Why IMU is a multi multi bagger, page-20434

Hi Footnort & All,

When a CRO (Contract Research Organisation) does the data cut, all trial sites have to have all data in, then it gets locked & cleaned. It’s not just a big thing for the CRO, but also for trial sites! Obviously data needs to be entered in a timely manner as per the trial protocol (which obviously I haven’t seen this one, but it’s a thing) but we also need to remember that patients are being screened, then treated at different times, there are multiple arms in Monotherapy and combination therapy with Keytruda.

Trial sites will have CRAs (Clinical Research Associates) or to simplify that a Monitoring visit on-site to go through all queries & check all source documents with the data entered. These are regular occurrences & it’s not unusual to be an all day thing, but prior to data lockouts, obviously this needs to be complete. There is also the possibility of FDA audits on trial sites as well, just like they do with drug companies & manufacturers.

Not only DISRUPTIVE but EXPENSIVE & very time consuming! Everything has to have i’s dotted & t’s crossed so to speak. Events during the trial (ie cohort completed) will trigger these events, not because SH are hungry for information. Let’s get that straight right now, but hopefully we are due an update soon.

So this is just a little snapshot to consider with clinical trials. All that work at the coalface we don’t see right?

Take care All,
I don’t think it’s a matter of being right or wrong, many opinions here, & probably we base those on our own backgrounds & life experiences. Perfectly fine .