Quality Assurance in Drug, Device, and Biologic 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 have 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
The Medpace QA team has a broad range of experience and expertise in the drug/device development process, supporting Medpace partners throughout the project lifecycle. By extending and maximizing our collective experience, we provide streamlined and effective independent oversight of clinical trials. Core quality assurance services include:
- Investigator site audits
- Quality event management/CAPA
- Vendor audits
- System and process audits
- GLP audits
- Regulatory inspection preparation support and management
- Regulatory GxP training
- Oversight and management of document control
Quality Assurance Services for Sponsors
Medpace can also perform Quality Assurance services for Sponsors including:
- Investigative Site Audits
- Vendor Audits
- Internal Audits
- Regulatory Training (GLP, GMP, GCP)
- Regulatory Inspection Preparation/Mock Regulatory Inspections