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Syncop Platform · Clinical trial operations

From protocol to patient, on the record.

Three services that share one identity, one protocol and one audit ledger. StudyForge holds the protocol, LeanDelegate decides who may do what, and CohortGrid allocates subjects to cohorts.

Three services, one platform

Each service does one job well and can be adopted on its own. Together they carry a trial from its protocol to the subjects enrolled in it, without a spreadsheet in between.

Delegation & training

LeanDelegate

The Delegation of Authority log and staff training, held in lockstep.

If Training ≠ Valid, then Delegation = False.

  • Delegations signed by grantee and PI with Part 11 e-signatures
  • Training certificates read by OCR and confirmed by a person
  • Site compliance across a study, and PI transfers handled
  • DoA log and audit trail exported as PDF and CSV
Open LeanDelegate

Protocol repository

StudyForge

Every protocol as a CDISC USDM 4.0 study definition, versioned and checked.

  • Conformance checked on every write, with an immutable version history
  • Import from ClinicalTrials.gov, or extract a protocol PDF with a reviewer's approval
  • Schedule of Activities, version comparison and a browsable study tree
  • Hands a study to LeanDelegate as its task catalog
Open StudyForge

Cohort allocation In development

CohortGrid

Capped cohorts for dose-escalation and early-phase trials, without slot races.

  • Reservations that never over-enrol a cohort, however many sites screen at once, and lapse on their own
  • Allocation confirmed with a Part 11 signature, only by an investigator delegated to enrol
  • A safety gate between subjects, and every subject's DLT window tracked
  • 3+3, BOIN and mTPI recommendations; the next dose opens on the SRC chair's signature
  • An inspection-ready allocation and safety ledger, in PDF/A and CSV
Open CohortGrid

How they work together

  1. StudyForge records the protocol and every amendment, and gives LeanDelegate the study's activities as delegable tasks.
  2. LeanDelegate delegates those tasks only to staff whose training is valid, and keeps the signed log.
  3. CohortGrid allocates subjects to cohorts, and confirms an allocation only for an investigator LeanDelegate shows as delegated to enrol.

All three write to one hash-chained audit ledger, so an inspector follows a subject's allocation, the delegation behind it and the protocol version it rests on in one place. Agents reach the platform through its REST APIs and a Model Context Protocol server.