Controlled definitions
Each term carries an owner, an approved version and a lifecycle, with every change recorded.
Life sciences
Every definition in the submission, approved and traceable
Endpoints, populations and safety terms are defined in protocols, implemented in analysis and reported to regulators. SynkBase tracks each definition across all three.
From protocol amendment to submission
- Step 1Protocol amendmentAn endpoint or event definition changes.
- Step 2Impact tracedAnalysis programmes, documents and open tasks are listed.
- Step 3Change approvedReviewed and signed off, with the reason recorded.
- Step 4History keptThe full trail is ready for inspection.
Where it goes wrong
A protocol amendment changes how an event is classified. The analysis programmes and the trial systems need to follow, and the change history has to stand up to inspection.
When the history lives in documents and ticket comments, assembling it for an inspection is slow and incomplete.
What SynkBase does for life sciences teams
Amendment impact traced
When a definition changes, see every analysis, document and open work item that depends on it.
Inspection-ready history
Approvals, rejections and overrides are recorded in an append-only trail you can export.
Consistency across partners
Where work is split with contract research partners, both sides check against the same approved definitions.
Where the compliance hook sits
- Audit trails for electronic records (21 CFR Part 11 and EU Annex 11)
- Consistency between protocol, analysis plan and submission
- Sponsor and CRO oversight of shared definitions