How enrollment currently shows up for you

• How many open interventional studies is your team managing right now? Options: 1-4, 5-10, 11-25, More than 25
• Describe your typical enrollment target per site and the time window you are held to.
• When a site misses forecast, who on your team is first to flag the issue? Options: Project manager, Clinical operations director, Study monitor, Site lead, Other
• Which data points do you track each week to judge whether a site is on track? Options: Screening rate, Randomization rate, Pre-screen volume, Open queries, Regulatory milestones, Coordinator availability, Other
• How would you rate your current forecast accuracy versus actual enrollment over the past 12 months? Options: Within 10%, 10 to 25%, 25 to 50%, More than 50%, Unknown
• State the enrollment shortfall percentage per site that would make you stop considering new external partners. Options: Less than 25%, 25 to 50%, More than 50%, No fixed threshold, depends on context

Where enrollment promises tend to break

• What single forecasting failure would make you walk away immediately?
• Walk me through the last time a principal investigator overcommitted to enrollment, what happened next, and who absorbed the fallout.
• How often do coordinator turnovers delay data lock or increase query volume in your studies? Options: Almost every study, Often, Sometimes, Rarely, Never
• Which process step tends to add the most startup delay, regulatory clearance, contracting, or staff training? Options: Regulatory approvals, Contracting, PI availability, Site staff training, Budget negotiations, Other
• If one site delivered only 40% of its projected enrollment, what immediate operational changes would you expect the seller to implement?

Constraints that will stop a rollout cold

• Name a regulatory or contracting gate that, if missing, would cause you to pause activating any site.
• Who owns API or EHR connectivity at your organization, and will that owner be available for integrations in the next 8 weeks? Options: Internal IT, Clinical systems team, Third-party vendor, No owner yet, Unsure
• How ready is the patient recruitment data you would share, is it clean and accessible for targeting? Options: Ready and accessible, Partially ready, needs cleaning, Poor quality and needs major work, Not available
• Select the role expected to own study startup coordination at your organization. Options: Study project manager, Clinical operations leader, Site manager, Vendor program manager, Not yet assigned
• Are there any regulatory submissions or audits coming that could interfere with your target activation window? Options: Major filings in next 3 months, Minor activities in next 3 months, No known activities, Unsure

Alternatives you're weighing and why

• List the other provider types or approaches you are evaluating, for example incumbent CROs, internal expansion, or recruitment-only vendors. Options: Incumbent CRO, Internal site expansion, Independent investigators, Recruitment-only vendor, Hybrid site network, No alternatives identified
• What would have to be true about your current approach for you to keep it instead of moving to an outside partner?
• Identify any internal groups proposing a do-it-yourself build and summarize their main rationale.
• Select the description that best matches how you currently run investigative sites. Options: In-house site network, Single contracted CRO, Per-study site selection, Ad hoc investigator selection, No consistent approach

The hard numbers that would prove a partner can deliver

• If a 3-site pilot hit one clear metric, which outcome would make you sign a broader agreement that week?
• Which retention threshold best matches your expectation for clinical research coordinators? Options: Average retention >24 months, Average retention 12 to 24 months, Average retention 6 to 12 months, No specific retention target
• Choose the enrollment cadence you target per site in months 1 to 3. Options: 0 to 1 per month, 2 to 4 per month, 5 to 8 per month, Depends on indication
• Describe the regulatory milestones you require per site before first consent and the timeline you consider acceptable.
• What single legal or compliance concern would make you refuse to engage regardless of the partner's performance data?

Where startup usually gets held up

• Where in your startup timeline do weeks pile on most often, regulatory, contracting, PI onboarding, or site training?
• Walk me through the last site that took longer than planned to activate, what caused the delay, and who expedited resolution.
• Pick the contracting model you prefer for sites. Options: Master services agreement, Per-site budget, Central CRO contracting, Hybrid model
• How many full-time equivalent coordinator roles do you expect per active site for typical Phase II or III studies? Options: 0.25 FTE, 0.5 FTE, 1.0 FTE, 1.5+ FTE
• Explain who would push back and why if a 6-week regulatory and contracting startup was requested.
• Point to the one startup dependency that, if missing, would force you to delay launch.

Risk radar, what would stop the program

• Identify the site-level risk that would trigger an immediate stop to enrollment at that site.
• Tell me which data-quality metric you watch most closely as an early warning sign and why.
• How often have monitoring visits uncovered systemic issues versus isolated mistakes in your prior trials? Options: Mostly systemic, About half systemic, Mostly isolated, Rarely systemic, Unknown
• Select the consequence you would require if a pilot missed its enrollment SLA. Options: Terminate contract, Remedial plan with financial penalty, Extend pilot with agreed fixes, Operational review only, no penalty

Decision tempo and internal blockers

• Assuming a 3-site proof hits targets, list the approvals and decision gates that must clear before you can sign.
• How quickly does your procurement or legal team typically turn around contract redlines? Options: Less than 1 week, 1 to 2 weeks, 2 to 4 weeks, More than 4 weeks
• Pick the timeline that best matches your preferred contracting cadence after a successful pilot. Options: Sign within 2 weeks, 2 to 4 weeks, 1 to 2 months, Longer than 2 months
• Name any budget or governance constraint that would immediately remove this opportunity from consideration.
• What would happen internally if this partnership reduced your time to first patient by 50 percent?

• Site Performance Experience

• Confirm the current state and what it is costing you
• You confirm the demonstrated enrollment forecast materially reduces expected shortfall versus historical independent sites.
• Run the sample enrollment forecast using the provided protocol and deliver the forecast with variance analysis before the follow-up session.
• You confirm the demonstrated regulatory timelines address the bottlenecks that have delayed your past site activations.
• Agree study inputs for a live forecast
• Provide final protocol, target enrollment per site, geographic priorities, and any prior site performance reports to enable the forecast and timelines.
• Prepare a per-site regulatory start-up timeline and required document checklist tailored to the provided study.
• You confirm the data-quality controls reduce query volume and monitoring burden to acceptable levels for this protocol.
• Prove predictable enrollment with your study data
• Demonstrate accelerated regulatory start-up in this study context
• Agreement on the remaining evidence and next deliverables required before a commercial decision.
• Identify your internal decision makers and the timeline for selecting sites so next steps can be aligned to your cadence.
• Show data-quality controls and monitoring impact
• Validate fit and remaining evidence

• Site Performance Experience
• Site Performance Experience Deck
• Site Performance Solution Brief

• meeting
• slides
• document

• Provide Dedicated Principal Investigator
• Deploy Trained Clinical Research Coordinators
• Manage Regulatory Document Collection and Trial Master File
• Submit IRB/EC Applications and Track Approvals
• Execute Targeted Patient Recruitment Campaigns
• Manage Patient Screening and Enrollment
• Conduct Protocol-Compliant Study Visits
• Perform Source Document Management and eSource Entry
• Execute Data Query Resolution and Query Responses
• Prepare Site for Monitoring Visits and Source Verification
• Deliver Site Staff Protocol and GCP Training
• Provide Enrollment Forecasts Based on Historical Performance
• Deliver Centralized Quality Audits and CAPA Implementation
• Provide Patient Retention Programs and Follow-up Outreach

Provide Dedicated Principal Investigator

• Do you require a dedicated principal investigator (PI) committed only to this protocol for the study duration? Options: Yes, No
• How many PI full-time equivalent (FTE) hours per week must the PI commit to this protocol? Options: <5, 5-10, 10-20, 20+
• List the licensing and credential documents we must collect for the PI (for example: current medical license, curriculum vitae, human subjects protection training certificate).
• What acceptance criteria will confirm the PI is approved for site start (for example: signed delegation log, current CV on file, medical license verified)?
• Provide the name and contact for the internal approver who will confirm PI conflicts of interest and availability.
• By when must the PI be available on-site relative to first patient in (FPI)? Options: Within 1 week of contract signature, Within 2 weeks, Within 4 weeks, Custom date

Deploy Trained Clinical Research Coordinators

• Do you require coordinators with prior experience in this therapeutic area and phase (for example oncology Phase II, cardiology Phase III)? Options: Yes, No
• How many coordinator FTE per site are needed to support the protocol visit cadence and enrollment targets? Options: 0.5, 1, 1.5, 2+
• Which training records must be on file before site activation (for example ICH-GCP certificate, protocol-specific training, safety reporting training)? Options: ICH-GCP, Protocol-specific training, Safety reporting training, Other
• What objective acceptance criteria will validate coordinator readiness (for example: protocol quiz >=80%, completed delegation log, uploaded training certificates)?
• Who will own backup coordinator coverage for planned leave or turnover at the site? Options: Site staffing pool, Central operations team, Shared responsibility
• Describe any local hiring constraints or credential requirements for coordinators (for example license reciprocity, background checks, language fluency).

Manage Regulatory Document Collection and Trial Master File

• List the documents that must be included in the site-level Trial Master File (TMF) (for example: signed protocol, current ICF version, delegation log, safety reporting plan).
• Are there region-specific regulatory dossiers or local-language translations we must include (for example local lab certificates, translated ICFs)? Options: Yes, No
• When do you require the completed site regulatory binder/TMF to be delivered relative to FPI? Options: Before FPI, Within 7 days of FPI, Within 30 days of FPI
• Who will provide final signed copies of essential documents such as the executed protocol, contract, and approved ICF?
• Describe any eTMF system or TMF metadata requirements we must support (include system name and required document tags if known).
• Are copies of investigator medical license and research training required in the TMF prior to monitoring? Options: Yes, No

Submit IRB/EC Applications and Track Approvals

• List the IRB/EC submission types required for the study (for example central IRB, local IRB per site, country-specific EC). Options: Central IRB, Local IRB per site, Country EC, Other
• Should we prepare the full submission package (CVs, ICF, protocol, recruitment materials) or will you provide portions of the package? Options: We should prepare full package, Prepare partial package, Sponsor will provide package
• Estimate the expected number of IRB/EC query rounds during review. Options: 0, 1-2, 3+
• By what target timeline do you need IRB/EC approval measured from submission (for example within 30 days)? Options: Within 30 days, 30-60 days, 60+ days
• Provide the contact details of the authorized signatory for IRB submissions and for subsequent IRB responses.
• Should IRB/EC approval letters be uploaded to the TMF within 48 hours of receipt? Options: Yes, No

Execute Targeted Patient Recruitment Campaigns

• Select the recruitment channels we should deploy for this protocol (patient registries, referral networks, digital ads, primary care outreach, community outreach). Options: Patient registries, Referral networks, Digital advertising, Primary care outreach, Community outreach
• Estimate the expected monthly screen-fail rate we should assume for campaign modeling. Options: <10%, 10-25%, 25-50%, 50%+
• Must recruitment materials be pre-approved by your medical affairs or legal teams before fielding? Options: Yes, No
• Who will own lead triage and the CRM where recruitment responses must be pushed (provide CRM name and contact if available)?
• Describe any exclusion criteria that will materially affect the recruitment funnel (for example prior therapies, lab thresholds, concomitant conditions).
• Indicate required language translations and accessibility needs for recruitment materials and consent (for example Spanish ICF, large-print brochures).

Manage Patient Screening and Enrollment

• How many screening slots per week per site are required to meet the enrollment schedule? Options: 1-2, 3-5, 6+
• Who will authorize final eligibility determinations for borderline cases (site PI or sponsor medical monitor)? Options: Site PI, Sponsor medical monitor, Other
• Do you require use of a screening log with real-time entry into the EDC or is a site enrollment tracking spreadsheet acceptable? Options: EDC entry required, Site spreadsheet acceptable, Both
• What source documents should be used to verify inclusion/exclusion criteria (for example lab reports, ECG tracings, imaging reports)?
• Are pre-screening questionnaires via eConsent acceptable, or must initial contact be by telephone? Options: eConsent pre-screen allowed, Phone-only initial contact
• When should a subject be marked as enrolled in the EDC relative to consent, randomization, and first dose? Options: At consent, At randomization, At first dose

Conduct Protocol-Compliant Study Visits

• List the visit-specific SOPs coordinators must follow for study visits (for example vital signs SOP, ECG SOP, blood draw and sample handling SOP).
• Should visit checklists be tied to the EDC visit forms for verification? Options: Yes, No
• Indicate the reporting timeframe required for protocol deviations arising during visits. Options: Within 24 hours, Within 48 hours, Within 72 hours
• Who approves protocol deviation management plans and corrective actions (site PI, sponsor QA, other)? Options: Site PI, Sponsor QA, Other
• Describe any on-site sample processing or shipping requirements we must follow (for example centrifuge temperature, cold chain packaging, courier pickup windows).
• Which approach to source data verification (SDV) do you require for critical endpoints (remote SDV, in-person SDV, hybrid)? Options: Remote SDV, In-person SDV, Hybrid

Perform Source Document Management and eSource Entry

• Provide the eSource or EDC system name that will be used and any account provisioning requirements.
• Should we provide source document templates for visit notes and lab result capture? Options: Yes, No
• How will signature capture be handled for source documents (wet signatures, electronic signatures with audit trail, eConsent signatures)? Options: Wet signatures, Electronic signatures (audit trail), eConsent system
• Who will maintain the delegation of duties log and ensure it is current in the TMF? Options: Site coordinator, Central operations, Shared responsibility
• What turnaround time do you expect for eSource entry after a visit? Options: Within 24 hours, Within 48 hours, Within 7 days
• Are scanned source documents acceptable for monitoring review or do you require native electronic instrument feeds (for example lab instrument CSVs, imaging DICOM exports)? Options: Scanned documents acceptable, Native instrument feeds required

Execute Data Query Resolution and Query Responses

• What service-level agreement (SLA) should apply for query responses in the EDC (for example response within 3 business days)? Options: 1 business day, 3 business days, 5 business days
• Who is authorized to answer data queries for critical data points (for example PI sign-off required, coordinator can respond)? Options: PI sign-off required, Coordinator can respond, Sponsor data manager
• Should a documented quality control review occur before query responses are submitted into the EDC? Options: Yes, No
• Indicate which query types must be escalated to the sponsor (for example adverse event coding disputes, endpoint discrepancies).
• Describe the preferred method for bulk query resolution tracking (for example EDC workbench, sponsor ticketing system, shared spreadsheet).
• How should resolved query evidence be documented for monitoring review (for example annotated source pages, corrected eCRF screenshots)?

Prepare Site for Monitoring Visits and Source Verification

• Select the types and expected frequency of monitoring visits required (initiation, interim every X weeks, close-out). Options: Initiation and periodic interim, Remote interim, Close-out, Custom schedule
• Should we provide remote access to eSource or redacted source documents for pre-visit review? Options: Yes, No
• List the checklist items that must be verified at monitoring visits (for example consent documents, drug accountability, safety logs).
• Who will be the primary scheduling contact for monitoring visits and the person providing access to source files?
• By what timeframe do you require follow-up responses to CAPAs identified during monitoring visits? Options: 7 days, 14 days, 30 days
• Would you like a mock monitoring visit conducted before the sponsor's first monitoring visit? Options: Yes, No

• Master Services Agreement (MSA)
• Statement of Work (SOW)
• Site Performance and SLA Addendum
• Commercial Schedule and Order Form
• Project Timeline and Dependencies Schedule
• Data Processing Agreement (DPA) / HIPAA Business Associate Addendum (BAA)
• Change Order Agreement

• Go-live Health Check (weeks 1-4)
• First Outcome Measurement (weeks 4-10)
• Acceptance Gate Review (around day 90)
• Quarterly Success Review (ongoing)

• Update the shared issue channel with the quarter's closed items and list of escalated risks for executive visibility.
• Update the shared issue channel with prioritization and expected impact on overall enrollment forecast.
• Restate Solution Scope acceptance criteria and numeric targets
• Produce a documented pass/fail result for each acceptance criterion recorded in Solution Scope.
• Capture the buyer's formal acceptance decision with the named signatory or documented approver.
• When criteria are unmet, agree a remediation plan with clear milestones and a deadline for re-evaluation.
• Publish the acceptance decision, including evidence, pass/fail status per criterion, and the captured signatory or approver record.
• For any failed or conditional items, document the remediation plan with concrete milestones and expected completion dates.
• Update the project timeline and shared issue channel to reflect acceptance status and next checkpoints.
• Trend review of primary outcomes
• Confirm whether cumulative enrollment and data quality metrics are tracking to the Solution Scope forecasts, and document any deviations requiring action.
• Ensure coordinator retention and staffing risks are addressed with concrete retention or backfill actions.
• Close resolved issues, escalate persistent blockers, and agree measurable checkpoints for the next quarter.
• Produce a quarterly performance digest showing enrollment vs Solution Scope forecasts and data query rate trends for distribution to the shared workspace.
• Create and track a short-term mitigation plan for any sites driving the largest enrollment or data-quality variance, with milestones and expected metric improvements.
• Re-confirm scope, success criteria, and owners
• All sites have a documented activation status and any deviations from plan are captured with owners and target dates.
• Critical blockers that would prevent enrollment are identified and a remediation plan with target dates is agreed.
• Deployment gaps requiring follow-up are prioritized and scheduled for the next measurement review.
• Publish an updated per-site activation and blocker log with owners and target dates.
• Collect and circulate early operational signals (screening counts, system access logs) for sites flagged as at-risk.
• Schedule focused remediation sessions for any site missing regulatory or training prerequisites before the next measurement meeting.
• Present first outcome data against Solution Scope targets
• Determine whether enrolled participants are tracking toward the forecast recorded in Solution Scope and document site-level deviations.
• Identify the primary root causes for performance gaps, including staffing or regulatory blockers, and agree corrective actions with deadlines.
• Confirm a timeline to the acceptance gate and the data each site must produce to demonstrate improvement.
• Produce a per-site remediation plan addressing recruitment, coordinator staffing, or regulatory gaps with target completion dates.
• Collect and deliver the supporting data (screening funnel, outreach counts, regulatory document status) for each underperforming site before the acceptance gate.
• Present outcome data against each acceptance criterion
• Staffing and retention health
• Deployment verification
• Diagnose gaps and root causes
• Document pass/fail decision per criterion
• Early adoption and operational signals
• Regulatory and milestone status
• Regulatory milestone and startup speed review
• Open issues and critical blockers
• Agree corrective actions and timelines
• Open issue burn-down and risk register
• Formal acceptance decision and signatory capture
• Agree immediate remediation actions
• If required, agree remediation plan with timelines
• Agree next quarter actions and measurable checkpoints