Independent clinical quality advisory
Quality.
Judgement.
Evidence.
Practical thinking and independent advice on GCP, sponsor oversight, quality systems, inspection readiness and the changing role of technology in clinical development.
FEATURED PUBLICATION · 2026
Governing AI in GCP Clinical Development
Artificial intelligence is being used to support increasingly complex activities and decisions in clinical development. The question is no longer simply whether a human remains ‘in the loop’, but whether human involvement provides meaningful challenge, judgement and accountability.
Richard Reeve · 2Richards
What matters
2Richards works with biopharmaceutical sponsors on clinical-quality questions that are difficult, consequential, or simply benefit from an experienced independent view.
Sponsor oversight
Practical governance of outsourced clinical development, focused on sponsor responsibilities that cannot simply be delegated away.
Quality systems
Lean, risk-based quality systems that support the way an organization actually operates rather than creating process for its own sake.
Inspection readiness
Understanding the evidence, vulnerabilities and regulatory narrative before an inspector asks the question.
Emerging technology
Applying established GCP principles to AI, computerized systems, data governance and new ways of working.
Longer-form analysis and commentary on clinical quality, regulation and evidence generation: the things worth keeping after the LinkedIn feed has moved on.
Perspectives
FEATURED PAPER
Governing AI in GCP Clinical Development
A practical examination of credibility, accountability, Meaningful Human Challenge and how AI should be governed when it begins to influence decisions that matter.
Richard Reeve · 2026
DATA & TECHNOLOGY
Thoughts on the EMA Guideline on computerised systems and electronic data in clinical trials
Practical implications for sponsor responsibility, validation, metadata, audit trails and inspection readiness.
GCP & REGULATION
Reflections on FDA’s Informed Consent Guidance
Some practical thoughts on what the guidance means for consent, documentation and sponsor oversight.
ABOUT 2RICHARDS
Experience without the theatre.
2Richards is an independent clinical quality consultancy providing pragmatic, risk-based advice across GCP, sponsor oversight, quality management systems and regulatory inspection readiness.
The emphasis is simple: understand what matters, identify the real risk, and make decisions that can be explained and defended.
35+ years
in clinical research
70+ organizations
supported
Global
clinical development experience
START A CONVERSATION
Need an independent view on a difficult clinical-quality issue?
2Richards supports biopharmaceutical sponsors with strategic GCP advice, sponsor oversight, quality systems and inspection readiness.