Clinical development and regulatory affairs, converged
MedicOrbis runs your trials, safety, quality and global submissions on one data model, one audit trail and one regulatory engine. A fact entered once reaches every document and every agency that needs it.
Start with one process on one trial, from $24,00011. Prove it against success criteria you write, then decide.
Every figure here comes from a peer-reviewed study or a regulator's own record.
1 Published external source9 MedicOrbis internal figureHow we cite
An industry running on point solutions that were never designed to meet.
More than fifteen on complex trials: one for data capture, another for the trial master file, another for safety, another for submissions. None of them share a data model12.
The same fact is re-keyed into system after system, and each hop is a chance to introduce an error nobody will find until an audit.
When an inspector asks how a decision was reached, the answer has to be reconstructed from documents and inboxes.
A cross-programme view means an extract, a spreadsheet and a fortnight, by which time the position has changed.
Another team, another document set, and an assessed six to twelve months of additional elapsed time10.
Choose the route that matches your organisation. Each one leads to the processes that cost you most today.
For regulatory, quality and clinical teams carrying MDR, IVDR and FDA device obligations.
For teams taking a molecule from protocol to marketing application, often with a lean regulatory function.
For CROs running many sponsors, who need separation, speed and something to resell.
A configured operating platform, not a reference architecture. These counts are read from the live configuration.
MedicOrbis internal figures, read from the live platform configuration and the process analysis, August 2026.
Sixty processes were assessed for manual effort, the share automation can remove, and impact10. These seven rank highest among processes already configured end to end9.
| Use case | Manual effort today 10 | Reduction 10 | Configured stages 9 |
|---|---|---|---|
| Marketing application compilation and submission | 2,000-5,000 hours per submission | 40-50% | 524 |
| Post-market pharmacovigilance | 500-2,000 hours per product per year | 55-65% | 481 |
| Multi-jurisdictional regulatory intelligence | 500-1,000 hours per year | 70-80% | 317 |
| Clinical evaluation for European device regulation | 500-1,500 hours per device | 45-55% | 398 |
| Technical documentation and requirements compliance | 400-1,200 hours per device | 40-50% | 193 |
| Statistical analysis and submission datasets | 400-800 hours per trial | 50-60% | 459 |
| Device vigilance and field safety action | 200-800 hours per device per year | 60-70% | 371 |
| Total configured depth behind the seven | 2,743 |
The comparison that matters is not feature against feature. It is whether the joins exist at all.
| Point solutions stitched together | MedicOrbis | |
|---|---|---|
| Data | A separate model per system, reconciled by hand | One model, entered once, used everywhere |
| Audit trail | Fragmented across systems, reconstructed on demand | One immutable trail across every action |
| Multi-market filing | Separate teams and document sets per market, six to twelve months added10 | One dataset, packaged per market |
| A protocol change | Manual propagation to every downstream document | Propagates automatically, with impact assessed |
| Inspection readiness | A project run before each inspection | A property of the system, continuously |
| Cross-programme view | An extract, a spreadsheet and a fortnight | A live query against one model |
| Cost of integration | Paid once per system pair, then again at every upgrade | Not incurred |
Regulated software is bought by five people at once. Here is what each of them needs to hear.
Will it survive an inspection? Every record and every process action carries who, what, when, the previous value and the new one. Nothing of consequence happens outside a recorded process. How the audit trail works
Will sites carry more burden? One identity for every subject, site and document means a protocol change propagates to the consent form, the case report form and the budget without re-keying. Trial conduct processes
Can we validate it? The platform is designed to the electronic records and signatures expectations that regulated clinical and device operations are held to, including 21 CFR Part 11 and EU Annex 11. Validation and data integrity
Will it trap our data? The data foundation is CDISC-native and exchanges through HL7 FHIR and open APIs, and the tenant can be hosted in the region your policy requires. Standards and integration
We would rather you saw the platform run one of your own processes than take a website at face value.
Ninety minutes on the live platform, against whichever two of the seven use cases matter most to you.
We size the effort and the reduction against your own baseline rather than our assessed ranges.
One process, configured end to end with your data, with success criteria you write.
Expand process by process, in whatever order your risk and your calendar dictate.