Clinical trial data integrity and subject protection are foundational to successful product development and regulatory approval. Our approach focuses on conducting detailed, systematic evaluations that examine all aspects of clinical trial conduct against regulatory requirements and protocol specifications. We help you identify and address potential compliance issues that could impact data acceptability or subject safety before they become regulatory concerns.
Our clinical site audit services include, but are certainly not limited to:
Assessment of site capabilities and compliance infrastructure before study initiation.
Targeted evaluations triggered by specific concerns or issues at a clinical site.
Independent verification of site compliance and monitoring effectiveness.
Comprehensive review of site documentation and data at study completion.
Mock regulatory inspections to prepare sites for agency oversight.
Focused reviews of informed consent processes and IRB/IEC oversight.
Evaluation of CRO performance and compliance with delegated responsibilities.
Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.
Get contracted full-time consultant/contractor (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.
We rapidly identify and place direct hire candidates in a variety of positions and job functions. Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates, especially in specialized, competitive areas.
