As the complexity of clinical trials increases, so do the risks of quality issues, resulting in longer resolution times and higher costs. These risks can significantly impact a study’s operational success, making it more difficult to recruit patients and generate reliable results.

Our Risk-Based Quality Management (RBQM) is built on a foundation of industry-leading expertise and a deep understanding of the latest ICH E6(R2) guidelines for Good Clinical Practice (GCP) guidelines and regulatory requirements throughout all elements of a study.

Key Components of ACE Research RBQM

  • Risk Evaluation,
  • Risk Control,
  • Risk Communication,
  • Risk Review,
  • Risk Reporting.
US FDA Review Cycle Failure

Between 2000 – 2012 were due to quality issues.

Our team of experienced professionals provides a range of quality management services:

  • Standard operating procedures (SOPs) that outline the specific processes and procedures that should be followed in conducting your trial.
  • Quality assurance (QA) processes to ensure your trial is being conducted in accordance with the study protocol, SOPs, and GCP guidelines.
  • Quality control (QC) processes to ensure that the data collected is accurate and reliable.
  • Training programs to ensure compliance and roles and responsibilities, as well as the requirements of the trial.
  • Auditing and monitoring programs to ensure that the trial is being conducted in accordance with protocol and GCP guidelines.
  • Corrective and preventive action (CAPA) procedures to address any issues or deviations from the SOPs or GCP guidelines.

Leveraging our QMS ensures the quality, integrity, and reliability of your clinical research data, and ensures the rights and well-being of study participants are well protected.

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