CONTEXT: Commercial announcement of a tie up between TriNetX and Takeda to develop the latter’s use of RWD in their overall trail design strategy. IMPACT: Low READ TIME: 1 min Continue Reading
CONTEXT: Commercial announcement of an RWE report updated for 2020 to 2030 claiming to cover a wide range of information about providers of RWE services and future trends in RWE. Continue Reading
CONTEXT: It seems that having Real-World Data (capitalised for emphasis) alongside your traditional clinical data at a poster presentation now adds weight to the overall message. RWR is the must-have Continue Reading
CONTEXT: Commercial announcement mirroring the developing trend in pulling together RWE data sources and analytical capabilities in response to the regulatory need for more granularity to assess the safety, health, Continue Reading
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
IMPACT: Taking insulin and a GLP-1 agonist significantly increases the ability of achievement stable blood sugar levels READ TIME: 2 mins * 1. “Sanofi’s Soliqua combines an insulin with a Continue Reading
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
Quick Notes: CONTEXT: Japan, Real-World Data IMPACT: Acceptability of RWD in Regulatory Submissions Time to Read = 2 mins Quotes from Source: 1. “TOKYO — Japan’s health ministry will issue Continue Reading
Quick Notes: *Within the report the “conditional marketing authorisations” and “monitoring in real-life” are the “go to” section to see what the post-authorisation obligations were and what the EMA is Continue Reading
