Quality Assurance

Quality Assurance

Quality Assurance ConceptQuality Assurance in Drug, Device, and Biological Development

A simple definition of quality in clinical research is the “absence of errors that matter.” At Medpace, our collective focus on your product’s lifecycle—from bench to market—is to support operational quality control. This enables early detection of potential problems and facilitates intervention and implementation of appropriate corrective actions and when necessary, preventative action to prevent recurrence.

The time and cost of developing safe and effective medical therapies has soared in the last decade. Innovators of new medical therapies are ultimately focused on accelerating the path to market, saving lives and/or changing the quality of life of the patients. The Medpace Quality Assurance (QA) department understands the needs and concerns of our Sponsors on the path to market. QA is independent of Medpace Operations. We collaborate with Medpace Operations and our clients to ensure compliance with the protocol, SOPs, and regulatory guidelines, emphasizing subject safety and data quality/integrity.

We deliver a focused and directed risk-based approach to planning and conducting compliance assessments of regulated operations globally by applying the principles of quality risk management (QRM). We oversee the management of quality issues, fostering a culture of continuous process improvement.

Quality Assurance Core Services

  • Auditing all aspects of regulated operations with expertise in compliance assessments in GCP, GLP, GCLP and GMP
  • Inspection readiness – planning, preparation, awareness and training
  • Hosting Sponsor Audits and Regulatory Inspections
  • Administration and oversight of the Medpace Quality Management System (QMS), including but not limited to Policy and Procedure management (PPM), Learning Management and Quality Event Management (QEM)
  • Vendor Audits of service providers
  • Regulated training and education

 

Quality Assurance Services for Sponsors

Medpace can also perform Quality Assurance services for our Sponsors including:

  • Investigative Site Audits
  • Vendor Audits
  • Internal Audits
  • Regulatory Training (GLP, GMP, GCP)
  • Regulatory Inspection Preparation/Mock Regulatory Inspections