NEW WEBSITE PROVIDING FREE GUIDANCE ON COUNTRY-SPECIFIC NIS REGULATIONS :

I’d like to introduce you to our new (hot off the press!) website ‘nis-regs.com’. The NIS REGS website provides you with entry-level information on the start-up requirements for prospective non-interventional studies (also known as…observational studies, registries, and post-market surveillance studies etc etc etc…)^{1, 2}.

The obvious question is ‘why did you create this?’ Simply put, it’s very difficult to find any information about how to run non-interventional studies. The relevant information has a tendency to be buried within clinical trial regulations and guidelines or hidden in obscure sections of government and research ethics committee websites (visualise dusty filing cabinets that are rarely opened).

If we continue the visual theme, real world research (RWR) can be seen as the ‘gold rush’ of clinical research. Why? Every day we read about more real world data collaborations^{3, 4}, companies creating deep tech tools for mining real world data and landing significant VC funding^{5, 6, 7}. Despite all this, there is a still a significant barrier to entry when it comes to gathering the real world data needed to generate real world evidence. That barrier is the black hole/ voodoo magic otherwise known as ‘NIS Regulatory Requirements’.

There are many myths out there, which go along the lines of…”there are no regulations for NIS”…”we only need approval from a central IRB in the USA to cover our global study”…”this isn’t really research so we don’t need any approvals”…

The reality is that non-interventional studies are regulated, but unlike clinical trials, there currently isn’t any standardisation or regional harmonisation. The end result is that every country has their own procedures and regulations for governing NIS.

So, that’s the ‘doom and gloom’ bad news. The good news is that we are actively working to remove these barriers to entry and making it easier and simpler to find and understand these regulations. Why us? We’ve been providing NIS regulatory solutions since 2009 through various companies (CHCUK and Phoenix-RWR), which means we have the experience, know-how and insights to ensure we give you credible guidance^{8, 9}.

The NIS REGS website is our free offering to help get you past the initial hurdle of knowing what to do and where to look. In the near future we’ll be releasing the RWR REGS website which is significantly more comprehensive and not only gives you detailed support on what you need to know and do, but also keeps you updated on what’s changed and what it means to you…watch this space!

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