Bioresearch Monitoring inspections focus on verifying the quality and integrity of data submitted to the FDA and confirming proper protection of human subjects. Our approach to mock BIMO inspections recreates the methodical, data-focused nature of these regulatory reviews, examining source documentation, informed consent processes, protocol adherence, and regulatory submissions. We help you identify and address compliance gaps that could impact both inspection outcomes and the credibility of your clinical data.
Our mock BIMO inspection services include, but are certainly not limited to:
Detailed review of sponsor monitoring activities and oversight responsibilities.
Comprehensive assessment of site documentation, processes, and compliance with protocol and regulations.
Evaluation of human subject protection procedures and documentation.
Detailed examination of informed consent documents and processes.
Evaluation of essential documents, including Form FDA 1572, financial disclosures, and investigator qualifications.
Assessment of electronic data capture systems and data integrity controls.
Targeted assessments of specific high-risk processes or previous inspection findings.
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.
