Most organizations have now implemented ICH E6 (R3). Standard operating procedures (SOPs) are updated, systems adjusted and training delivered. But many sponsors, CROs and sites are now asking a tougher question: how mature is our implementation?
Being “done” is not the same as being inspection-ready. R3 implementation is not a one-time event – it is a progression from awareness to adoption and finally to embedded daily practice.
A simple maturity model
Benchmarking against peers can help you identify where you stand and where regulators will expect you to improve. R3 maturity is best seen as a journey – from initial adoption to embedded, inspection-ready practice.
You can think of R3 maturity in three broad stages:
- Initial: basic alignment with R3 wording and SOPs revised, but real-life practice still reflects R2. Risk-based thinking is inconsistent and teams are uncertain about expectations
- Managed: cross-functional teams conduct risk assessments, oversight is more proportional and key changes are integrated, such as protocol simplification, oversight, data governance and role-specific training. Inspectors see evidence, but consistency varies
- Optimized: R3 principles shape daily practice. Oversight, culture and competence are aligned. Staff explain their decisions confidently, critical-to-quality (CtQ) factors are tracked across the lifecycle and data governance is embedded. R3 is no longer a project, it is part of daily practice
Five dimensions that define maturity
Inspectors are not looking for more documentation – they are looking for reasoning and evidence. To benchmark your progress, consider these five key dimensions:
- Oversight and proportionality
Do you scale monitoring and QA to trial risk, or still apply a one-size-fits-all approach? How ready are you for regulatory questions? Are your decisions documented, justified and revisitable? Can you show why oversight was scaled the way it was and provide evidence of oversight beyond contracts?
- Protocol quality
Are protocols designed for feasibility and proportionality, minimizing site and participant burden? Can you prove that your risk assessments led to simplification rather than added complexity? Have you actively reduced unnecessary controls or steps?
- Critical-to-quality factors (CtQs)
Are CtQs defined early and tracked throughout the trial lifecycle? Are deviations analyzed and addressed? Do sponsors and investigators share a clear understanding of what is truly critical to quality?
- Data governance
Are systems validated with a risk-based approach? Can you demonstrate data integrity (accuracy, completeness and security)? Are data oversight responsibilities clearly defined in supplier contracts and SOPs?
- Culture and competence
Do people understand their R3 roles in protecting participants and data, beyond following SOPs? Are they confident in explaining decisions to inspectors? Is training tailored to their roles and practical in focus? Do cross-functional teams (QA, operations and investigators) collaborate effectively on risk assessments and decisions?
Moving forward with confidence
If your answer is, “we implemented R3, but we’re not sure if it’s good enough,” you are not alone. Many organizations are in the same position. Maturity is a journey, not a switch.
We have walked this road ourselves and support others to do the same. We know where organizations struggle and how to move beyond compliance into confident, inspection-ready practice. That is where targeted gap analysis, role-specific training and pragmatic SOP alignment can help turn an “initial” or “managed” setup into a truly optimized one.
Find out more – watch our latest webinar
In our latest webinar, “ICH E6 (R3): Are You Confident in Your Implementation?”, join our experts as they share lessons from our internal rollout, a real-world case study and insights into what inspectors are focusing on next.
Watch our on-demand webinar now.
You have implemented R3 – now ensure you are inspection ready
About SGS
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN:SW).
