Function · Clinical Development

Clinical study reports from study data, protocols from one source.

SyncIQ writes the protocol and synopsis from one source, and drafts the study report from your tables, listings and figures, each number linked to its listing.

Study documents quote each other, so a changed endpoint is flagged everywhere it appears.

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The work

Clinical trial documentation, in two stages.

  • 01

    A document family that has to agree

    The protocol, synopsis, schedule of activities, SAP, investigator brochure and every site's consent form all restate the same study.

    The average protocol now carries 3.3 amendments.

  • 02

    A report that has to agree with all of it

    After database lock the clinical study report is written to ICH E3 from the tables, listings and figures.

    A late-phase clinical study report runs well over a thousand pages.

Capabilities

What SyncIQ does.

  • Protocols and synopses from one source

    SyncIQ writes the protocol, synopsis, amendments and consent forms to your template from one source.

  • Protocol amendments carried through

    Change an endpoint and every document that quoted it is flagged, with the passage to change marked.

  • Statistical analysis plans tied to the protocol

    SAPs and development plans drafted against the protocol they belong to.

  • Investigator brochures on the current safety picture

    Built from the safety record as it stands today.

  • Site and country packages, consent included

    Per-site and per-country packages assembled to each requirement, consent included.

  • Nonclinical study reports for CTD Module 4

    Drafted from the study record, to the same traceability standard as the clinical reports.

  • Clinical study reports from the tables, listings and figures

    Drafted to ICH E3 against the protocol and SAP, every number linked back to its listing.

Evidence

What a protocol amendment takes.

Each substantial amendment has to be carried through every document that quoted what changed.

76%
of protocols are amended, up from 57% in 2015Tufts CSDD, 2022 data (published 2024)
260 days
from identifying a needed amendment to its last approvalTufts CSDD, 2022 data (published 2024)

The applications

Two applications, one study record.

Both work from the same study record, so the endpoint the protocol defined is the one the report analyses.

Accountability

Every number traceable to its listing.

FDA's draft guidance on AI in regulatory decision-making asks sponsors to define the context of use and assess model risk.

SyncIQ links every figure to its listing, keeps every run auditable, and leaves interpretation with your medical writer and statistician.

Security & deployment

Coverage

What's covered, and the standards behind it.

Written against ICH E3 for the study report and ICH E6(R3) for the practice around it, with the EU Clinical Trials Regulation where trials run in Europe.

What lands on your desk

  • Clinical study reports from TLFs, protocol and SAP
  • Nonclinical study reports for CTD Module 4
  • Protocols, amendments and synopses that agree with each other
  • Investigator brochures on the current safety picture
  • Per-site and per-country packages, consent included
  • Statistical analysis plans drafted against the protocol
  • Every document quoting a changed endpoint, flagged

The protocol is becoming structured

ICH M11, the Clinical electronic Structured Harmonised Protocol, was adopted in November 2025. FDA finalized it in May 2026, and it has applied in the EU since June 2026. It assumes protocols built from structured content.

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Start where it hurts.

We'll run it live on one of your own study documents: a CSR section, a protocol or a synopsis.

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