Quality Management & Quality Assurance

Uncompromising quality demands an experienced quality management team and sophisticated technology. We’ve got both.

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A full range of auditing tools

Services that ensure the integrity of your studies

The growing level of regulatory stringency in drug development demands quality assurance at the highest level – no shortcuts, no compromises.

Our global Quality Management Systems and Quality Assurance group recognizes this need and provides a full range of services to ensure the integrity of your studies. We offer:

  • Investigative site audits
  • Trial master file audits
  • Database audits
  • Clinical study report audits
  • Statistical report audits
  • Vendor audits

In addition to providing study-specific auditing services to sponsors, our quality management team follows a thorough internal audit schedule.

WHITE PAPER

Implementing quality

Biotech companies with resource constraints may be hampered in efforts to design and develop the required risk-based clinical quality management system.

WHITE PAPER

Planning for quality

Risk-based monitoring is a comprehensive approach to clinical trial monitoring that focuses on proactively identifying and addressing risks to patient safety and data quality. Effectively navigating the shift from traditional to risk-based monitoring requires collaboration and careful planning.

Related Services

Quality management is part of a wide range of service offerings that include medical and regulatory affairs, project management, and global compliance. Follow the links below to learn more about how clients gain from our specialized expertise.

Medical and Regulatory Affairs

Project Management

Global Compliance

Check out our resource center

Our experts have developed an extensive library of white papers, case studies, blogposts, and other informative resources.

PREMIER INSIGHTS

PREMIER INSIGHTS

WHITE PAPERS

WHITE PAPERS

WEBINARS

WEBINARS

VIDEOS

VIDEOS

PODCASTS

PODCASTS

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