Do half the features you wanted Do half the features you want. There is a temptation to go wild with generative AI. Do NOT forget that you still need users who will pay you money. Based on our very positive experience with Omdena and trying to figure out how to…

You can outsource your trip from Lyon to Paris to a cab driver. It will cost you over EU400 and take at least 4 hours. You can take the TGV, for EU25 and be there in 1 hour. The self-service solution is 64X more cost-effective but it requires infrastructure. In…

The real world of clinical R&D doesn’t look like this I was inspired to write this post by Kim Gueddes. I met Kim at Centrexion December 2019. Just before COVID. The work with Kim and Centrexion would later plant the seed for Riskgraph.ai …

The term security theater was coined by Bruce Schneier in his book Beyond Fear. The term became popular when describing airport security measures. For theater on a grand scale, you can’t do better than the audience-participation dramas performed at airports, under the direction of the Transportation Security Administration. … “Theater…

I am skeptical about this whole eSource revolution thing. I have been following a LinkedIn thread about CRIO announcement of integrating EHR with EDC and eSource. This should be the future direction of clinical data capture. But — eSource has been the future since 2011. Why is EHR-EDC-eSource not the…

It’s a long road to FDA with lots of twists and turns 5.2.1 A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. That is…

Risk assessment, as currently practiced in clinical trials, is dead. I’m not saying we need to eliminate risk management altogether as a concept, but it needs a complete overhaul to deal with clinical data risk in the 21st century. Our concept of risk as a static condition must evolve. Clinical…

Dr. Marty Makary is the chief of Islet Transplant Surgery at Johns Hopkins. His 2012 book “Unaccountable”, is a New York Times best-seller on how to make American healthcare more transparent and safer for patients. The book details the hazards of transparency done poorly and the reward of transparency done…

The end of the road for data managers Andrej Karpathy was Senior Director of AI at Tesla, where he led the computer vision team of Tesla Autopilot. He was a research scientist and a founding member at OpenAI, the developers of ChatGPT. We usually look at ChatGPT as an amazing…