ABOUT 2RICHARDS

Independent clinical quality advice, grounded in experience.

2Richards is the independent clinical quality practice of Richard Reeve, providing pragmatic advice on GCP, sponsor oversight, quality systems, inspection readiness and the governance of emerging technology in clinical development.

Richard Reeve, MSc, MRQA

Richard has worked in clinical research since 1991, beginning in clinical data management and clinical operations before moving into GCP quality assurance and senior quality leadership roles.

His experience spans pharmaceutical, biotechnology and CRO environments in Europe and the United States, with responsibility for global GCP audit programs, quality systems, sponsor oversight and regulatory inspection readiness.

Since establishing his independent consulting practice, Richard has supported biopharmaceutical sponsors with the design and improvement of clinical quality systems, outsourced sponsor oversight, risk management and preparation for FDA, EMA and other regulatory inspections.

HOW I WORK

Quality is not improved by creating more process.

Clinical quality improves when organizations understand their responsibilities, concentrate controls where they matter, and can explain the decisions they have made.

My approach is deliberately practical: understand the evidence, challenge assumptions, distinguish important risk from procedural noise, and build systems that people can actually use.

35+ years in clinical research

70+ organizations supported

Global clinical development experience

Need an independent view?