Site establishment and readiness
Operational assessments, site workflows, research team roles and protocol-specific readiness planning.
Integrated solutions for sustainable growth
Consulting across GxP quality and compliance, management advisory, and the entire site development lifecycle from investment and business strategy to operational readiness and reliable clinical data generation.
Quality and compliance
An audit against ICH E6(R3) that reports what an inspector would find, before one does. Gap analysis across essential documents, the informed consent process, source data, drug accountability, and delegation and training records. The output is a findings report with severity ranking and a remediation plan.
Writing the SOP framework from scratch, or rebuilding one that was inherited and never followed. Mapped to ICH E6(R3), version-controlled, and written so staff use them rather than sign them once a year.
A mock inspection run the way a regulator or a sponsor auditor would run it, staff interview preparation, essential document review, and CAPA support on what it turns up.
Preparing for a sponsor qualification visit or a CRO audit, and responding to the findings afterward.
Management consulting
Whether an organization should enter clinical research at all, and for one already running studies, whether to expand, restructure, or stop. Patient volume by indication, the competitive site landscape, the regulatory timeline, and realistic study flow, ending in a defensible answer — including “not yet”.
Per-study economics, staffing and capital build, break-even timing, and scenario ranges. The organization keeps the model, not only the conclusion.
What the site or SMO needs in order to run: staffing plan, space and equipment requirements, and the sequence from decision to first patient in — or the redesign of an operation that is already running.
Decks and supporting analysis for internal approval or for outside capital.
Clinical research site development
Building sustainable, research-ready site operations
Supporting the establishment, development, and growth of clinical research sites through operational planning, quality systems, digital documentation solutions, and financial advisory services. Our approach focuses on building sustainable, inspection-ready research operations aligned with regulatory requirements and industry best practices.
ISF and eISF support
Investigator Site File organization, essential-document controls, electronic workflow selection and implementation support.
Research operations and growth
Site development planning, study coordination processes, team training and sustainable operating models.
Inspection coming, or a decision to make?
Tell us about your quality, operational, financial or site-development challenge. We will discuss an appropriate scope of work.