The Three-System Problem

Every clinical trial runs on three systems that don't talk to each other.

EDC captures the patient data. CTMS manages the sites, monitors, and payments. eTMF holds the regulatory documents. Three vendors. Three logins. Three data models. Three support contracts. And one operations team trying to keep them synchronized through spreadsheets, manual exports, and weekly reconciliation meetings.

The consequences compound. When a site coordinator enters a patient visit in EDC, the CTMS has no idea it happened. Someone has to manually update the tracker to trigger the site payment. When that update is late—and it's always late—sites get frustrated. Frustrated sites enroll slower. Enrollment timelines slip.

When a monitor identifies a protocol deviation during a site visit, they log it in their trip report in CTMS. But understanding the impact on data analysis requires checking EDC. The deviation exists in two places, described differently, with no guaranteed link between them. When the FDA asks for a complete deviation history, someone spends days reconciling reports.

The Trial Master File is supposed to be the regulatory record of the trial. In practice, it's an archive where documents go to die. Site essential documents generated in CTMS get manually uploaded to eTMF weeks later. Patient safety reports captured in EDC exist separately from the safety documentation in the TMF. The file is always incomplete, always catching up, always a liability.

This isn't a technology problem. It's an architecture problem. These systems were built by different companies for different purposes. Integration is always an afterthought—API connections that break, file exports that lag, mappings that drift. The fundamental assumption is that these domains are separate. They're not.

One Platform

Seal Clinical is one platform where EDC, CTMS, and eTMF share a single data model.

A patient visit isn't entered in EDC and then synced to CTMS. The visit is one object, visible in both contexts. When the coordinator marks the visit complete, the payment trigger fires automatically. When the monitor reviews the visit during their trip, they see the same data the data manager sees. When someone needs to understand what happened, they don't reconcile—they look.

A protocol deviation isn't a note in a trip report that someone later copies into a tracking spreadsheet. The deviation is a first-class entity linked to the visit, the subject, the site, and the protocol version. When you query for deviations, you get all of them—regardless of which workflow created them.

The TMF isn't an archive. It's a living reflection of trial operations. When a site is activated in CTMS, the essential documents file automatically. When a serious adverse event is reported in EDC, the safety narrative links directly. TMF completeness isn't a metric you chase at inspection time—it's a byproduct of doing the work.

Electronic Data Capture

Seal EDC is built for the modern trial. Sites don't want clunky forms that feel like they were designed in 2005. They want something that works like the software they use everywhere else—fast, intuitive, mobile-friendly.

Forms are designed visually. Drag fields, set edit checks, define skip logic. No programming required for standard forms. When you need complex derivations or cross-form validations, the expression language handles it. Preview your forms exactly as sites will see them before you go live.

Edit checks fire in real-time as data is entered. Sites see validation errors immediately, not days later in a query. The goal is clean data at the point of capture, not data cleaning campaigns after the fact. When an edit check does generate a query, sites respond in context—they see the question next to the data, not in a separate query management module.

Randomization and drug supply integrate directly. When a subject is randomized, the treatment assignment flows through to the dispensing log. No manual transcription. No mismatches between what EDC says and what the site dispensed.

Medical coding happens continuously. As adverse events and medications are entered, coding suggestions appear. Coders review in batches rather than facing a mountain at database lock. The MedDRA and WHO Drug dictionaries update automatically.

Clinical Trial Management

CTMS in Seal isn't a separate module bolted onto EDC. It's a different view of the same trial.

Site management starts with feasibility. Track potential sites through qualification, selection, and activation. Document the regulatory submissions—IRB approvals, contracts, budgets. When a site activates, their essential documents flow to eTMF automatically.

Monitoring happens in context. Monitors see their assigned sites with current enrollment, open queries, and pending issues. Trip reports capture findings linked directly to the subjects and visits reviewed. When a monitor identifies a protocol deviation, it creates the same deviation record the data manager will see. No translation layer. No reconciliation.

Site payments trigger from milestones. When a subject completes a visit, the payment accrues. When enrollment hits a threshold, the bonus triggers. Finance sees accrued versus paid across all sites. Sites see their own payment history. No more "where's my check?" emails.

Study metrics are real-time because they derive from actual operations. Enrollment curves, screen failure rates, query cycle times—all calculated from the data as it exists right now. No ETL jobs. No dashboard refresh schedules. The number you see is the number that's true.

Trial Master File

The eTMF in Seal follows the TMF Reference Model structure. Zone, Section, Artifact. The taxonomy is there because inspectors expect it. But the filing isn't manual.

When a document is created in operations, it knows where it belongs. Site regulatory submissions file to the site section. Protocol amendments file to the trial section. Monitoring visit reports file with the date and site. You don't organize documents—you generate them in context and they organize themselves.

Completeness tracking is automatic. The system knows which artifacts are expected based on the trial phase, the active sites, and the visits conducted. Missing documents surface immediately. When an inspection is scheduled, the completeness report shows exactly what needs attention.

Document QC happens before filing. Metadata validation, naming convention checks, placeholder detection. Reviewers approve documents through a workflow, and the audit trail captures every version. When the inspector wants to see the approval history of a protocol amendment, you show them—without digging through email archives.

Safety Integration

Adverse events captured in EDC flow directly to safety workflows. When a serious adverse event meets reporting criteria, the system initiates the appropriate pathway. Expedited reports to regulators. Notifications to investigators. Updates to the Investigator's Brochure.

The safety database isn't a separate system. The same adverse event record that the site entered appears in aggregate safety analyses. When you need to understand a signal, you drill from the aggregate directly to the source. No case matching. No reconciliation against the clinical database.

Pharmacovigilance requirements extend beyond the trial. Post-marketing safety reports follow the same structure. The transition from clinical to post-market isn't a data migration—it's a configuration change.

The Inspection

When the FDA arrives, they're not auditing your systems. They're auditing your trial. They want to understand what happened, why it happened, and whether you maintained control.

In a fragmented world, answering their questions requires pulling data from three systems, reconciling discrepancies, and hoping nothing falls through the cracks. In Seal, the answer to "show me all deviations for this site" is one query. The answer to "show me the training records for everyone who touched this subject's data" is a click.

The TMF is always ready because it was built through operations. The edit check history exists because it was captured at the time. The audit trail is complete because every action was logged in one system.

You don't prepare for inspections. You run your trial well, and inspection readiness is the result.

For the Biotech Running Phase 1

You don't need the full enterprise clinical suite. You need something that works for a single trial with ten sites and fifty subjects. But you also need something that scales when Phase 2 is multi-regional and Phase 3 has two hundred sites.

Seal Clinical scales down and up. Start with basic EDC and CTMS. Add eTMF when you need regulatory rigor. Add safety database integration when your aggregate reporting requirements mature. The data model supports the expansion because it was designed for the full lifecycle from the start.

You're not buying a startup tool that you'll rip out later. You're buying a platform that grows with your pipeline.