Clinical Quality

Quality as it relates to clinical trials is an important concept. The Clinical Trial Transformation Initiative (CTTI)[1] defines quality as the ability to effectively and efficiently answer the intended question about the benefits and risks of a medical product (either therapeutic or diagnostic) or procedure, while ensuring protection of human subjects.  As a study sponsor, you are responsible for ensuring quality in your clinical trials. You want to be confident that your study is conducted under a clinical quality approach as codified in ICH-GCP (E6R2) and to ensure that it is:


  • Scientifically valid and ethically sound,
  • Protective of the safety, rights, and welfare of study participants,
  • Conducted by engaged, qualified study personnel,
  • Robustly monitored,
  • Collecting current, complete, and accurate data.

It is important to work with clinical affairs experts whose emphasis and devotion is to these fundamentals of quality.

At Hart Clinical Consultants, we have leveraged our expertise in the clinical monitoring space to take it to the next level. We provide an umbrella of quality services that apply to audit-preparedness for any kind of inspection. Our Certified Clinical Auditors have years of experience as study monitors that give HCC the capacity to perform BiMO-readiness activities with precise and accurate execution according to the applicable regulations and study plan. Our experts are versatile and can serve in an advisory capacity or play the role of a tough regulatory inspector, depending on your needs.


Being proactively prepared for an inspection leads to fewer findings, higher quality data, and ultimately helps streamline the path to your regulatory submission and approval. Audit preparedness helps mitigate common issues with informed consent, delegation of responsibilities and oversight, IRB non-compliances, and protocol violations before an inspection occurs. BiMO preparation audits specifically provide the benefits of tuning up your study files and clinical research teams to the requirements of an audit or inspection.

Specific services we offer:

  • Full study file review and audit-readiness services at various time points during your study
  • Sponsor-directed audits to assess specific study areas
  • BiMO preparatory audits at the end of key study time points, when an inspection is imminent or expected

[1] Definition from October 2008 presentation on CTTI by Dr. Rachel Behrman, CTTI Co-chair and then Associate Commissioner for Clinical Programs, FDA.

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