Clinical Operations (EDC, CTMS, eTMF)

Seal Clinical Operations is a unified platform that combines Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), and Electronic Trial Master File (eTMF) within a single shared data model. It is designed for clinical operations teams running pharmaceutical and biotech trials who are managing the coordination burden that arises when these three functions operate as separate systems from different vendors. Rather than synchronising data across disconnected tools, Seal treats patient visits, protocol deviations, site documents, and safety events as single objects visible across all operational contexts.

The platform addresses what it describes as an architecture problem: EDC, CTMS, and eTMF have historically been built by different companies for different purposes, with integration treated as an afterthought. Seal's approach is to replace that fragmented architecture with one data model, so that a site coordinator entering a patient visit, a monitor reviewing site performance, and a data manager resolving queries are all looking at the same underlying record — without manual exports, reconciliation meetings, or duplicate entry.

Core Architecture

• EDC, CTMS, and eTMF share a single data model; data entered in one context is immediately visible in all others without synchronisation jobs or API mappings.
• A patient visit is one object, not a record in EDC that must be manually reflected in CTMS enrollment trackers.
• A protocol deviation is a first-class entity linked to the subject, visit, site, and protocol version — not a note in a trip report that must later be copied into a tracking spreadsheet.
• The TMF is a live reflection of trial operations rather than a retrospective archive; documents file automatically as operational events occur.
• Study metrics are calculated in real time from operational data, with no ETL jobs or dashboard refresh schedules.

Electronic Data Capture

• Forms are designed visually using drag-and-drop field placement, edit check configuration, and skip logic definition; no programming is required for standard forms.
• Complex derivations and cross-form validations are supported through an expression language.
• Edit checks fire in real time at the point of entry; sites see validation errors immediately rather than receiving queries days later.
• When an edit check does generate a query, sites respond in context — the question appears next to the relevant data, not in a separate query management module.
• Randomisation and drug supply are integrated directly; treatment assignment flows through to the dispensing log without manual transcription.
• Medical coding runs continuously as adverse events and medications are entered; MedDRA and WHO Drug dictionary suggestions appear at entry, and dictionaries update automatically.
• The platform targets approximately 90% of errors corrected at entry before they become formal queries.

Clinical Trial Management

• Site management covers the full lifecycle from feasibility through qualification, selection, activation, and close-out.
• Regulatory submissions, IRB approvals, contracts, and budgets are tracked within the same system; when a site activates, essential documents flow to eTMF automatically.
• Monitors access their assigned sites with current enrollment figures, open queries, and pending issues in a single view.
• Trip reports capture findings linked directly to the subjects and visits reviewed; protocol deviations identified during monitoring create the same deviation record visible to data managers.
• Enrollment curves, screen failure rates, and query cycle times are calculated from live operational data.
• Risk-based monitoring is supported through site performance dashboards that identify which sites require attention.

Electronic Trial Master File

• The eTMF follows the TMF Reference Model structure across three zones: Zone 1 for central trial documents (protocol, Investigator's Brochure, regulatory submissions, safety reports), Zone 2 for global oversight documents (DMC charters, SAE reconciliation, coding dictionaries, lab certifications), and Zone 3 for site-level documents (informed consents, delegation logs, monitoring reports, IP accountability).
• Documents generated in operations file automatically to the correct zone, section, and artifact location based on context; site regulatory submissions file to the site section, protocol amendments to the trial section, and monitoring visit reports with the relevant date and site.
• Completeness tracking is automatic; the system calculates expected artifacts based on trial phase, active sites, and visits conducted, and surfaces missing documents immediately.
• Document QC occurs before filing and includes metadata validation, naming convention checks, and placeholder detection.
• Reviewers approve documents through a workflow with a full audit trail capturing every version; approval history is available on demand without searching 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 expedited regulatory reports, investigator notifications, and Investigator's Brochure updates.
• The adverse event record entered by the site is the same record used in aggregate safety analyses; there is no separate safety database requiring case matching or reconciliation against the clinical database.
• Post-marketing safety reports follow the same structure as clinical safety reporting; the transition from clinical to post-market is described as a configuration change rather than a data migration.

Protocol Deviation Tracking

• Deviations are captured in context and linked to the subject, visit, site, and protocol version.
• A single deviation record is visible to both monitors and data managers, regardless of which workflow created it.
• Querying for all deviations at a site or across the trial returns a complete set without requiring reconciliation between systems.

CDISC Compliance

• Forms are built with CDASH-compliant fields.
• SDTM-ready exports are available, allowing regulatory submissions to be built from operational data without separate transformation projects.

AI Capabilities — Neil

• Neil is Seal's AI assistant, which generates study structure from a plain-language protocol description, including visit schedules, CRF templates with CDASH-compliant fields, standard edit checks, and TMF artifact expectations.
• For protocol amendments, Neil updates the visit schedule, adds or modifies CRFs and edit checks, and flags sites requiring re-consent based on a description of what changed.
• Neil suggests MedDRA and WHO Drug codes continuously as adverse events and medications are entered.
• Neil identifies data inconsistencies and drafts query text for data manager review.
• Neil monitors TMF completeness against expected artifacts and surfaces gaps, such as essential documents not filed for a recently activated site.

Inspection Readiness

• Because all data and documents are captured in one system, regulatory inspection queries — such as all deviations for a site or training records for everyone who accessed a subject's data — are answered through a single query or a single click.
• The TMF completeness report shows exactly which artifacts are missing when an inspection is scheduled.
• Edit check history, audit trails, and deviation records are complete by virtue of being captured at the time of the operational event, not assembled retrospectively.

Implementation and Scalability

• A simple Phase 1 trial with ten sites and fifty subjects can be live in weeks; complex registrational trials are estimated at two to three months, compared to six to twelve months typical of enterprise EDC implementations.
• AI generates the study structure from the protocol; the clinical team reviews and adjusts rather than building from a blank database.
• Validation runs against pre-validated platform components; sites access through a web browser with no installation required.
• Mid-study transitions from legacy systems are supported, with data migrated with audit trails preserved.
• The platform supports trials from Phase 1 through Phase IV and post-approval safety studies; EDC, eTMF, and safety database integration can be added incrementally as trial complexity grows.

Seal Clinical Operations is accessed through a web browser and supports multinational trials including sites requiring translated forms. The platform's data model is designed to support the full clinical trial lifecycle from protocol design through