Clinical operations
Cross-system reconciliation across CTMS, eTMF, EDC and sponsor portals with HITL at the decision points.
Industry
Pharmaceuticals
Clinical workflows, regulatory submissions, pharmacovigilance with audit.
The sector reality
How the sector operates today.
Pharmaceutical operations live under the highest documentation standard in the economy. Every action — from a lab notebook entry to a patient adverse event — has to be captured, signed, version-controlled and available for inspection on demand.
Regulatory submissions consume quarters. Compiling, formatting, cross-referencing and submitting to agencies in multiple jurisdictions is a parallel operation that mirrors the actual scientific work.
Pharmacovigilance has zero tolerance for slippage. Adverse event reports have legally binding timelines; a missed deadline is not an inconvenience, it is a finding.
Clinical operations cross many systems and many sites. CTMS, eTMF, EDC, lab systems, sponsor portals — each with its own format, and reconciliation is rarely anyone's favorite job.
Where Sommatic fits
A cognitive layer that shapes itself to your operation.
Sommatic operates as a governed layer over clinical and regulatory workflows. Every action carries actor identity, role, signature and the policy applied — the evidence inspectors expect is captured as the work happens.
Pharmacovigilance intake gets compressed to the speed timelines demand. Cases get classified, enriched and routed under SOP with the regulator-bound deadline as a structural constraint, not a reminder.
Regulatory submissions assemble from the work, not from a separate scramble. Cross-references, formatting and per-agency adjustments run under explicit rules. The submission becomes a query against the work, not a quarter of compilation.
Clinical operations stop losing context between systems. CTMS, eTMF, EDC and sponsor portals share one cognitive layer that reconciles, flags and routes — leaving the scientific judgment where it belongs.
Common workflows
The first things the cognitive layer starts operating.
Pharmacovigilance intake
Adverse event cases classified, enriched and routed under SOP with the regulator-bound deadline enforced structurally.
Regulatory submissions
Submission packages assembled from operational evidence, formatted per agency, cross-referenced under explicit rules.
Quality & deviation management
Deviations, CAPAs and quality events tracked end-to-end with evidence each inspector would expect already attached.
GxP audit & inspection evidence
Signed, version-controlled decision chains exported on demand for inspectors, auditors and partners.
What you will see change
Three things your team will notice first.
Pharmacovigilance deadlines stop slipping
Adverse event timelines become a structural constraint of the workflow, not a deadline someone has to remember.
Submissions assemble from the work
Regulatory packages become queries against operational evidence — quarters of compilation collapse to weeks.
Inspections become routine, not crisis
GxP evidence is captured as the work runs. Inspectors receive signed chains, not reconstruction projects.
Where you start
Your recommended entry point.
Start with one clinical or pharmacovigilance workflow under audit. Expand to regulatory submissions once the trace shape is approved.