Program snapshot, volume, and typical flow

• Tell me briefly about the therapy programs you manage and the typical monthly patient volume for each of your programs. Options: 1-5 patients/month, 6-20, 21-50, 51-100, 100+
• How many distinct clinical sites and collection centers are involved in your representative patient journeys? Options: Single site, 2-5 sites, 6-10 sites, More than 10
• Walk me through the sequence of milestones your team tracks from enrollment to infusion for a representative patient, including typical timing windows between steps.
• Which roles on your team currently own scheduling, patient outreach, slot confirmations, and escalation for these programs? Options: Clinical operations director, Patient coordinator, Site scheduler, Logistics manager, Clinical research nurse, Third-party vendor, Other
• When a patient falls out of your planned treatment window, what immediate downstream impacts do you see on manufacturing, slot availability, or patient eligibility?
• If a single site's repeated failures could stop a cohort or pause manufacturing, which specific failure at that site would make your team halt new enrollments immediately?

Where timelines slip and the cost shows up

• What recurring coordination failure in your program causes the most manufacturing delays or product expirations?
• Who within your organization usually detects a schedule risk first, and how does that person or team raise the issue? Options: Site staff, Patient coordinator, Manufacturing liaison, Clinical operations leadership, Automated alert, Other
• Which step in your treatment sequence sees the highest frequency of missed appointments—apheresis, lymphodepletion, manufacturing hold, or infusion? Options: Apheresis, Lymphodepletion, Manufacturing hold, Infusion, Other
• Describe a recent incident in your program where a communication breakdown led to a missed window and what your team had to do to recover.
• Where do most of your scheduling conflicts originate—site capacity, patient travel, manufacturer sloting, or data mismatches? Options: Site capacity, Patient travel, Manufacturer sloting, Data mismatches, Other
• If you could point to one metric that, if it did not improve within three months, would force your team to change the coordination approach, which metric would that be? Options: Missed treatment rate, Time from collection to infusion, Patient dropout rate, Slot utilization, Patient satisfaction, Other

The patient experience when schedules go wrong

• Tell me how patients in your programs typically react when a treatment step is delayed, and who on your team manages their emotional and logistical needs.
• List the patient-facing channels your team uses for reminders and confirmations, and identify which channels get the best responses from your patients. Options: Text/SMS, Phone call, Patient portal, Email, Caregiver contact, Automated reminders, Other
• When patients report confusion about pre-treatment requirements in your program, how long does it usually take your team to resolve the issue and who follows up?
• Who on your team is authorized to approve urgent travel or lodging exceptions for a patient and what is the typical approval timeline? Options: Clinical operations director, Site PI, Patient coordinator, Logistics manager, Other
• Describe a case from your programs where travel logistics directly caused a missed appointment and what policy or resource would have prevented it.
• At what point would rising patient distress from scheduling failures force your leadership to change the coordination process immediately?

Scaling assumptions and staffing gaps

• Point to the part of scaling from trial to commercial volumes that you expect will be hardest for your team to staff or maintain in-house.
• How many full time coordinators does your organization currently dedicate to these advanced therapy programs? Options: 0, 1-2, 3-5, 6-10, More than 10
• Estimate the typical monthly caseload per coordinator on your team and where overloads tend to occur.
• Name the people or teams your organization relies on to cover overflow during peak weeks or site outages and state typical lead times to secure that support.
• Explain the cost or quality trade-off that matters most to your leadership when choosing between hiring more headcount and outsourcing coordination.
• Identify the single staffing constraint within your organization that would force you to engage an external coordination partner immediately.

Integration and data gates we cannot ignore

• List the systems on your side that must exchange schedule or patient milestone data for coordination to work, and mark which of those have documented APIs. Options: Electronic health record, Site scheduling platform, Manufacturer slot portal, CRM or trial management, Data warehouse, Patient portal, Other
• Assign which team on your side owns each integration and provide the technical contact who would manage API access and testing.
• Are patient-level data sharing and PHI transfers already approved for external vendors in your organization, and if not which approvals are still pending? Options: Fully approved, Partial approvals in place, Pending privacy review, Not permitted, Unsure
• Explain any SSO, certificate, or security scanning requirements your IT or security team requires before we can connect platforms.
• Given a critical integration on your side could not be delivered before your target launch date, would your team pause launch, accept a manual workaround, or adjust scope? Options: Pause launch, Accept manual workaround, Adjust scope and launch, Other

The alternatives you're weighing

• Outline the options your team is actively considering now, including incumbent vendors, internal build, and third-party coordinators. Options: Incumbent vendor, Internal build, New external vendor, Use existing site staff, Temporary agency staff, Other
• Indicate which of those alternatives currently has the strongest support among procurement, clinical operations, and legal inside your organization. Options: Procurement, Clinical operations, Legal, Executive sponsor, No clear support, Other
• State the measurable improvement that would have to occur for your team to remain with the current approach instead of switching to a new vendor.
• Has anyone inside your organization proposed solving coordination internally, and if so what timeline and budget did they estimate? Options: Yes, under 3 months, Yes, 3-6 months, Yes, over 6 months, No internal proposal, Unsure
• What single proof point or pilot result would make your team switch providers within 30 days?

Readiness facts that gate launch

• Specify the concrete readiness facts that must be true at each site before your team will sign off on a go-live date. Options: Named site owner assigned, Site contact list verified, Slot booking dependencies confirmed, Patient data access granted, Travel vendors contracted, Training scheduled, Other
• Provide the named owner at each site that your team expects to be accountable and include their contact method and backup.
• Confirm whether your slot-booking dependencies require manufacturer approval, internal scheduling changes, or both. Options: Manufacturer approval required, Site scheduling change required, Both, Neither, Unsure
• Share any regulatory, consent, or contract approvals that typically delay site readiness for your programs and average approval times.
• Point to the single missing readiness item at the site level that would immediately block your team's launch.

Decision mechanics and acceptance criteria

• Assuming a pilot demonstrates the outcomes your team needs, what internal approvals would allow you to move to a full contract within 30 days?
• Provide the KPIs your team would require in contract SLAs to accept the pilot and to accept the scaled program. Options: On-time milestone rate, Missed treatment rate, Time from collection to infusion, Slot utilization, Patient satisfaction, Escalation response time, Other
• Detail the budget authority and procurement steps required for your team to finalize commercial terms once acceptance criteria are met.
• Estimate how long your legal team typically needs to complete vendor contracts and which clauses usually require negotiation.
• Should the pilot meet targets but leadership cannot free budget, what alternative approval or commercial structure would allow your team to proceed immediately?

Designing a pilot that proves value fast

• Define the smallest-scope pilot your team believes would prove coordination value to both operations and procurement.
• Specify the number of patients and sites your team would include to make the pilot statistically and operationally meaningful. Options: 1-5 patients, 6-15, 16-30, More than 30
• Identify the executive sponsor on your side who can unblock procurement or legal quickly if the pilot succeeds.
• Split the operational readouts your team would want weekly versus monthly during the pilot. Options: Weekly: milestone adherence, escalations, Monthly: throughput, patient satisfaction, cost, Other
• Given a 30% reduction in missed treatments during the pilot, would your team be prepared to sign a statement of intent within two weeks? Options: Yes, Maybe with review, No

• Care Coordination Experience Workshop

• Confirm the current state and its cost
• You confirm the demonstrated workflow prevents the specific treatment-window failures and manufacturing delays described in Discovery.
• Produce a mapped coordination workflow for the reviewed patient case, including named handoffs, escalation rules, timing constraints, and acceptance criteria, to deliver before the follow-up session.
• You agree that escalation triggers cover each cited failure mode, including site non-response, missed pre-treatment steps, and logistics conflicts.
• Map a representative patient journey end-to-end
• Provide one representative patient case timeline with exact dates, milestone history, and any past failure modes to use in the pilot mapping.
• You commit to a pilot case and identify the remaining evidence needed for a purchasing decision.
• Apply the proposed coordination workflow to the real-case timeline
• Provide a list of primary site contacts and preferred escalation contacts for each involved site.
• Validate the future state aloud
• Schedule the follow-up review to validate the pilot outputs once the mapped workflow is applied to the pilot case.
• Agree next evidence and pilot steps

• Care Coordination Experience Workshop
• Care Coordination Experience Deck
• Care Coordination Solution Brief

• meeting
• slides
• document

• Assign Dedicated Patient Coordinator
• Manage Patient Enrollment and Intake Forms
• Coordinate Apheresis and Collection Appointments
• Coordinate Lymphodepletion and Infusion Scheduling
• Book Manufacturing Slots and Timeline Integration
• Deploy Patient Portal for Schedule Visibility
• Real-Time Treatment Milestone Tracking and Alerts
• Arrange Patient Travel, Lodging, and Caregiver Logistics
• Escalation and Issue Resolution for Scheduling Conflicts
• Manage Medical and Administrative Documentation Flow
• Coordinate Inter-site Transport and Chain-of-Custody Handoffs
• Provide Post-Infusion Follow-up and Window Compliance Monitoring
• Activate Surge Coordinator Pool for Volume Ramps

Assign Dedicated Patient Coordinator

• Who will be the single point of contact on your team for coordinator onboarding and case escalations?
• How many full-time equivalent coordinators do you expect to require per treatment cohort of 10 active patients per month? Options: 0-1, 1-2, 2-4, 4+
• Do you require coordinators with prior experience in apheresis center workflows or infusion center operations? Options: Yes, No
• Which clinical certifications or background should the coordinator possess (for example certified nursing assistant, clinical trial coordinator with apheresis experience)?
• When should coordinator shadowing at the apheresis or infusion site be completed relative to first scheduled apheresis (for example 2 weeks prior)? Options: No shadowing required, 1 week prior, 2 weeks prior, 4 weeks prior
• What acceptance criteria will confirm coordinator onboarding is complete (for example completed HIPAA training, site shadowing checklist signed, and access to the patient portal)?

Manage Patient Enrollment and Intake Forms

• Do you use a standard Health Insurance Portability and Accountability Act (HIPAA) authorization or a study-specific medical release for each patient? Options: Standard HIPAA authorization, Study-specific release, Both, Not yet defined
• How will intake forms be delivered to patients: paper at clinic, secure e-signature link, or uploaded by site staff into your current platform? Options: Paper at clinic, Secure e-signature link, Upload by site staff, Other
• Which specific clinical documents must be collected during intake (for example recent CBC, infectious disease screening, and eligibility checklist)?
• What is the maximum acceptable turnaround time for completed intake documentation before apheresis (for example 48 hours, 72 hours)? Options: 24 hours, 48 hours, 72 hours, Custom
• Who on your team will validate medical eligibility documents for scheduling (physician, research nurse, sponsor medical monitor)? Options: Physician, Research nurse, Sponsor medical monitor, Other
• Do you require us to maintain an enrollment register with locked timestamps for each eligibility milestone (consent date, screening labs date, enrollment confirmation)? Options: Yes, No

Coordinate Apheresis and Collection Appointments

• Which apheresis centers are in your planned network and do any require pre-approval credentials or privileging for our coordinators?
• How many collection slots per week must be reserved for your program at each apheresis center during ramp-up? Options: 1-2, 3-5, 6-10, 10+
• What is the required window between apheresis and the start of manufacturing (for example 24-72 hours) that we must protect when booking collection dates? Options: 24 hours, 48 hours, 72 hours, Custom
• Do apheresis centers require specific consent forms or collection kits to be present on-site before patient arrival? Options: Yes, No, Depends on center
• How should unexpected collection delays be prioritized relative to manufacturing cutoffs (for example hold manufacturing slot, move to next available slot)? Options: Hold manufacturing slot, Move to next slot, Escalate to sponsor for decision, Other
• Which contact method do apheresis centers prefer for day-of coordination (phone call, secure SMS, portal message) and provide an example contact that we can test? Options: Phone call, Secure SMS, Portal message, Email

Coordinate Lymphodepletion and Infusion Scheduling

• What lymphodepletion regimen names and start-date constraints must be reflected in scheduling rules (for example fludarabine/cyclophosphamide starting exactly 5 days prior to infusion)?
• How long is the allowable infusion window from product thaw/arrival to patient infusion for your therapy (for example 6 hours, 8 hours)? Options: <4 hours, 4-6 hours, 6-8 hours, 8+ hours
• Who authorizes same-day infusion exceptions if a patient misses pre-infusion labs (physician, pharmacy lead, sponsor medical monitor)? Options: Physician, Pharmacy lead, Sponsor medical monitor, Other
• Do infusion centers require pharmacy or cell-product verification steps that our coordinators must schedule (for example bedside product ID confirmation, product thaw window signoff)? Options: Yes, No
• When should pre-infusion lab draws be scheduled relative to infusion (for example within 24 hours, 48 hours), and which lab values are hard-stop criteria? Options: Within 24 hours, Within 48 hours, Custom
• Describe the escalation path if lymphodepletion chemotherapy is delayed and the infusion window is at risk, including expected notification times to the manufacturer and clinical team.

Book Manufacturing Slots and Timeline Integration

• Which integration endpoints will we use to book manufacturing slots (for example slot booking API base URL or secure SFTP), and provide an integration test contact?
• How many guaranteed manufacturing slots per month are in contract or required for initial commercial launch? Options: 1-5, 6-20, 21-50, 50+
• What is the required API response SLA for slot availability queries (for example under 5 seconds for booking confirmation)? Options: <1s, <3s, <5s, Custom
• Do manufacturing timelines include fixed cutoffs we must enforce (for example collection must occur by 09:00 local to hit same-day pack-out)? Options: Yes, No
• What evidence will validate that the manufacturing slot integration is operational (for example successful booking of a slot ID via the integration endpoint and a confirmation receipt)?
• Who on your team will approve changes to booked manufacturing timelines after an apheresis delay (clinical operations lead, sponsor rep)? Options: Clinical operations lead, Sponsor rep, Other

Deploy Patient Portal for Schedule Visibility

• Which patient data fields must be visible in the portal for each milestone (for example upcoming apheresis date/time, manufacturing slot ID, infusion appointment)?
• Do you require single sign-on (SSO) for your clinical staff and separate patient authentication flows for caregivers? Options: SSO for staff only, SSO for staff and patients, No SSO required
• What language support is required for patient-facing portal content (for example English, Spanish, other languages)? Options: English, Spanish, Other
• How will you verify portal readiness before launch (for example named users, successful SSO login, visibility of apheresis and infusion slots)?
• Do you require audit logs for patient portal actions (for example who viewed or edited a scheduling milestone and timestamp)? Options: Yes, No
• Would you like portal notifications for patients tied to specific events (collection confirmed, manufacturing slot assigned, infusion scheduled)? Options: Yes, No

Real-Time Treatment Milestone Tracking and Alerts

• Which milestones must be tracked in real time (for example consent signed, apheresis complete with collection ID, product shipped with tracking number)?
• What notification channels should be used for milestone alerts to clinicians and coordinators (for example secure email, SMS, portal push)? Options: Secure email, SMS, Portal push, Phone call
• What are the critical alert thresholds that require immediate escalation (for example missed apheresis, failed product thaw, missed infusion window)?
• How frequently must milestone status sync with the manufacturer system (for example near real time, hourly batch)? Options: Near real time, Every 15 minutes, Hourly batch, Daily
• Do you require a dashboard view that shows at-a-glance window risk per patient (for example red/amber/green by infusion window hours remaining)? Options: Yes, No
• Who is the escalation owner when a real-time alert is triggered (coordinator on duty, clinical operations director, on-call physician)? Options: Coordinator on duty, Clinical operations director, On-call physician, Other

Arrange Patient Travel, Lodging, and Caregiver Logistics

• Do you have a travel policy that defines allowable airfare class, lodging per diem, and caregiver reimbursement that we must enforce? Options: Yes, No
• How far in advance should travel be booked relative to planned apheresis or infusion (for example 7 days, 14 days)? Options: 3 days, 7 days, 14 days, Custom
• Which documentation is required for travel authorization and expense reconciliation (for example physician travel authorization, receipts, confirmation codes)?
• Do you need coordinators to manage complex itineraries that include cold-chain courier handoffs tied to patient travel (for example same-day product receipt aligned to patient arrival)? Options: Yes, No
• What are the emergency travel contingencies we must plan for (for example patient hospitalization, cancelled flights within 24 hours of infusion)?
• Would you like pre-approved hotel blocks or caregiver lodging options arranged for high-volume sites? Options: Yes, No, Conditional

Escalation and Issue Resolution for Scheduling Conflicts

• Who is the primary escalation contact at your organization for schedule conflicts that risk missing a treatment window?
• What maximum time-to-response SLA do you require for tier-1 scheduling conflicts (for example 30 minutes, 2 hours)? Options: 15 minutes, 30 minutes, 1 hour, 2 hours
• Which decision authority is required to rebook a manufacturing slot after an apheresis delay (for example sponsor medical monitor or clinical operations director)? Options: Sponsor medical monitor, Clinical operations director, Other
• Describe the required documentation we must produce when escalating a scheduling conflict (for example timestamped event log, patient consent for date change, clinical justification).
• Do you require escalation drills before launch to validate the end-to-end conflict resolution path (for example simulated missed apheresis scenario)? Options: Yes, No
• Which stakeholders must be copied on high-severity escalations (for example pharmacy lead, manufacturer operations, site director)?

Manage Medical and Administrative Documentation Flow

• Which document types must flow between sites, sponsor, and manufacturer (for example pathology reports, informed consent, chain-of-custody forms)?
• Do documents require structured metadata tags for milestone mapping (for example patient ID, collection ID, sample type)? Options: Yes, No
• How long must we retain medical and administrative documents in the system for audit readiness (for example 7 years, per sponsor policy)? Options: 1 year, 3 years, 7 years, Per sponsor policy
• What secure transfer method do your sites prefer for medical documents (for example encrypted portal upload, secure email, SFTP)? Options: Encrypted portal upload, Secure email, SFTP, Other
• Who approves release of medical records between treating sites and the manufacturer (for example patient-authorized release, site medical director)? Options: Patient-authorized release, Site medical director, Other
• Do you require automated reminders for outstanding administrative documents tied to a milestone (for example missing labs before infusion)? Options: Yes, No

• Master Services Agreement (MSA)
• Statement of Work (SOW)
• Service Level Agreement (SLA)
• Order Form & Pricing Schedule
• Data Processing Agreement (HIPAA Business Associate Addendum)
• Escalation Protocol Addendum
• Program Acceptance Criteria & Site Readiness Checklist
• Service Commencement & Acceptance Certificate
• Payment Terms & Invoicing Schedule
• Change Order Agreement
• Termination & Transition Plan

• Go-live Health Check (weeks 1-4)
• First Measurement Review (weeks 4-10)
• Acceptance Gate — Outcome Acceptance Decision (around day 90)
• Quarterly Operational Review
• Annual Outcomes Retrospective

• Resolve the top three recurring coordination incidents and provide a closure report to the shared channel.
• Document remediation items, their resolution timelines, and verification method for any criteria not met at the meeting.
• Publish the acceptance decision record, including pass/fail per criterion and signatory notation, into the shared journey workspace.
• Initiate remediation tasks for any failed or conditional items with clear resolution dates and verification steps.
• Schedule a verification check once remediation items are complete to confirm achievement of outstanding criteria.
• Trend review against Service Scope targets
• Confirm whether quarterly trends for treatment window adherence rate and escalation response time meet or require adjustment relative to targets recorded in Service Scope.
• Prioritize and assign remediation or enhancement tasks for the top recurring incidents and backlog items.
• Validate capacity forecasts to ensure upcoming volume will not degrade agreed outcomes.
• Reconfirm success criteria and named owners
• Schedule an escalation drill for any site with repeated missed-treatment incidents and report results at the next quarterly review.
• Publish the prioritized enhancement backlog and expected delivery quarter for each item.
• Annual outcome summary
• Confirm whether annual outcomes for treatment window adherence rate and patient satisfaction meet the targets recorded in Service Scope and document any gaps.
• Identify systemic changes required to close recurring gaps and commit to a timeline for their implementation.
• Clean up the open enhancement backlog by retiring low-value items and scheduling high-value items into the operational plan.
• Archive resolved incidents and update the shared issue channel with closure notes and lessons learned.
• Create a proposal for any agreed systemic improvement workstreams with timelines and verification criteria.
• Publish the annual outcomes summary and the 12-month monitoring plan to the shared workspace.
• All deployment readiness facts from Service Scope are confirmed or have an assigned remediation action with a due date.
• Open launch blockers are documented with owners and target resolution dates to restore expected operations.
• Publish the launch remediation plan with issue list and target resolution dates in the shared channel.
• Enable or correct any missing patient data access and portal role mappings required for scheduling operations.
• Schedule a follow-up sync for any high-risk site with unresolved slot-booking dependencies.
• Present first-period outcome data
• Decide whether current KPI trends for treatment window adherence rate and appointment no-show rate are on track to meet targets recorded in Service Scope.
• Assign specific corrective actions with resolution dates to close gaps before the acceptance gate.
• Confirm reliable data sources and calculation methods for the named metrics for future measurement.
• Implement the agreed scheduling process adjustment to reduce appointment no-shows and report weekly results.
• Update slot booking integration settings to improve slot booking success rate and validate with a 7-day test window.
• Deliver a validated KPI export for treatment window adherence rate and appointment no-show rate ahead of the acceptance gate meeting.
• Restate acceptance criteria and numeric targets
• Produce a documented acceptance decision that records pass or fail status for each numeric criterion from Service Scope with the buyer's named signatory indicated.
• Deployment facts verification
• Detailed review on recurring incidents
• Present outcome data versus each acceptance criterion
• Trend and root-cause analysis
• Root-cause diagnosis for gaps
• Early adoption and usage signals
• Patient experience and escalation signals
• Enhancement request backlog triage
• Review unresolved blockers and enhancement backlog
• Document pass/fail per criterion and capture decision
• Agree closing actions and handoff for ongoing maintenance
• Blocker triage
• Agree remediation plan for any failed criteria
• Confirm corrective actions and timeline to acceptance gate
• Operational capacity and scalability signals
• Agree immediate remediation actions
• Agree actions and next steps
• Validate data sources and measurement fidelity