Programs built on the OIG’s seven elements and the DOJ’s three fundamental questions — designed, implemented, operated, trained, monitored, audited, and remediated across the full life-sciences life cycle.
TRESTLE's founder-led commercial compliance practice is built on the OIG's seven elements of an effective compliance program and the DOJ's three fundamental questions that federal prosecutors use to evaluate them. We design, implement, operate, train, monitor, audit, and remediate commercial compliance programs across the life sciences life cycle — from pre-clinical and pre-launch through commercial-stage and post-CIA remediation.
The Criminal Division uses three questions to evaluate every corporate compliance program. TRESTLE builds programs to answer — and evidence — each one.
Code of conduct, commercial SOPs, and role-specific policies with a documented review cycle.
Empowered CCO, board and audit-committee oversight, and cross-functional compliance committee.
New-hire, annual, and role-based training with attestation, competency checks, and remediation for gaps.
Confidential hotline, non-retaliation policy, escalation SOPs, and management-by-walking-around cadence.
Annual risk assessment, monitoring plan, sample-based audits, and evidence-preservation practices.
Consistent discipline matrix, HR-Compliance interlock, and documented enforcement rationale.
Investigation SOPs, root-cause analysis, remediation tracking, and reportable-events workflow.
Right-sized code of conduct, conflict-of-interest and grants policies, HCP-engagement guardrails, and IP/privacy hygiene — sized to a small team without over-building.
Commercial SOPs, sales & medical-affairs training, promotional review, speaker programs, advisory boards, FMV, PDMA, sunshine reporting, and monitoring plan — live before first patient.
Steady-state monitoring, annual auditing, board reporting, investigations, discipline, and continuous improvement — with objective evidence for every DOJ question.
CIA compliance, IRO coordination, reportable-events workflow, and buyer-side or seller-side diligence packages that hold up under scrutiny.
Bring the launch, monitoring, diligence, or program question in front of you. We’ll help define a practical and defensible path forward.