Starting snapshot, so we begin from the same page

• How often does your team run clinical studies that require external lab, imaging, ePRO, or safety integrations? Options: Multiple times a year, Once a year, Every few years, Rarely or never
• Tell me about the last study you closed, including phase, approximate patient count, and whether it supported a regulatory submission
• Walk me through who on your team is directly responsible for database lock, query resolution, and the final data handoff to statistics
• When was the last time an external data feed or edit-check issue pushed your database lock beyond the acceptable window, and what moved the date
• Which core deliverables do you worry about most when lock is under pressure, select up to three Options: CRF data completeness and consistency, Integrated lab reconciliation, SDTM and ADaM deliverables, Query closure and resolution, Medical coding accuracy, Audit trail and e-signature readiness

Where the current setup breaks down and why it matters

• If a vendor EDC and services team failed to deliver an analysis ready dataset on your critical path, which downstream activity would stop first and why
• Describe the most common site or form level data quality failure you see that creates long query cycles
• In your most recent study, how many open queries per subject at mid study would you label unacceptable Options: >10, 6 to 10, 3 to 5, <3, Not tracked
• Rate how much time and effort medical coding and repeated query rework currently consume for your team Options: Minimal impact, Some impact, Moderate impact, High impact, Critical drain on resources
• Tell me what escalation path you use today when a backlog threatens database lock and who gets pulled in first

Integration reality, the external data truth we need to plan for

• What single integration failure—ID mismatches, duplicate subjects, mismapped units, or missing metadata—would make the study unworkable for submission Options: Subject ID mismatches, Lab unit or assay mismatches, Missing imaging metadata, Unmapped ePRO visit windows, Other
• Which external sources are primary for this trial, choose all that apply Options: Central lab, Imaging core lab, ePRO vendor, Safety/Pharmacovigilance system, Randomization/IVRS, Other
• Walk me through your current process for reconciling lab and EDC subject IDs and share the typical failure rate you see
• Count how your integration endpoints are delivered today Options: All endpoints expose APIs, Mostly APIs with some file drops, Mostly file drops with some APIs, All file drops, Unknown
• Could you identify the named owner who can provide integration credentials and who will sign an SLA for each external vendor

Timeline pressure, what will break the schedule if left unaddressed

• What single timeline risk would force you to miss your target filing or database lock date
• When do you plan to begin study build relative to first patient in, for example before protocol activation or after first patient enrolled Options: Before first patient in, At first patient in, After first patient in, Build already started
• If UAT uncovers systemic edit-check failures needing redesign, how many business days do you consider acceptable to resolve them before the timeline slips Options: 0 to 5 business days, 6 to 10 business days, 11 to 20 business days, >20 business days, Unsure
• Who is enabled in your organization to approve a formal timeline change and reallocate budget or people to recover schedule
• List any fixed regulatory submission dates, inspection windows, or sponsor milestones that cannot move

People and capacity, who will do the work and where the bottlenecks are

• Who will be the single named owner responsible for negotiating acceptance criteria and signing off on database lock
• Are there internal teams or contractors already assigned to study build, edit-check programming, or query management Options: Internal data management team assigned, Contractors/consultants assigned, Hybrid internal and contractors, No teams currently assigned
• Describe your current effective headcount and bandwidth in data management during peak build and during ongoing maintenance
• Rank these responsibilities between your team and an external services partner as primary or secondary Options: Edit-check specification and programming, Query triage and escalation, UAT coordination and defect resolution, Data reconciliation and SDTM mapping, Medical coding and term review
• Identify any pending hires, budget approvals, or procurement milestones that must complete before vendor work can begin

What you are comparing this to, the alternatives on the table

• Why would you keep the incumbent or an internal solution rather than switching to an external platform and services partner
• Select the alternatives you are actively evaluating right now Options: Current incumbent vendor, Internal build or dedicated internal team, Other external vendors responding to RFP, Specialist integration partner, No alternative under active evaluation
• In your most recent vendor change, what single factor decided whether you switched or stayed
• Are there internal proposals to solve this without an outside vendor, for example by hiring more staff or buying point tools Options: Yes, internal build plan exists, Yes, hiring more staff is planned, No internal plan, Under discussion
• Would a stronger SLA and a named services team be enough for you to stay with the incumbent Options: Yes, likely, Maybe, No
• Name the top condition that would have to be true about your current approach for you to definitely keep it rather than change

Operational readiness and non negotiable constraints

• Identify the single operational constraint that, if unmet, would stop the engagement before the build begins
• Could you confirm whether each integration endpoint has a reachable technical contact and a documented SLA Options: All endpoints have contacts and SLAs, Some endpoints have contacts and SLAs, No, most endpoints lack documentation, Unknown
• Please list the team that owns regulatory approvals, legal reviews, or privacy sign off for this study and expected lead time
• Estimate how many systems have documented field mappings and data dictionaries you can share Options: 0, 1 to 3, 4 to 9, 10 or more, Unknown
• Provide the current access and security constraints the platform must meet, for example hosting region, encryption standards, or data residency rules

Acceptance criteria and next steps that move this forward

• Assuming the pilot demonstrates the promised reduction in unresolved queries and faster reconciliation, what would accelerate you to sign that week
• Provide your target decision window for signature after pilot completion Options: Immediately, Within 2 weeks, Within 30 days, 60 days or more, Unsure
• Select the acceptance criteria that must be met for you to sign Options: Target query closure rate achieved, SDTM and ADaM deliverables on schedule, UAT passed with no Priority 1 defects, Security and privacy review signed, Budget and PO issued
• Name the person who will approve contract signature and the best way to reach them
• Do you have mandatory legal terms, a data processing agreement, or indemnities that could delay signature Options: Yes, fully documented and provided, Yes, documented but not finalized, No mandatory terms, Not sure

• Solution Experience: Analysis-ready Database Workflows

• Confirm the current state and its cost to your timelines
• Customer confirms the demonstrated workflow eliminates the manual reconciliation and rework described in Discovery.
• Provide a tailored workflow diagram and a sample CRF-to-analysis mapping based on the buyer's delivered CRF extract and one lab file within four business days.
• Provide a representative CRF extract, one central lab file, the current edit-check specification, and your target database lock date before the follow-up session.
• Map your study context to end-to-end workflows
• Customer confirms the integration mapping supports delivery of analysis-ready datasets on the required timeline.
• Proof: CRF-to-analysis mapping with edit-check and query flow
• Customer agrees on the acceptance criteria and evidence required to start a scoped build and POC run.
• Schedule a sandbox proof-of-concept run using the supplied files and agree on success metrics for that run.
• Proof: Integration reconciliation across external sources
• Proposed operating cadence and SLAs to protect lock date
• Validate: Is this what you meant when you said you needed a single workflow that eliminates manual reconciliation and secures database lock?

• Solution Experience: Analysis-ready Database Workflows
• Solution Experience Deck
• Solution Brief — Analysis-ready Database Workflows

• meeting
• slides
• document

• Study Build and EDC Form Configuration
• Edit Check and Real-Time Validation Programming
• Site Interface Customization
• UAT Execution and Issue Remediation
• Data Entry Monitoring and Query Management
• Medical Coding and Term Mapping
• Central Lab Data Integration
• Imaging Data Integration
• ePRO and Device Data Integration
• Safety Data Reconciliation
• Cross-Source Data Reconciliation
• Analysis-Ready CDISC Dataset Delivery
• Database Lock Execution and Archive
• E-Signature and Audit Trail Enablement

Study Build and EDC Form Configuration

• List the CRF forms and electronic CRF pages required for this protocol by CRF name and visit.
• Provide the CDASH domains and any protocol-specific CRF variants that must be supported.
• How many unique visit windows and conditional visit flows (for example multiple windowed visits, unscheduled visits) must the EDC support? Options: None, 1-5, 6-20, 20+
• Identify the CRF fields that require complex derived calculations or automatic population (for example dosing calculations, delta from baseline) that the build must implement.
• Who will own final CRF specification sign-off (role names) and how will you document change requests during build?
• Do you require eSource data entry or intermediate imports (for example lab manual entry bypass, device direct-to-EDC) for any CRFs? Options: No, Yes - full eSource, Yes - partial import workflows

Edit Check and Real-Time Validation Programming

• Provide a prioritized list of key edit checks by CRF item (for example visit date vs randomization date, dosing vs weight) that must be implemented in real time.
• Specify the expected edit-check formats and traceability requirements (for example rule ID linked to CRF item ID, comment templates for sites).
• Estimate the number of cross-form and cross-source edit checks (for example checks comparing EDC fields to central lab or ePRO timestamps). Options: None, 1-50, 51-200, 200+
• Who will review and approve edit-check logic prior to inclusion in UAT (roles and responsibilities)? Options: You, We, Joint review
• Do you require real-time query generation at data entry or only batch validation runs for bulk reconciliation? Options: Real-time at data entry, Batch validation only, Both real-time and batch
• Specify any regulatory or inspection traceability needs for edit checks (for example mapping rule to audit trail entry, validation evidence).

Site Interface Customization

• Which site roles require custom entry views or dashboards (for example investigator, coordinator, research nurse)? Options: Investigator, Coordinator, Research nurse, Other
• List any site-facing workflows that must support offline entry or delayed synchronization (for example remote sites with intermittent connectivity).
• Do sites require language localization of CRFs and help text and, if yes, which languages are needed? Options: No, Yes - single language, Yes - multiple languages
• Specify field-level help text, protocol reference documents, or specimen collection instructions that must be surfaced in the site UI.
• Are there device or bandwidth constraints at sites that affect UI design (for example tablet-only entry, strict mobile support, offline-enabled tablets)? Options: No constraints, Low bandwidth sites, Tablet-only, Offline required
• Who will provide site training materials and job aids for data entry and query resolution? Options: You provide, We provide, Joint creation

UAT Execution and Issue Remediation

• List the UAT scripts or workflows you require executed and the CRFs or integrations they must validate.
• Provide the target test data approach for UAT: synthetic test data, anonymized production-like data, or a combination. Options: Synthetic test data, Anonymized real data, Combination of both
• Who are the named UAT owners and approvers from your team by role for test execution and final sign-off?
• State the defect acceptance threshold for UAT (for example no critical defects, fewer than five high-severity defects). Options: No critical defects, <=5 high-severity defects, Custom - will specify
• Do you require delivered automated regression test scripts as part of UAT handover? Options: Yes, No
• Which remediation turnaround SLA do you expect for confirmed UAT defects during the validation window (for example 24 hours, 48 hours)? Options: 24 hours, 48 hours, 5 business days, Custom

Data Entry Monitoring and Query Management

• Which query lifecycle stages do you expect the platform to manage (for example creation, triage, escalation, closure)? Options: Full lifecycle management, Creation and triage only, Triage only
• Estimate peak concurrent open queries for the study to size monitoring and analytics (for example <100, 100-500). Options: <100, 100-500, 500-2,000, 2000+
• Who will own first-line query resolution with sites for source clarification and who will own escalations? Options: You own, We own, Hybrid with escalation to you
• Do you require automated query reminders, SLA enforcement, and aging alerts for site responses? Options: Yes, No
• Specify any query aging thresholds or escalation windows that must trigger automatic escalation (for example unresolved after 5 days).
• Do you want management dashboards for query KPIs such as median time-to-first-response and closure rates? Options: Yes, No

Medical Coding and Term Mapping

• Which coding dictionaries must be supported for adverse events and concomitant medications (for example MedDRA, WHO Drug Dictionary)? Options: MedDRA, WHO Drug Dictionary, Other
• What level of coding automation is required: purely manual coding, auto-suggest with human review, or auto-assign with defined exception rules? Options: Manual coding, Auto-suggest with reviewer, Auto-assign with exceptions
• Estimate the volume of verbatim terms to be coded during the study (for example <500, 500-5,000). Options: <500, 500-5,000, 5,000-20,000, 20,000+
• Who will approve final coded terms for safety submissions and periodic review cycles? Options: You approve, We approve, Joint approval
• Do you require mapping of lab analyte names to LOINC codes as part of lab integration and dataset delivery? Options: Yes, No
• Provide current coded-data quality benchmarks you track (for example coding coverage percentage, reviewer audit sample rates).

Central Lab Data Integration

• Which central lab feed formats must be integrated (for example CSV flat files, HL7 v2 messages, or vendor API output)? Options: CSV/flat files, HL7 v2, Vendor API/JSON, Other
• Describe the matching keys and reconciliation rules to link lab results to EDC subject and visit (for example subject ID, specimen ID, visit code).
• How frequently will lab results be delivered and do you require support for incremental versus full-load deliveries? Options: Real-time/incremental, Daily batch, Weekly batch, Ad hoc
• Who will own mapping of lab analytes to CRF fields and SDTM variables during build and review? Options: You, We, Joint
• Are there special lab processing rules we must apply (for example multiple reference ranges, flag logic, or delta calculations)?
• What acceptance criteria will confirm a successful central lab integration (for example reconciliation match rate target, successful incremental load test)?

Imaging Data Integration

• Which imaging modalities and DICOM services are in scope (for example CT, MRI, DICOM Study/Series UID mapping)?
• How should imaging metadata map to CRF fields and analysis datasets (for example accession number to CRF imaging date, series date to analysis variable)?
• Do you require viewer integration, anonymization pipelines, or first-image-load performance SLAs for remote reads? Options: Viewer integration, Anonymization pipeline, Performance SLA, None
• Which file transfer methods are acceptable for image delivery (for example SFTP, DICOMweb, vendor API)? Options: SFTP, DICOMweb, Vendor API, Other
• Who will validate imaging metadata mapping and approve image set inclusion for analysis or central reads? Options: You, We, Joint
• Specify any regulatory constraints for imaging storage, retention, or redaction that we must implement (for example years of retention, redaction rules).

ePRO and Device Data Integration

• List the ePRO vendors and device endpoints to be integrated and the native delivery formats they provide (for example JSON API, CSV export).
• Describe how ePRO events should map to scheduled visits and CRF timestamps, including handling of unscheduled or late assessments.
• Do you require device telemetry cleansing, sampling rules, or generation of derived variables (for example daily averages, peak values)? Options: Yes, No
• How should offline capture and delayed sync be handled when devices reconnect (for example conflict resolution, timestamp precedence)?
• Who will manage subject consent and identifier linkage for device and ePRO identifiers to ensure deterministic matching to EDC subjects? Options: You, We, Joint
• What acceptance criteria will confirm successful end-to-end ePRO/device integration before the build moves to production (for example end-to-end sync of a test subject, event-to-visit mapping validation)?

Safety Data Reconciliation

• Which safety feeds must be reconciled with the EDC SAE pages (for example pharmacovigilance database exports, expedited safety feeds)?
• What SLA do you require for reconciliation turnaround and duplicate detection between safety endpoints? Options: 24 hours, 48 hours, 5 business days, Custom
• How should SAE narratives, investigator reports, and source documents be linked to EDC records for inspection readiness?
• Who will own final SAE reconciliation and expedited reporting sign-off for regulatory submissions? Options: You, We, Joint
• Do you require automated detection of potential unreported SAEs based on signals from lab results or concomitant medication entries? Options: Yes, No
• Provide any regulatory reporting templates or expedited-report thresholds that must be supported (for example 7-day serious unexpected suspected adverse reaction criteria).

• Master Services Agreement (MSA)
• Statement of Work (SOW)
• Subscription Agreement & Order Form
• Service Level Agreement (SLA)
• Data Processing Agreement (DPA)
• HIPAA Business Associate Addendum (BAA)
• Resourcing & Timeline Confirmation
• Acceptance Criteria & Sign-off
• Change Order Agreement
• Payment Schedule & Invoice Terms
• Termination & Transition Agreement

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

• Schedule an expedited checkpoint if any core outcome metric falls outside the agreed tolerance band before the next quarterly review.
• Schedule a short verification call to confirm remediation completions two business days before the acceptance gate.
• Restate acceptance criteria and numeric targets
• Each acceptance criterion recorded in Study Scope & Deliverables is marked pass or fail and documented in the shared workspace.
• A formal acceptance decision is captured with the named signatory or equivalent documented owner decision.
• Remediation plan and verification date established for any failed criteria.
• Publish the signed acceptance record and the pass/fail table to the shared workspace.
• Create remediation tickets for any failed criteria with owners and target resolution dates, and schedule verification checkpoints.
• If incumbent is being retired, document the decommission plan, archive status of migrated data, and confirmation that no active work remains in the old system.
• Review core outcome metrics
• Confirm whether percent of planned integrations successfully delivering data and open query backlog count remain within acceptable variance of targets recorded in Study Scope & Deliverables.
• Burn down the top persistent operational blockers or confirm a plan and owners to resolve them in the next quarter.
• Ensure enhancement requests and high-impact issues are prioritized and assigned with agreed delivery windows.
• Update the enhancement request log with priorities, owners, and target delivery dates and share the summary.
• Close resolved issues in the shared workspace and notify affected stakeholders.
• Re-confirm acceptance criteria and owners
• All acceptance criteria recorded in Study Scope & Deliverables have a confirmed owner and a plan for measurement.
• Production and integration environments validated or have agreed remediation with owners and dates.
• Critical blockers documented with remediation actions and verification dates.
• Publish the environment and integration validation checklist with pass/fail results to the shared workspace.
• Update the defect tracker with owners and target resolution dates for all critical items.
• Circulate a short user onboarding action plan to address any adoption gaps identified.
• Present first outcomes against named metrics
• Determine which named metrics are on-track versus off-track against targets recorded in Study Scope & Deliverables.
• Assign owners and dates to corrective actions required to bring off-track metrics to target.
• Agree the revised timeline, if any, to reach the acceptance gate.
• Publish the metric snapshots and root-cause notes to the shared workspace with owners and deadlines for each remediation item.
• Open targeted work items to resolve the top integration errors and clear the largest aged queries within the agreed timebox.
• Present outcome data against each criterion
• Persistent blocker burn-down
• Deployment and environment validation
• Root-cause analysis for off-track metrics
• Document pass or fail per criterion
• Early adoption and usage signals
• Enhancement and issue-log review
• Agree corrective actions and owners
• Open defects and blockers triage
• Short status and action summary
• Formal acceptance decision and signatory capture
• Confirm timeline to the acceptance gate
• Agree immediate remediation actions
• Remediation plan for any failed criteria
• Incumbent system wind-down check (if replacing an incumbent)