Clinical operations software.

Bring the whole trial into the review.

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Illustration of a seal beside a sample transport case and study records.

Summary

The problem
Preparing a study review means pulling EDC data, safety reconciliation, coding and study documents together, and it is hard to show which records were checked and which were unavailable.
Seal’s approach
Trial data, safety records and documents are connected through scoped connections or exports. Neil can prepare a review brief with source references, evidence gaps and proposed follow-up for the study team to verify.
What changes
Proposed queries and follow-up remain distinct from issued queries and authorised decisions, access follows study, role and blinding restrictions, and the review states where coverage is incomplete.
Where to start
One study-review checklist and a bounded set of records, with source links, identifiers and discrepancy handling checked before expanding. Book a demo.

Put one question to the records.

You:

What is still stopping database lock for CL-042? Prepare Friday’s review from the EDC, safety reconciliation and coding records.

Neil

There are 18 open queries, but the count alone misses the problem. Eleven are more than 14 days old, concentrated at two sites. I also found an unmatched safety record and an unfinished coding review.

Open queries by age11 of 18 over 14 days

Each dot is an open query. Red marks the study’s follow-up threshold—not clinical severity.

Start with sites 101 and 309. Closing their queries will not, by itself, complete the lock checklist.

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.

Your trial can stay in its existing systems.

Ask one question across EDC, CTMS, safety and essential documents. Neil can examine permitted records through scoped connections or supplied exports, then bring the relevant versions into a reviewable answer.

Keep the EDC as the source of case-report data and the safety system as the source of safety cases. A summary should retain study, site and record identifiers, source time and any missing coverage. Reconciliation is visible work, not a promise that connecting systems makes discrepancies disappear.

Why teams choose Seal for clinical operations.

A study review usually starts with someone exporting from the EDC, the CTMS, the safety database and the eTMF and reconciling them in a spreadsheet. Seal brings the permitted records from those systems, through scoped connections or supplied exports, into one reviewable record: the finding, its sources, the responsible role and the evidence needed to resolve it.

Neil can prepare the review across the permitted sources and say what it could not inspect; the study team decides. The review workflow is configuration, so it can be refined from one study to the next with each change reviewed and approved.

Carry the finding into the follow-up.

Configure the study-review workflow in Seal: a finding, its source records, the responsible role and the evidence needed to resolve it. A reviewer can follow the answer back to the records and forward to the outstanding work.

Use the same approach for protocol deviations, amendment rollout and inspection requests. Keep a proposed query distinct from one actually issued; a site response distinct from reviewer acceptance; and a prepared review package distinct from approval. Sponsor, CRO and site responsibilities remain explicit.

Start with one study review.

Bring the checklist and a bounded set of records. Agree the identities, source systems, access and output before connecting the wider trial.

Test a stale extract, an answered-but-open query, an unmatched identifier and a restricted source. The demonstration should show what Neil found, what it could not inspect and which statements a reviewer can reproduce from the evidence. Study teams retain control of data changes and decisions.

What the blueprint configures.

Explore the configured capabilities

Study review

Bring source-time-aligned EDC, safety and coding records into one review. Keep unresolved discrepancies and missing source coverage visible.

Electronic data capture

Configure forms, edit checks and query workflows for the study, or connect selected records from the existing EDC.

Explore this blueprint

Trial operations

Connect site plans, monitoring findings, delegated work and sponsor review to the study.

Explore this blueprint

Essential documents

Link the required document versions to study events, expected-record checks and review work.

Explore this blueprint

Protocol deviations

Retain the applicable protocol version, affected visit or site, assessment and follow-up. A possible discrepancy is not automatically a confirmed deviation.

AI review assistance

Ask Neil to draft source-backed review briefs and query proposals. Reviewers decide what to issue, accept or change.

Explore the connected records

Continue into the connected work.

AQuestions and answers

Do we have to replace our EDC?

No. Start with a scoped connection or supplied exports from your existing EDC. Agree the identifiers, fields, permissions and update frequency. Seal can provide the connected review and follow-up workflow while the EDC remains authoritative for case-report data.

What does Neil actually produce?

A review brief with source references, unresolved evidence gaps and proposed follow-up work. It can also draft queries or a configured workflow. Those proposals remain distinct from issued queries, changed study data and authorised decisions.

Can we configure data capture in Seal?

Yes. Scope the forms, edit checks, roles and review states for the intended study. Verify the configured process, integrations and required exports before operational use; do not assume that one generic form set fits every trial.

How are safety records handled?

Keep safety-case ownership and reporting responsibilities explicit. Connect the permitted records needed for reconciliation and oversight. An AI summary is not a medical assessment, a completed reconciliation or an expedited safety submission.

What about access and blinding?

Define access by study, role and permitted source scope, including any blinding restrictions. Test both allowed and denied access before use. The review should identify incomplete coverage rather than implying that unavailable records were checked.

How should we start?

Use one study-review checklist and a bounded set of records. Check the source links, identifiers, stale extracts and discrepancy handling. Agree the intended use, validation approach, training and accountable reviewers before expanding.

Bring the study that needs a clearer review.

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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Example source record

Example source record