In addition to our extensive audit, SOP, and training services, QC2 provides the following consulting services, which are customized for your specific project and budget needs:

Audit Plan Development

Assistance with review of current audit plans and/or development of new audit plans, including selection of sites and vendors for audit and timing of audits, to ensure thorough compliance assessments for your development program.  Guidance with respect to for-cause audits of suspected non-compliant or fraudulent activities.

Audit Follow-Up and Review of Corrective Actions

Submission of audit observations to auditees, tracking and review of responses and corrective actions, and closure of audits.  Assessment of adequacy of the CAPA process and confirmation of timely and effective resolution.

Preparation for FDA Inspections and Mock FDA Inspections

Mock FDA audits at investigator sites, sponsors, CROs, and vendors to assess preparedness for an FDA inspection.

Clinical Outcomes Assessment (COA) Consulting

Clinical Outcomes Assessment (COA) consulting, including Patient Reported Outcomes (PRO), Clinician Reported Outcomes (ClinRO), and Observer Reported Outcomes (ObsRO).  Consulting services include issues related to questionnaire/instrument administration (e.g., providing guidance on administration plans/process) and questionnaire/instrument content (e.g., item review and revision, item development, identifying potential impact of items on outcomes, providing recommendations for COA reporting/write-up).

Click here for more information on COA consulting services.