with the SM, the Sponsor, and the copyright holder to obtain appropriate licenses, validated translations, and/or vendor agreements for validated instruments. The SMT will also plan the localization process based on submission needs and FPI dates, and coordinate with the translation vendor to obtain translations where scoped.

The Patient Success team will provide study-specific materials targeted to increase patient adoption and understanding of the study solution. Depending on study scope, the Patient Caregiver Network will provide patient feedback on study design, endpoints, and measurements that are relevant to patients. The Patient Caregiver Network representative can also support with study simulations and UAT.

Depending on study scope, a Site Success Associate will work with the Sponsor's sites and CRAs to provide a study-specific Site User Guide, attend the Investigator Meeting to provide training on the Medable platform, create and maintain a Site and CRA communication plan, and complete calls with sites and CRAs to provide hands on support. The Site Success Associate will provide ongoing support.

‍Global Services (GS) will be responsible for coordinating the logistics of devices procurement and shipment and providing support to the SM and the Partner on the documentation needed for import of devices into the country.

‍Customer Care provides support after the study enters the Monitoring Phase by managing the relationship and operations with the Help Desk provider on Tier 1 tickets, and is responsible for the resolution of Tier 2 and 3 tickets and their escalation plan. Customer Care works directly with the SM to ensure Help Desk is set up for the study by go-live.

Topics discussed

Timelines and Milestones:

1.  IRB Submissions

2.  PDS Draft delivery date

3.  PDS Sign-off

4.  Design Freeze

5.  UAT Start and sign-off

6.  Go-live

7.  Multi-Language deployment

8.  FPI dates

9. Final Report

Note: After the KOM, the PC shares the final KOM slides, reference documents, and the next steps plan with the Sponsor/CRO. Frequency of Client calls/meetings depends on the project complexity and timelines, however it is advised that at least two calls a week occur during the PDS development phase to discuss the project status.

Study Delivery

Team

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Meet the Team

Topics discussed

Version Control