Amgen Invests in Data Deal
Comments – Part of the growing trend for big pharma to secure bid data sources for their own use. A move in the right direction towards ‘regulatory grade’ RWE. READ Continue Reading
“InSilicoTrials: accelerating the uptake of simulation in clinical research – Medical Device Network”
CONTEXT: European initiative to explore “In-Silico” research. Not so much “Real World” as “Brave New World” utilising computer models to test safety and efficacy of medical devices. Hopefully this isn’t Continue Reading
FDA: Plan for Oversight with ML/AI in Medical Devices
CONTEXT: FDA publishing an action plan on AI in SAAMDs. China already ahead of the game in terms of how they have already enacted guidance on AI in SAAMDs, but Continue Reading
EMA to USE EMA Software for Real World Data
Comments – Part of the EMA’s continued commitment to RWE in support of medicinal product utilisation. When you see regulators investing in infrastructure like this, you know they are serious Continue Reading
AMGEN INVESTS IN BIG DATA DEAL – REAL WORLD EVIDENCE
COMMENTS: Part of the growing trend for big pharma to secure bid data sources for their own use. IMPACT: A move in the right direction towards ‘regulatory grade’ RWE, READ Continue Reading
Medical Device Innovation Consortium Releases Real-World Evidence Framework for In Vitro Diagnostics – Business Wire
Quick Notes: CONTEXT: USA, IVDs, RWE, Real-World Evidence Framework for regulatory decision-making for in vitro diagnostics (IVDs) IMPACT: step forward in providing the valuable information that IVD manufacturers and others Continue Reading
Aetion and Cegedim Health Data announce new partnership to power real-world evidence research in Europe – PRNewswire
EXPERT NOTES: CONTEXT: EU, Commercial RWD Data Source IMPACT: Access to EU RWD, drive cutting edge improvements in patient outcome Time Taken = 3 mins QUOTES FROM SOURCE: 1. “NEW Continue Reading
Contributed: Trials and tribulations – the new world of decentralized trials – Mobihealth News
EXPERT NOTES: CONTEXT: Decentralized Clinical Trials IMPACT: Enabling technology for ‘Decentralized Clinical Trials’ a.k.a ‘Virtual Trials’ Time Taken = 2 mins QUOTES FROM SOURCE: 1. “As mentioned earlier, COVID-19 has Continue Reading
Robots were dreamt up 100 years ago – why haven’t our fears about them changed since? – The Conversation UK
EXPERT NOTES: CONTEXT: Cool Shit REACTIONS: Expert 1: “We are all doomed…someone turned on SkyNet and the AIs became self aware.”Expert 2: “Nice human interest story”Expert 3: “Centaurs guys, … Continue Reading