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Partnership Overview
This Playbook documents the standard Medable study implementation process within the COMPANY NAME and Medable partnership. COMPANY NAME will be referred to as the "Partner" throughout this Playbook.
All COMPANY NAME-specific processes are documented within the Appendix. All team members working on activities within the COMPANY NAME and Medable partnership should review this Playbook as part of their onboarding and consult this Playbook regularly.
Playbook Owners
The Medable owner of this playbook is the account Alliance Director: NAME.
The COMPANY NAME owner of this playbook is NAME.
The playbook owners have mutually agreed to the content of this playbook and agreed to review for updates on a quarterly basis. The playbook owners will be responsible for communicating updates to their respective teams.
Account Level Resources
At the time of onboarding, Medable will assign a resource to the following account-level roles. These account-level roles will be assigned for the duration of the partnership and are available to provide close support and guidance throughout the partnership.
Alliance Director
The Alliance Director (AD) provides operational oversight of the account. Responsibilities of the Alliance Director include:
- Maintains oversight of study-level activities, ensuring maximum consistency and quality across study implementations.
- Monitors and tracks account-level operational metrics.
- Facilitates education of partner teams by coordinating access to standard training, faciliating workshops, etc.
- Point of contact for onboarding new team members
- Primary point of contact for operational escalations or risks.
- Coordinates creation and maintenance of partnership workstreams.
- Is not the primary point of contact for study-specific questions, please see Digital Project Manager role in Study-Level Resources.
- Any requests pertaining to audits, technical qualification activities, etc, can be directed to the AD.
Tech Lead
A tech lead may be assigned as the primary point of contact for technical questions. Responsibilities of the tech lead include:
- Support review of study scope to assess technical complexity and feasibility.
- Act as intermediary between the Partner team and the Medable product team for any product or technical questions.
- Primary point of contact for integrations-related questions or workflows.
- Ensures continuity and consistency across tech resources assigned at the study level.
Executive Sponsor
The Executive Sponsor (ES) acts as "Voice of the Customer" to ensure the partnership drives towards delivery of successful outcomes and that partnership goals are met. The ES is the highest escalation point in the partnership.
Business Development
The Business Development (BD) representative is your primary point of contact for all contract and pricing-related discussions:
- Proposals and bid defenses
- Account-level contracting activities, such as SOW and MSA negotiation
- Study level contracting activities, such as study specific SOWs or COs and invoices
- Change Orders (Though incremental Change Order Log items will be administered via the Solution Manager, if a CoL is being used)
Governance Structure
During onboarding, the Alliance Director and Executive Sponsor will formally set up a partnership governance structure. Medable operates partnership governance according to the following structure.
Escalation Pathway
In the event issues arise throughout the partnership, escalations should be directed to Medable according to the following escalation pathway:
- Manage and oversee project implementation
- First point of contact for project-level questions or escalation
- Coordinate all Medable build team members
- Delayed shipments
- Application problems or errors
- Communication turnaround issues
- End-user training issues
- Project-level task turnaround timelines
- Project budgets
- Scope questions
- Provide oversight of account metrics and KPIs
- Drive implementation of operational standards
- Implements portfolio-level lessons learned
- Medable follow-up on escalation resolution
- Portfolio-level risks and questions
- Systemic issues across multiple studies
- Trending downward KPIs
- If applicable, enterprise-level contract terms and scope
- Oversees strategic initiatives involving the customer
- Voice of the Customer internally at Medable
Communication
Document Signature
All documents must be signed using the CFR part 11 compliant DocuSign system. If DocuSign is unavailable and signatures are needed in a timely manner, documents can be signed, scanned and emailed as a backup.
Primary and back-up partner signatories are noted in the appendix.
Document Versioning
The first draft version of a document will be 0.1.
The Partner will review version 0.1, add comments, make revisions in tracked changes, and provide to Medable for review. Medable and the Partner will collaborate on version 0.1 until all feedback is provided. During document reviews, do not delete comments. Comments should remain in each draft version. They can be removed once all agree that all items are resolved, the document is versioned to a whole number and ready for signature. Once all comments have been resolved and both the Partner agrees to all the changes, Medable will update the document to version 0.2. The cycle will continue as noted above with new versions until both agree to final at which point the document will be routed for signatures. The first signed version becomes version 1.0. The signed document will be filed by the SM in the agreed study file repository.
Email and phone call response times
Medable targets to respond to emails/voicemails within 1 business day. If a team member is unable to address the request, the receipt of the message is acknowledged and the team member informs that a full response is planned to be provided at a designated time period.
Absences
For planned absences, Medable strives to provide a minimum 5 business days notification to the Partner that includes contact details of the backup resource. For the duration of the planned absence, the resource will maintain an out-of-office auto reply listing the email of the backup resource. Medable does not provide phone numbers in out-of-office auto replies. In the event of an unplanned absence, Medable will provide a named backup as soon as possible to the Partner.
Escalations experienced at a site
When an issue requires escalation at a site, the Customer Care Help Desk is available to sites, patients, and the study team 24/7, 365 days a year. Users contact Help Desk using the numbers provided in the Patient App, training materials, and Medable’s website.
Meeting Communication
Medable will provide an agenda in advance of key meetings. The agenda provides the key topics for discussion as well as the standard items (e.g., timelines, metrics, action items, RAID Log). Agendas are brief, containing the topics to be discussed and ordered. Following the meeting, Medable will provide meeting minutes to attendees to document topics discussed, actions, decisions, risks, and issues identified. All standard communications that are the responsibility of Medable will be provide on Medable's standard templates.
Study Dashboard
During the planning phase, Partners receive access to a Smartsheet External Study Dashboard to review the project milestones, track upcoming tasks, open RAID items, and additional information in real time. Open actions and risks will be included in the agenda to discuss at the weeking meetings.
RAID Log
A RAID log is implemented at the portfolio level and for each study to capture relevant risks, actions, issues, and key decisions. Open actions and risks will be reviewed regularly to ensure prompt mitigation or closure.
Version History
The Partner will work with the account AD and BD to provide regular updates on upcoming study pipeline and timing as far in advance as possible so that Medable can plan for resourcing needs.