Study Planning
Version the protocol-driven plan, country dependencies, site milestones and responsibilities. Keep targets separate from recorded decisions.
Move the trial forward. Know what is still missing.
Connect each study milestone to the evidence behind it. Ask neil to assess site readiness, prepare monitoring work and follow through on open obligations.
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You:
We plan to activate three sites on Friday. Which are actually ready, and what needs chasing?
neil
Site 101 has evidence for all four checks in the activation plan. Site 205 is missing amendment-training evidence. Site 309 has a dispatch record, but no pharmacy receipt acknowledgement. I would not treat those as three ready sites.
DocumentsTrainingInitiationReceipt
Site 101✓Documents: evidenced✓Training: evidenced✓Initiation: evidenced✓Receipt: evidencedReady for activation review
Site 205✓Documents: evidenced—Training: evidence missing✓Initiation: evidenced✓Receipt: evidencedTraining evidence missing
Site 309✓Documents: evidenced✓Training: evidenced✓Initiation: evidenced—Receipt: evidence missingReceipt acknowledgement missing
Checks from this site plan. The activation decision is still separate.
One site can go to activation review. Two need specific evidence before the same review can proceed.
About this example
A prepared conversation using fictional records, not a live query. Source buttons open the example evidence. The draft can be read and downloaded; no records are changed, shared or approved.
Connect the plan to what has happened.
A milestone date tells you the intention. The document, visit, receipt or decision tells you whether the work supports it. Seal connects those records at study, country and site level.
Keep your CTMS and eTMF where they are, or configure the operational workflow in Seal. Scoped connections can bring in enrollment, essential-document status and partner deliverables. Retain the source update time so yesterday’s export cannot quietly become today’s assertion of readiness.
Give the monitor a useful next step.
Ask neil to prepare the visit brief, compare it with previous findings and draft the follow-up. The useful output is a specific action with its evidence—not another red status on a dashboard.
Connect monitoring findings, site responses and sponsor review. Link payment milestones to the agreed contract and accepted evidence, rather than assuming a visit in EDC is automatically payable. Keep CRO deliverables and sponsor decisions together without blurring their responsibilities.
Finish the obligations, not just the visit.
Use the same connected work at closeout: unresolved findings, missing essential documents, supply accountability and outstanding payments remain inspectable after the last visit.
For a first implementation, follow one site from activation through a monitoring finding to closeout. Test late evidence, conditional decisions and a changed protocol version. The workflow should preserve what was known when each decision was made, and who still has work to do.
Explore the configured capabilities
Site Management
Connect feasibility, qualification, activation requirements and closeout obligations to their evidence.
Enrollment Tracking
Compare sourced enrollment counts with the agreed plan. Preserve the cutoff and denominator before interpreting changes.
Monitoring Visits
Prepare the visit from prior findings and current evidence. Link observations, site responses and reviewer decisions.
Trial Master File
Connect expected documents to the site and event that require them. Filing, completeness and approval remain separate checks.
Explore this blueprintClinical Quality
Carry a site issue into assessment and owned follow-up without losing its original observation or protocol context.
Explore this blueprintPayment milestones
Compare claimed milestones with the contract version and accepted supporting records before payment review.
Explore the connected records
Questions worth asking.
Yes, through agreed connections or selected exports. Scope the source records, identifiers, permissions and update frequency. You can begin with one cross-system review without moving the whole trial.
CTMS manages operational plans, sites, visits, milestones and follow-up. EDC holds case-report data and cleaning activity; eTMF holds essential documents. Link the relevant records while preserving each source’s role and version.
neil can assess the available evidence against the selected plan and prepare follow-up work. The authorised study team records the activation decision. A target date, a completed checklist or this example conversation does not activate a site.
Connect delegated scope, expected CRO deliverables, findings, sponsor reviews and outstanding actions. Keep the responsible sponsor role and the evidence for each decision visible alongside the partner’s work.
Configure the monitoring plan around the study’s critical data and processes. Use permitted site signals and prior findings to inform a reviewed visit plan. A query count or age alone is not a clinical risk score.
Link payment milestones to the applicable agreement and accepted evidence. Keep unresolved findings, supply accountability, documents and remaining obligations visible through closeout instead of treating the last visit as proof that everything is finished.
Continue into the connected work.
CTS
Clinical Supply Management Software
Protocol demand, kit and label design, packaging, randomization identifiers, depot and site inventory, temperature, returns, and reconciliation.
EM
Pharmaceutical Environmental Monitoring Software
Connect the sampling point, original count and actual operation. Use neil to investigate signals, prepare follow-up work and configure a monitoring program your team can review.
Data Integrity
Pharmaceutical Data Integrity & Audit Trail Review Software
Define the regulated record universe, schedule risk-based audit trail review, reconstruct changes in context, investigate anomalous activity, and prove that every GxP decision used complete and trustworthy evidence.
PV
Pharmaceutical Process Validation & PPQ Software
Coordinate process validation in Seal, from the agreed validation basis and PPQ protocol to execution, exceptions and review. Trace each conclusion to the evidence that supports it.
Bring the milestone that keeps slipping.
Tell us about the output your team needs. We’ll show you the workflow and discuss the records and connections it would use.
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