In addition to our extensive audit, SOP, and training services, QC2 provides the following consulting services:
Audit Plan Development
QC2 offers assistance with reviewing current audit plans and developing new ones. This includes selecting sites and vendors for audit, determining the timing of audits, and ensuring thorough compliance assessments for your development program. We also provide guidance on conducting for-cause audits in cases of suspected non-compliance or fraudulent activities.
Audit Follow-Up and Review of Corrective Actions
QC2 can submit audit observations to auditees and then track, review, and evaluate the audit responses and corrective actions. Additionally, we can assess adequacy of the CAPA process and confirma timely and effective resolution.
Preparation for FDA Inspections and Mock FDA Inspections
QC2 conducts mock FDA audits at investigator sites, sponsors, CROs, and vendors to assess preparedness for an FDA inspection.
Clinical Outcomes Assessment (COA) Consulting
QC2 provides 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.
