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Patient Coordination
Regulated development and commercialization journeys where clinical, quality, and market access align.
CATO Research Services
PSI CRO
ICON
Parexel
Inside this journey
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Pre-Discovery
Align the room on outcomes, decision process, and constraints before deeper discovery.
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Stakeholder Alignment
Confirm decision roles, timelines, escalation paths, and the clinical stakeholders needed to protect patient treatment windows.
Alignment Questions
Quick Grounding — Who You Are and What You Own
- What's your primary role and title for the programs you manage?
- Which therapeutic area or program type are we discussing today?
- Tell us at a glance: how many active patients per month are you coordinating today (ballpark)?
- Is this program in clinical development, transitioning to commercial, or already commercial?
- Briefly describe one recent scheduling or coordination issue that felt urgent—what happened in two or three sentences?
What Keeps You Up at Night About Treatment Timelines?
- If you had to name the single scheduling failure most likely to derail a patient’s treatment window, what would it be?
- How often do you experience events that threaten a treatment window (no-shows, missed apheresis, site non-responsiveness)?
- Which of the following failure modes do you see most often? (Select all that apply)
- When those failures occur, which immediate consequence hits first (operational, clinical, emotional)?
- How long has this pattern been happening at your program?
When Systems Fail a Patient — A Deeper Look
- Think of the last time a patient’s treatment window was at real risk—what failed first?
- Which stakeholders were involved in that breakdown? (Select all that applied)
- Which communication channels were used and which one failed to deliver? (Select all used; then tell us which failed)
- Describe the moment you realized escalation was required—what indicators tipped you off?
- How quickly do you typically resolve these incidents once identified?
Who Holds the Keys — Roles, Responsibilities, and Gaps
- If you had to pick one role that most often prevents missed milestones, who would it be—and why does that person matter?
- Which of these functions are clearly owned inside your organization today? (Select all that apply)
- Where do you see the biggest accountability gaps right now?
- What is your current coordinator model?
- Approximately what coordinator-to-patient ratio feels sustainable for your program?
- Which training or experience gaps do you see most often in coordinators that contribute to issues?
What 'Zero Missed Windows' Actually Requires
- If achieving 'zero missed windows' were realistic, what single daily habit or capability would have to change in your operations?
- Which metrics would you use to prove a coordination solution is working for you? (Select top indicators)
- What percentage change in those metrics would make you convinced the program is successful?
- How often do you need performance reporting (and in what format) to feel in control?
- Describe one small, testable improvement you would accept as proof-of-concept (pilot) success.
Trade-offs We Live With (and the Risks They Carry)
- What current manual workaround do you dread the most—one that you know is fragile but keeps things moving?
- Which of the following trade-offs are you actively making today? (Select all that apply)
- How often do those workarounds produce a near-miss that required an all-hands response?
- What would be the hardest part about removing those workarounds—culture, budget, technology, or something else?
- If you could eliminate one trade-off immediately without cost penalty, which would you choose and why?
Deciding to Change — What Would Make You Say Yes Today?
- What's the single operational guarantee that would make you sign a coordination agreement today?
- Which commercial flexibility matters most when choosing a partner?
- What integrations or data feeds are non-negotiable for you? (Select all required)
- Who are the decision stakeholders we would need to convince, and what's their main concern? (List names/roles and a one-line concern for each)
- Realistically, what's your decision timeline for a coordination partner?
- What are the top three internal blockers to procurement or pilot approval we should anticipate?
- Would you be open to a focused pilot that guarantees a defined improvement in a single KPI? If yes, which KPI would you prefer to pilot against?
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Current State Mapping
Document the end-to-end treatment workflow, failure modes (no-shows, missed apheresis, site non-responsiveness), and system touchpoints.
Current State
Start Here: A Quick Program Snapshot
- What is your title and the program (trial/commercial) you currently manage?
- Which therapy modalities are you coordinating today?
- How many active patients are in the current cohort you support?
- How many distinct clinical sites (collection + infusion) does a typical patient interact with?
- Briefly map your typical end-to-end treatment timeline (key milestones and typical durations).
- What systems or tools do your team use every day to track patient milestones?
Where Timelines Turn Into Crises
- What is the single recurring failure that most often converts a planned treatment window into a crisis?
- Roughly how often do those failures occur across your patients?
- Which failure modes do you see most frequently?
- Share one anonymized example of a recent failure and the cascading impacts it created (manufacturing loss, reschedule complexity, patient harm).
- Who typically first identifies the issue when a timeline breaks?
- From detection to a concrete remediation plan, how long does your team typically take?
When the Phone Goes Silent: Site Communication and Escalation
- How often do sites go silent at critical moments, and what do you believe is the root cause?
- Which communication channels do sites prefer—and which ones most often fail when speed matters?
- Do you have a documented escalation path for site non-responsiveness?
- How quickly are non-responses escalated under your current process?
- Who must be looped in for clinical decisions if a site cannot perform a scheduled step on time?
- Describe one scenario where escalation successfully prevented a missed window and one where it failed—what differed in each case?
If We Aimed for Zero Missed Windows — What Would Change?
- If zero missed treatment windows were non-negotiable, what current behaviors or processes would you have to stop tolerating today?
- Which measurable success signals would prove to you the program is operating without missed windows?
- What specific thresholds do you use (or would you use) to define 'on-time' for each milestone?
- How do missed milestones today affect patient experience, caregiver trust, and retention?
- Which constraints would be hardest to change to achieve zero missed windows?
- What cadence and type of reporting (alerts, dashboards) would make you confident that milestones are safe day-to-day?
Who’s In the Hot Seat When Things Go Wrong?
- When timelines break and product/slot risk emerges, who truly owns the decision to delay, reschedule, or proceed—and is that ownership crystal clear?
- Which decision roles exist today (who can approve reschedule, cancel, escalate to manufacturer, change lymphodepletion timing)?
- Do you have SLAs or required response times tied to each role for critical issues?
- How are handoffs and ownership between coordinator, site, manufacturer, and sponsor tracked or verified?
- How often do disputes about responsibility create delays in remediation?
- What would make taking ownership and escalating feel less risky or politically fraught within your organization?
The Technology That Holds the Journey Together (or Lets It Fall Apart)
- If one system fails right now, which failure would create the most immediate patient risk and why?
- Which systems are currently part of your tech stack for coordination and tracking?
- Do you have real-time integrations from sites/manufacturers feeding a single operational view?
- Which data elements must be real-time to prevent missed windows?
- How do coordinators currently get alerted to at-risk patients (and how reliable are those alerts)?
- What privacy, security, or integration constraints would we need to navigate for deeper system access?
If We Tried One Pilot — What Would It Take to Win?
- What single change tested in a focused pilot would most convincingly prove we can eliminate the most critical missed milestones?
- What pilot scale would you consider reasonable to demonstrate impact (patients/sites)?
- Which objective success metrics would make you approve expansion?
- Who internally must be engaged for a pilot to proceed and roughly how much time would they need to commit?
- What budget range and contracting timeline would you expect for a pilot this quarter?
- What are the non-negotiable acceptance criteria you’d require before scaling beyond a pilot?
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Outcome Discovery
Define target outcomes, measurable success signals (on-time collections/infusions, zero missed windows), and scalability requirements.
Discovery Questions
Setting the Table: A Quick Snapshot of Your Program
- Which stage best describes your program today?
- Roughly how many patients per month pass through the coordinated pathway today?
- Which therapy types are you coordinating right now? (select all that apply)
- Describe your current coordination model in one sentence (who owns scheduling, who escalates).
- Which systems are you currently using to track patient milestones?
The Stakes: What Happens When a Window Is Missed?
- If a single missed treatment window could cost a manufacturing slot or patient safety, how would that change how you prioritize coordination?
- How often do missed windows or manufacturing delays occur in your program?
- Which outcomes have you already observed when windows are missed? (select all that apply)
- Tell us about a specific recent case where a scheduling breakdown had significant downstream impact—what happened and why?
- How do these events typically affect stakeholder confidence (internal teams, sites, patients)?
What’s Quietly Breaking — The Real Failure Modes
- What recurring operational failure do teams act like is 'normal' but actually causes the most risk?
- Which of these failure modes occur most often in your workflow? (select all that apply)
- When one of those failure modes happens, how do you discover it first?
- How long does it typically take to detect and resolve a failure mode from first sign to resolution?
- In your experience, what’s the single root cause that, if fixed, would eliminate the most downstream failures?
Metrics That Matter — What You’d Put on the Dashboard
- Would you trade a small improvement in 'on-time' metrics for a big reduction in patient stress? Why or why not?
- Which success signals should we track to prove value? (pick up to 5)
- What are your current baselines for the top 3 KPIs you care about?
- What thresholds would make you comfortable calling the program a success?
- How frequently do you need reporting to feel confident—real-time, daily, weekly, or monthly?
If Volume Doubled Tomorrow: Where Would You Fall Over?
- If you had to double patient throughput in 90 days, what would break first and why?
- Which constraints limit scale today? (select all that apply)
- What coordinator-to-patient ratio do you consider safe for current clinical complexity?
- How quickly can you add new coordination headcount and get them fully productive?
- Describe any single-system or manual bottleneck that consistently constrains capacity.
Who's Accountable at Critical Moments?
- When a time-sensitive escalation occurs, who currently has authority to make binding changes (slots, travel, clinical schedule)?
- Do escalation paths include after-hours decision ownership? If so, who covers it?
- How clearly documented are decision rights and escalation timelines for each milestone (apheresis, lymphodepletion, infusion)?
- Share an example of a time escalation failed—what decision gap caused the issue?
- Which parties must sign off on acceptance tied to clinical milestones?
Patient Experience Signals We Shouldn’t Ignore
- When a patient walks away satisfied from a coordinated therapy journey, what emotion or experience did we deliver?
- What patient-facing channels work best for your population? (select all that apply)
- Which patient experience metrics do you currently capture?
- How do coordination failures affect patient anxiety and adherence in your programs?
- What expectations do patients and caregivers have for update frequency and clarity?
Trade-offs, Red Lines, and Non-Negotiables
- What would cause you to terminate a coordination partnership even if performance metrics improved?
- Which contractual or compliance items are absolute requirements? (select all that apply)
- How much pilot tolerance do you have for initial failure while processes stabilize?
- Describe any legal, commercial, or ethical constraints that would limit automation or escalation (e.g., patient consent, site policies).
- Are there internal stakeholders who will veto changes regardless of operational improvement? Who are they?
If Success Lived on a Scoreboard, What Three Numbers Matter?
- Pick the three metrics you'd want on your weekly dashboard (choose up to 3)
- What target value would represent an acceptable week for each chosen metric?
- Who in your organization will ultimately sign off that these targets are met?
- How would you prefer exceptions or near-misses to be surfaced—automated alerts, daily report, weekly review, or real-time phone escalation?
- What timeline feels realistic to reach your 'acceptable' targets (pilot duration to scale)?
Small Tests That Build Confidence — What Would You Pilot?
- What single experiment would you be willing to run in the next 30–90 days to test outcome improvements?
- What sample size and therapy complexity level would make a pilot meaningful for you?
- Which data feeds and integrations must be live for the pilot to be valid? (select all that apply)
- Who are the key stakeholders that must be engaged for a pilot to proceed (name roles)?
- What acceptance criteria would you use at pilot end to decide whether to expand?
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Solution Experience
Walk through patient- and site-level scenarios showing how coordinators, portal visibility, and escalation protocols prevent missed milestones.
Experience Meetings
- Current State Confirmation & Prework Review
- Consequence & Risk Quantification
- Patient-Level Scenario Walkthroughs (Diagnosis → Proof → Validation)
- Site-Level Workflow & Escalation Protocols
- Validation & Pilot Sign-off Workshop
- Legal/commercial to draft SLA language reflecting agreed response times for inclusion in the scope document.
- Sponsor to confirm financial assumptions and provide cost-per-incident inputs for modeling.
- Host to produce a one-page consequence summary linking failure modes to costs and risks.
- Operations to propose target success thresholds for on-time collections/infusions and share with stakeholders.
- One-sentence Future State
- Validate that coordinator interventions and portal alerts would prevent missed milestones in the provided patient scenarios.
- Confirm that each remediation step ties directly to the quantified consequences and success signals.
- Identify any gaps in SOPs, portal alerts, or escalation timing that require adjustment before pilot.
- Coordinators to produce a step-by-step SOP for each demonstrated scenario with exact timestamps and owner handoffs.
- Product team to provide interactive portal mockups with the specific alert thresholds and views used in the walkthrough.
- Clinical ops to confirm that the scenarios accurately reflect patient clinical constraints and approve described mitigations.
- Review Site Roles & SLAs
- Agree on a time-bound escalation tree with named owners and contact information.
- Confirm SLA targets for site responses and manufacturer integrations that align to success signals.
- Produce a runbook outline and communication templates for all site-level incidents.
- Operations to publish the escalation tree with named contacts, response times, and backup contacts.
- Introductions & Objectives
- Host to create the site communication runbook and share editable templates for sponsor review.
- Recap: Current State, Consequence, Future State
- Formal sign-off to proceed to a pilot/dry-run or a clear list of remaining conditions for sign-off.
- Finalized acceptance criteria and success signals to evaluate pilot outcomes.
- Assigned owners and scheduled dates for the pilot with required resources committed.
- Sponsor to provide written sign-off or a list of remaining sign-off conditions within 3 business days.
- Operations to schedule the dry-run pilot, notify selected sites, and publish the pilot runbook.
- Product to enable portal features and alert thresholds required for the pilot and provide access to pilot users.
- Coordinators to complete scenario SOPs and confirm training is scheduled before the pilot start.
- A single, validated one-sentence current state that all participants accept.
- All required artifacts (timelines, incidents, contacts) confirmed and owned by named participants.
- Failure modes and metrics to be used in the Solution Experience are finalized.
- Schedule and participants for scenario walkthrough meetings are agreed.
- Sponsor to deliver 3 redacted patient timelines and last 12 months of missed-milestone incidents (deadline: 3 business days).
- Clinical ops to assign site SMEs and populate the site contact matrix in the shared workspace.
- Host (coordination team) to prepare role-based portal screenshots and coordinator SOP draft for walkthroughs.
- Restate Agreed Current State
- Explicit, quantified consequences for each prioritized failure mode (time, cost, clinical risk).
- A ranked list of failure modes to be tested in the Solution Experience based on consequence.
- Clear, measurable success signals that define the desired future state.
- One-sentence Current State
- Historical Impact Review
- Review Learnings from Walkthroughs
- Walkthrough — Site Non-response Escalation
- Scenario 1 — Missed Pre-treatment Medication
- Validation Checkpoint 1
- Financial & Clinical Consequence Modeling
- Review Pre-work Deliverables
- Acceptance Criteria & Success Signals
- Walkthrough — Apheresis Slot Conflict & Manufacturer Integration
- Prioritize Failure Modes by Consequence
- Scenario 2 — Patient No-show Due to Travel
- Escalation Tree & Timing Drilldown
- Pilot Cohort & Schedule
- Confirm Failure Modes
- Authority, Decision Rights & Exceptions
- Agree Target Success Signals
- Data & Metrics Check
- Validation Checkpoint 2
- Decision & Sign-off
- Communication Runbook & Templates
- Finalize Walkthrough Participants & Roles
- Next Steps & Owners
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Solution Scope
Define included coordination services, responsibilities, integrations, SLAs, and verification criteria for each treatment milestone.
Scope Configuration
- Assign Dedicated Patient Coordinator
- Provision Patient Portal Access
- Book Apheresis and Infusion Appointments
- Reserve Patient Travel and Lodging
- Integrate Manufacturer Slot Booking Feed
- Real-Time Treatment Milestone Tracking
- Operate 24/7 Patient Clinical Hotline
- Provide Day-of-Treatment Onsite Support
- Execute Insurance Prior Authorization Submissions
- Coordinate Chain-of-Custody for Shipments
- Manage Pre-Treatment Medication and Supply Delivery
- Run Escalation Protocols for Treatment Conflicts
Scope Questions
Assign Dedicated Patient Coordinator
- What patient-to-coordinator ratio do you expect at launch?
- Should coordinators be permanently assigned to a patient or operate as a pooled team with handoffs?
- Which coordinator qualifications are required (select all that apply)?
- What language(s) must coordinators fluently support?
- Specify any additional coordinator responsibilities you require (open text).
- What hours and days should coordinators be reachable for routine coordination?
Provision Patient Portal Access
- Which user groups need portal access?
- Which portal features are required at go-live?
- Is single sign-on (SSO) or enterprise identity provider integration required?
- Are accessibility (ADA) or localization (multi-language) requirements mandatory?
- How should patient onboarding to the portal be handled?
- If multi-language or custom content is required, please list required languages and content types.
Book Apheresis and Infusion Appointments
- Approximately how many apheresis and infusion appointments do you anticipate per month?
- How geographically distributed are treatment sites?
- Do you require direct integration with site scheduling systems (e.g., EMR schedulers)?
- What level of appointment flexibility is acceptable for critical milestones (fixed windows vs flexible rescheduling)?
- What confirmation cadence and methods do you expect for appointments?
- Are after-hours or weekend appointment options required for apheresis/infusion?
Reserve Patient Travel and Lodging
- Which travel and lodging elements should we manage?
- What booking policy should we follow when balancing patient preference vs cost/approval?
- What typical travel scope applies (local same-city, domestic flights, international)?
- Do travel arrangements require pre-authorization or expense approval workflows?
- Are there preferred travel vendors, corporate travel management (TMC) or vendor integrations to use?
- Who is financially responsible for travel and lodging (sponsor, patient, insurer, hybrid)?
Integrate Manufacturer Slot Booking Feed
- Which technical feed types does the manufacturer support for slot booking?
- What frequency of slot updates is required?
- Which core data elements must be exchanged from the manufacturer?
- What authentication/network requirements must be supported (select all that apply)?
- Will a sandbox/test environment be provided by the manufacturer for integration testing?
- What is your target timeline to complete manufacturer feed integration?
Real-Time Treatment Milestone Tracking
- Which milestones must be tracked in real-time (select all that apply)?
- How should milestone updates be delivered to stakeholders?
- What SLA do you require for reflecting milestone status changes in the system?
- Which stakeholders must have visibility to milestone tracking?
- Do you require audit trails and exportable reports for milestones for regulatory review?
- What uptime or availability SLA do you require for the tracking system?
Operate 24/7 Patient Clinical Hotline
- Do you require a 24/7 clinical hotline or extended business-hours coverage?
- What languages must hotline staff support?
- What average monthly call volume do you anticipate to size staffing?
- Should the hotline provide clinical triage by licensed clinicians or scripted navigation by coordinators?
- Are automatic escalation rules required from hotline to sponsor/manufacturer/site for specific triggers?
- Do you require integration of hotline logs with EHR or sponsor case systems?
Provide Day-of-Treatment Onsite Support
- Which onsite roles do you require on day-of-treatment?
- For each site, how many day-of-treatment staff days do you expect per patient/event?
- Will onsite staff require site credentialing, EMR access, or badge issuance?
- Do you require a written onsite SOP and checklists to be followed by staff?
- Are travel, lodging and per-diem for onsite staff managed by sponsor or coordinator organization?
- Please describe any clinical tasks onsite staff must perform beyond coordination (e.g., sample handling, bedside support).
Execute Insurance Prior Authorization Submissions
- Do apheresis/infusion or related services typically require prior authorization for your patient population?
- Which payer types are most common for your patients?
- Do you require full prior auth submission handling including appeals and denials management?
- What turnaround expectations do you have for prior authorizations?
- Will we need access to payer portals or dedicated payer integrations to submit authorizations?
- Are there financial counseling or patient cost-sharing responsibilities you want included in the auth workflow?
Coordinate Chain-of-Custody for Shipments
- Which party currently owns chain-of-custody responsibilities?
- What types of biological materials will require chain-of-custody tracking?
- What cold-chain temperature classes are required for shipments?
- Do you require integration with carrier tracking or telematics for real-time location/temperature?
- Is there an existing SOP for failed pickups, delays, or temperature excursions that we must follow?
- List required shipment documentation and regulatory records for chain-of-custody (open text).
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Mutual Commit
Finalize commercial and legal terms, operational responsibilities, escalation ownership, and acceptance tied to clinical milestones.
Agreement Modules
- Non-Disclosure Agreement (NDA)
- Master Services Agreement (MSA)
- Statement of Work (SOW)
- Service Level Agreement (SLA) & Escalation Annex
- Pricing & Payment Schedule
- Data Processing Agreement / Business Associate Agreement (DPA/BAA)
- Operational Responsibility Matrix (RACI)
- Integration & Technical Onboarding Agreement
- Clinical Acceptance & Go/No-Go Sign-off
- Change Control / Variation Order
- Training & Enablement Sign-off
- Insurance, Liability & Indemnity Addendum
- Termination & Transition Plan
- Regulatory & Compliance Attestation
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Deployment
Operationalize rollout with readiness checks, enablement, and outcome validation.
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Pre-Deployment Readiness
Confirm data feeds, site access, coordinator assignments, manufacturer integrations, and contingency protocols are ready.
Readiness Questions
Quick Roll Call: A Two‑Minute Program Snapshot
- Which stage best describes your program right now?
- Roughly how many active patients per month are you managing through treatment timelines today?
- How geographically dispersed are the sites involved in a typical patient journey?
- Which core systems are you using today to track patient milestones?
- In one sentence, what outcome would make this program feel successful to you this quarter?
What’s at Stake When a Timeline Breaks (and Why It Hurts)
- If a single patient misses their treatment window tomorrow, what immediate operational and clinical consequences do you expect to see?
- How often do you experience a missed or at‑risk treatment window today?
- Which downstream consequences have actually occurred from those slips?
- When those events happen, how do they feel internally—operationally and emotionally—for your patients and team?
- How do you currently detect an at‑risk milestone before it becomes a missed window?
Tell Me About the Last Time It Fell Apart
- Think of the most recent patient who fell out of sequence—what single breakdown started the cascade?
- Which parties were directly involved in that failure?
- How long did it take your team to realize the patient was off‑track and begin remediation?
- What workaround or mitigation did you try, and did it resolve the issue?
- What would you say leadership learned from that event—were any policy or process changes tried?
Which Step Feels Like a Time Bomb?
- If you had to pick one milestone that you’re quietly most worried about, which is it and why would it derail a patient timeline?
- Walk me through the typical touchpoints for that milestone—who communicates, what systems are used, and what manual handoffs occur?
- What failure modes do you see there most often?
- How consistently do sites follow the SOPs you’ve provided for that step?
- Which site types or regions tend to cause the most friction?
Who Actually Pulls the Emergency Brake?
- When timelines slip, who ends up making the final call to change a patient plan—your team, the site, the manufacturer, or someone else?
- Do you have documented escalation paths and SLAs that sites and vendors acknowledge?
- Which roles should be notified first for an at‑risk milestone, and which actually get notified in practice?
- How often do you find escalation ownership blurred between sponsor, manufacturer and site?
- What communication channels do sites prefer for urgent escalations (select all that apply)?
If Zero Missed Windows Is the Goal, What Would You Need?
- Imagine we deliver zero missed windows for six months—what measurable signals would convince your stakeholders this is real?
- For your top two metrics above, what target values would be considered a success?
- How would your capacity and staffing needs change if volumes doubled from trial to commercial?
- Which internal groups must sign off that outcomes meet your definition of success?
- What short‑term patient experience indicators (beyond timelines) would matter to you?
If We Had One Week to Prove Readiness, What Would Break?
- What is the single biggest blocker today to standing up data feeds, site access and manufacturer integrations?
- Which integrations must be in place before go‑live (select all that apply)?
- Do sites typically provide technical endpoints (APIs/SFTP) or will we rely on manual file transfers and portal access?
- What contingency protocols do you already have documented for a missed collection or delayed manufacturing window?
- What coordinator model feels realistic for your scale—dedicated for each patient, pooled regional teams, or hybrid?
What Would a Low‑Risk Pilot Look Like to You?
- What’s the smallest pilot that would let you validate readiness without committing full resources?
- How quickly would you want a pilot to start once commercial and legal terms are acceptable?
- Which contractual or compliance gates must be closed before we can move to pilot?
- Who are the final approvers for a pilot and what single criterion would make them green‑light it?
- What are your biggest fears about running a pilot with an external coordination partner?
What Would Make You Comfortable Saying Yes?
- What evidence, in the form of data or proof points, would most reduce your perceived risk of working with a new coordination partner?
- If we delivered a readiness checklist that mapped to your internal approvals, who on your team would we need to involve to finalize that checklist?
- What timeline is acceptable for you to see measurable improvement after implementation?
- What would you want to see in a post‑pilot report to confidently transition from pilot to full deployment?
- Before we wrap, what single question have we not asked that would be important for your team to surface now?
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Deployment Enablement
Schedule rollout tasks, train coordinators and sites, enable the patient portal, and establish real-time milestone tracking.
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Validation Checklist
Run end-to-end dry-runs, verify timeline integrations and escalation paths, and confirm go/no-go acceptance criteria.
Validation Questions
Quick Snapshot: Where We Begin
- For this program, which best describes your current stage?
- Roughly how many patients per month do you expect to coordinate across treatment milestones in the next 12 months?
- Which therapeutic model describes your program?
- Who on your team will be the primary contact for operational coordination (role/title)?
- What would you most like us to understand about your program before we dig in?
When the Clock Starts Ticking
- What if a single missed appointment could derail a patient's therapy—how close has your program come to that?
- Walk me through the critical clinical windows in your treatment timeline (e.g., target apheresis date → lymphodepletion → infusion). Which are fixed vs. flexible?
- Who currently owns timeline confirmations for each milestone (manufacturer, sponsor, site, coordinator)?
- How do you currently surface and escalate a missed or at-risk milestone—what triggers an escalation and to whom?
- When a timeline slips, what are the most common downstream consequences you’ve seen?
- How stressful or emotionally taxing do these timeline risks feel for your clinical and patient-facing teams?
The Workflow Nobody Draws
- What processes do you think are documented—and where are you probably flying by the seat of your pants?
- List every system or tool currently used to track a patient’s progress (EMR, CTMS, EDC, manufacturer portals, spreadsheets, phone).
- How do handoffs look between each player (patient coordinator → site RN → manufacturer rep)? Describe a typical communication path and its weakest link.
- Which milestone handoff has historically required the most manual intervention or firefighting?
- How often do you perform an end-to-end walkthrough of the workflow with all parties involved?
- If I asked one front-line coordinator to draw the workflow on a whiteboard, what gap would we be most likely to uncover?
The Moments That Break Everything
- What single routine failure causes the most anxiety—no-shows, missed apheresis, site non-responsiveness, or something else?
- Tell a specific story of a recent failure: what happened, who noticed it, and what was the immediate outcome?
- How often do failures occur because of communication gaps versus system/data mismatches versus resourcing issues?
- When a critical failure occurs, how quickly are clinical leaders and the manufacturer notified and what does that notification look like?
- What have been the human costs—on patients and staff—when these moments happened?
- Which of these would you accept as an objective measure of system reliability: percentage of on-time infusions, missed-windows per 100 patients, or median time-to-escation? Select up to two.
If We Could Guarantee Zero Missed Windows
- Imagine you could remove one guarantee-breaking risk—what would you choose and why?
- What are the most important measurable success signals for your program (pick up to three)?
- How would your team and your leadership notice meaningful improvement—what dashboards or reports would change?
- What operational capacity or staffing change would you need to scale from current volume to your target volume?
- From a patient perspective, what outcomes or experiences would signal that coordination is world-class?
- What concerns would leadership raise if you proposed a program designed to hit these targets?
What Would Make a Partner Truly Trustworthy?
- What if every vendor promised fast escalation—what would make you still hesitate to hand off coordination?
- Which partner capabilities are non-negotiable for you (select all that apply)?
- How do you validate a coordinator's clinical judgment and ability to de-escalate a situation before it becomes a missed window?
- What SLA terms would meaningfully reduce your anxiety (response times, resolution times, notification windows)?
- Which verification artifacts would you require before accepting a partner operationally (runbooks, shadowing results, DR test reports)?
- Describe a past vendor relationship that felt reliable—what specific behaviors or structures made you trust them?
The Timing and Tech Reality Check
- If we said we could integrate timelines with your manufacturer and sites in 6 weeks, what would make you skeptical?
- Which data feeds are currently available or planned for integration (select all that apply)?
- What access barriers do we need to plan for (IT security review, contractual DPA, site IT approvals)?
- What would a successful end-to-end dry-run look like to you—what must happen and what would be a deal-breaker?
- Which metric would you use to accept a dry-run: % milestones simulated on-time, mean time-to-escalation, or zero intervention failures?
- Do you have sample data or pilot patients we could use for a dry-run? If yes, who owns it and how will we access it?
Commitment, Risks, and First Steps
- If implementing this coordination model exposed organizational gaps, who would need to be involved to close them quickly?
- What timeline for pilot → validate → scale feels realistic to you, and what's driving that timeline?
- What would you consider acceptable risk for a pilot (e.g., limited patient cohort, specific sites only, time-bound)?
- What are your top three concerns about engaging an external coordination partner right now?
- Who are the decision-makers and approvers for a partnership like this, and what does each person or group care about most?
- If we agreed on a pilot, what's the single earliest action you could commit to in the next 7 days to keep momentum?
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Success
Review outcomes against success signals, capture operational learnings, and maintain a shared channel for issues and improvements.
Success Reviews
- Outcomes Validation Review (Monthly)
- Operational Retrospective & Root Cause Analysis (Trigger-based / Monthly Deep Dive)
- Playbook & SOP Update Workshop
- Weekly Risk & Escalation Triage (Recurring)
- Executive Success & Scaling Review (Quarterly)
Issues & Enhancements
- Escalate items that cannot be resolved operationally to executive or manufacturer stakeholders.
- Stand up a short pilot or experiment to validate the highest-impact control.
- Update the incident register with RCA findings and share with stakeholders.
- Schedule a follow-up verification meeting on the agreed validation date.
- Review Proposed Revisions
- Finalize and approve operational playbook and SOP revisions that address documented failures.
- Assign clear owners for document updates, portal changes, and training delivery.
- Set a rollout schedule and acceptance criteria for the updated processes.
- Publish the revised playbook and SOPs to the shared repository with version control.
- Update portal text, checklists, and automation rules to reflect new SOPs.
- Schedule and deliver training to coordinators and site champions before the go-live date.
- Announce the changes to stakeholders via the shared channel and capture acknowledgements.
- Roll Call & Review Open Escalations
- Reduce the backlog of critical escalations and confirm immediate mitigations.
- Ensure every high-impact escalation has an owner and a defined timeline to resolution.
- Welcome & Objectives
- Close or update ticket statuses in the shared channel and notify impacted parties.
- Trigger vendor/manufacturer escalations for issues outside operational control.
- Document any temporary mitigations and plan for permanent fixes via the retrospective process.
- Executive Summary of Outcomes
- Obtain executive alignment on whether success signals justify renewal or scale decisions.
- Secure resource or budget commitments required to remediate capacity or integration gaps.
- Ensure executives understand patient-level consequences and strategic risks tied to operational performance.
- Produce an executive one-pager summarizing validated outcomes, risks, and recommended decisions.
- Draft a decision memo and obtain sign-off on renewal/scale and associated budget allocations.
- Initiate procurement or hiring plans to close approved capacity gaps.
- Schedule follow-up checkpoints to report on investment impact against agreed KPIs.
- Confirm whether the program met the defined success signals for the period with validated data.
- Identify and prioritize the top operational gaps causing missed milestones.
- Assign clear owners and timelines for corrective actions and re-validation steps.
- Ensure the shared issues channel has ownership, SLAs, and a monitoring cadence.
- Publish the validated monthly outcomes report with notes on any re-calculations or data corrections.
- Assign owners and due dates for the top 3 corrective actions identified in the session.
- Open tickets for data/integration fixes and schedule a triage with engineering within 48 hours.
- Update the shared channel roster and monitoring cadence document.
- Incident Recap & Timeline
- Identify the true root cause(s) for the incident and document contributing factors.
- Agree on a set of prioritized corrective controls and experiments with owners and timelines.
- Define measurable verification criteria and monitoring to ensure the fix is effective.
- Create and assign corrective action tickets with SLOs and expected verification dates.
- Success Signals Dashboard Review
- Priority Sorting & Reassignment
- Map Changes to Roles & SLAs
- Impact Assessment
- Patient & Clinical Impact Narrative
- Financial / Contractual Implications
- Update Escalation Flows & Responsibilities
- Data Validation & Anomalies
- Immediate Mitigations
- Root Cause Analysis (5-Whys / Fishbone)
- Scalability & Capacity Readiness
- Data & System Alerts Review
- Patient Case Spotlights
- Technology & Portal Content Alignment
- Preventive Controls & Experiments
- Training & Rollout Plan
- Strategic Risks & Mitigation Plan
- Escalation to Execs/Manufacturers
- Verification & Monitoring Plan
- Gap Analysis & Root Causes (high-level)