Clinical Trial Solutions

Our Quality Assurance

Quality • Compliance • Assurance

We live & breathe quality

Our Quality Management System is based on Good Clinical Practice (GCP) quality guidelines, regulations, principles and requirements (GxP). Assurance is everything. Our deep experience in hosting audits and regulatory inspections is a key element in ensuring participant safety and data integrity. Quality is built into our systems, processes and staff training, with Standard Operating Procedures (SOPs) to define and structure all systems and processes, and all staff receiving training in GCP.

Ready to Use Data

Results matter. We deliver the highest quality data with all of our clinical trials, supporting international regulatory applications, including US Investigational New Drug (IND), Food and Drug Administration (FDA), and European Medical Agency (EMA) submissions.

We also measure up against stringent regulatory standards, including:

  • International Council for Harmonization Good Clinical Practice (ICH GCP).
  • Food and Drug Administration (FDA).
  • European Medicines Agency (EMA).
  • Brazilian Health Surveillance Agency (ANVISA).

Recent Audits

Our independent audit performance history spans over 200 sponsor and CRO audits. We have hosted multiple positive regulatory inspections by international authorities, including:

  • 28 audits conducted at Nucleus Network in 2019.
  • Three U.S. Federal Drug Authority (FDA) regulatory inspections in 2017, 2012 and 2008.
  • European Medicines Agency (EMA) regulatory inspection in 2017.
  • Brazilian National Health Surveillance Agency (Agência Nacional de VigilânciaSanitária, ANVISA) in 2012.
  • More than 200 research-sponsor audits.

Our quality assurance team conducts ongoing audits for all critical vendors to ensure compliance with high standards.