Libertas Software Research Partners with 360 Clinical Research Consultancy to Deliver Highly Auditable Incident Response Through ORDU Studio

Portadown, Northern Ireland — Libertas Software Research Ltd (LSR) is pleased to announce a formal partnership with 360 Clinical Research Consultancy (360 CRC), a specialist compliance and auditing consultancy serving clinical research, pharmacovigilance, and regulated AI environments.

The partnership's primary focus is ORDU Studio, LSR's modular multi-agency incident management platform: bringing 360 CRC's audit expertise directly into how ORDU Studio is designed, evidenced, and operated, so that incident response delivered through the platform stands up to independent scrutiny, not just internal review. As part of the arrangement, Shane Comiskey, Managing Director of 360 CRC, will be available as a Subject Matter Expert (SME), brought into ORDU Studio development, and into wider LSR client engagements, as and when compliance and audit expertise is required.

Why This Partnership Matters

Incident response sits at the intersection of operational pressure and regulatory obligation. When a multi-agency response is under way, the priority is coordinating action, but every decision, escalation, and resource allocation made in that moment may later need to be reconstructed, justified, and defended to a regulator, an inspection body, or a public inquiry. A system that helps agencies respond well but can't produce a defensible record of how they responded is only doing half the job.

ORDU Studio was built to close that gap: a modular incident management platform designed so that the record it produces during a live response is inherently auditable, not something assembled after the fact from disparate logs and recollections. This partnership strengthens that design principle by bringing in an independent auditing specialist to test it.

360 CRC brings deep experience across clinical trial compliance, pharmacovigilance audits, investigator site audits, data integrity assessments, computer system validation, and independent AI audit and validation, increasingly relevant as AI becomes embedded in regulated systems. For C-suite stakeholders, this means ORDU Studio's evidence trails, reporting structures, and system controls are being shaped and tested against the kind of external, evidence-based scrutiny that regulators, boards, and inspection bodies expect to see, not just software best practice.

What This Means in Practice

For organisations adopting ORDU Studio, this partnership means:

• Independent audit input on how ORDU Studio captures, structures, and preserves the record of an incident response, from initial escalation through to stand-down and after-action review.
• Inspection readiness by design, so that when a regulator, oversight body, or public inquiry asks "how was this decision made and when," the answer already exists in the system record rather than needing to be reconstructed.
• A dedicated SME resource on call — Shane Comiskey — who can be brought into ORDU Studio's development, or into a specific client engagement, at the point compliance or audit expertise is needed, understanding both the regulatory landscape and the platform's architecture rather than a generalist auditor learning it from scratch.
• Shared accountability between software delivery and audit assurance, reducing the risk of blind spots that can emerge when the same team builds and reviews its own work.

This is particularly relevant for organisations with statutory reporting obligations, multi-agency coordination requirements, or exposure under frameworks such as Martyn's Law, where the record of a response can carry as much weight as the response itself.

Shane Comiskey's Role as SME for ORDU Studio

As MD of 360 CRC, Shane brings hands-on regulatory and audit leadership to this SME role. His focus is testing ORDU Studio against the standard an external inspector or inquiry would apply: not "does the system log activity," but "does the resulting record hold up when someone outside the organisation examines it critically."

ORDU Studio supports organisations navigating complex regulatory and operational obligations, including those introduced under the Terrorism (Protection of Premises) Act 2025 (Martyn's Law). Having audit expertise available on this basis, brought in at the right points in development rather than as a one-off pre-launch check, means the platform's approach to evidence and reporting is shaped by someone whose day-to-day work is defending compliance positions under real regulatory pressure.

About Shane Comiskey

Shane Comiskey brings over two decades of GxP quality assurance and audit leadership to this role. Before founding 360 CRC, he held senior QA auditing positions at Chiltern (Senior Director, Clinical Quality Assurance), ICON plc (Principal QA Auditor), PharmaNet/i3, and MDS Pharma Services, where his responsibilities included managing global teams of clinical QA auditors, directing global audit plans, and leading inspection readiness programmes across GCP, GCLP, GVP, GMP, and computer system validation (CSV/21 CFR Part 11).

Over the course of his career, Shane has hosted and prepared organisations for regulatory inspections by the FDA, MHRA, BfArM, and CFDA, and has advised on inspection readiness for BLA, MAA, and MAH approval programmes, including biologics and advanced therapy medicinal products. Since 2018, he has operated as an independent clinical research compliance consultant through 360 CRC, providing GxP consultancy, audit services, quality management system setup, risk management, and, more recently, AI governance and AI system auditing to organisations across the pharmaceutical and life sciences sector.

That track record, built on defending compliance positions in front of some of the most rigorous regulatory bodies in the world, is precisely the lens ORDU Studio needs applied to it. Shane holds an MSc in Biotechnology (1999–2000) and an MSc in Computer Science (2001–2002), both from Ulster University, a combination that reflects the dual grounding in life sciences and technology that his audit work draws on.

Looking Ahead

This partnership reflects a broader principle behind how LSR builds ORDU Studio: good incident management software is necessary but not sufficient in regulated, high-consequence environments. Real assurance comes from combining strong engineering with independent, expert scrutiny of the record that software leaves behind, and building that scrutiny in as a standing capability, not a one-off exercise before an audit.

We're looking forward to what this partnership makes possible for ORDU Studio, and for the organisations that rely on it to deliver incident response that's not just effective, but demonstrably auditable.

To learn more about 360 Clinical Research Consultancy, visit 360clinicalresearch.com. To discuss how this partnership could support your organisation's compliance programme, get in touch with the Libertas Software Research team.