Plan, coordinate, submit, track: at every step your experts copy-paste between documents, trackers and portals. SYNCRA does that part, so they can spend their time on the decisions only they can make.
Regulatory work runs on email, spreadsheets, folders and people holding the context together. SYNCRA gives it one place for the life of the trial, for in-house teams and their outsourcing partners.
Documents, requirements, decisions and deadlines, linked to the study and submission. Your files stay where they are.
AI agents organise incoming information, surface context, trace what a change affects, prepare next steps and flag gaps.
Experts review proposed actions, decide, and oversee progress and deliverables across teams, CROs and sites.
Checks a submission against the rules in force on the submission date. Each finding cites the article and document, and proposes the next step.
54.7% of Swiss human-research submissions come back with conditions at first decision. BASEC 2024
For a protocol amendment: affected documents, whether it is substantial, who owns each update, what goes to the ethics committee.
190 days median from internal approval of an amendment to the last ethics approval; 76% of industry protocols have at least one. GETZ 2024
A versioned knowledge graph of Swiss and EU clinical-trial regulation from Fedlex and EUR-Lex, so a check can cite the rule in force on a given date.
Built for the Swiss and EU submission routes (BASEC, Swissmedic, CTIS) and the standards reshaping them, from ICH E6(R3) to the machine-readable protocol standard ICH M11.
Every action and decision is recorded: who proposed it, who approved it, when.
Files stay in SharePoint or your CRO's system. SYNCRA links to them; nothing is migrated.
Each check cites the Swiss or EU rule and guidance version in force on the submission date.
Patient-identifying text can be filtered in the browser before processing.
Swiss-hosted or on your own infrastructure. Your content never trains AI models.
The system prepares; your regulatory lead reviews, decides and stays accountable.
Pick a time and we'll walk you through it.
Open the booking page in a new tab or write to hello@syncra.ch.
Based in Zürich, starting with Swiss requirements and expanding across the EU. Write to us and we'll show what SYNCRA can take off your plate.
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