ICH E6(R3) is here, and with it, clinical teams are bracing for the impacts. Biotechs are being asked to develop clear and concise protocols, demonstrate oversight throughout the trial, integrate early risk planning, and monitor the trial using a risk-based approach. It’s a lot to manage, especially for small biotechs without a giant team.
Are there updates to R3 to consider? Yes.
Should it be a nightmare? Not if you can break down what’s real—and what’s fiction.
The good news: you don’t need to stress about having all the answers… but you do need a CRO who can zoom out, bring clarity, and get you where you want to be.
We should overload our trial with endpoints and assessments.
To avoid setbacks during your trial, engage your CRO early during protocol design. Rho starts with the end in mind, embedding quality from day one and helping you focus on what’s most important for your trial. Proactive planning also lowers your risk for site and patient burden.
I don’t need to provide oversight if I’ve transferred responsibilities to my CRO.
As a sponsor, you are ultimately responsible for the trial and the oversight of your vendors and partners, and regulatory agencies will want to see evidence that you are doing just that. Rho captures and tracks the right information to document your oversight during the drug development process. We’re here to guide you from beginning to end.
Thinking about risk mitigation is a one-time thing.
Risk mitigation under R3 isn’t just a box to check… it’s a mindset to adopt. Rho knows risk management is a dynamic process that must be monitored throughout the clinical trial lifecycle. Our quality by design approach can set the tone from the beginning, but we also monitor and adapt to unforeseen risks during the trial.
As long as the data are captured, we can figure out how to integrate the data later.
When you have integrated systems in your trial, you can streamline your data collection approach, find issues faster, and build consistency. Rho has evolving data integration tools that can help you see the full picture, so everyone is on the same page and can work efficiently, effectively, and confidently.
Your CRO should do more than just follow the new guidance… they should pitch in to get you ahead of it. At Rho, we are at-the-ready to navigate the adjustments that R3 may bring in the short-term, so your team thrives in the long-term. That’s the Cohesion Effect at work.