Right, my only point was that systems should have been set up to prevent that kind of hold up from happening. Data should have been collected all along, validated all along, and when the last patient data is available then the whole data set should be release-able.
It wasn't Anavex's fault and it was far out of line for that CRO to be so slow
You are being mighty generous to Missling to automatically fault the CRO entirely (contractually unable to publicly give their side of the story) when most likely blame is to be shared among several entities. If you want to believe Missling's every word as gospel I would love to sell you a few things. Who hired the CRO? Who writes their checks? Who communicates with them about progress and problems? Do they have any responsibility?
What is the process to get to the final database lock? Patients come in for their final visits and there will be vital signs, physical exam, scales (ADAS-Cog, ADCS-ADL, etc), labs, AE review, medication accounting/dispensing etc.... at each site, the research coordinator (under the supervision of the PI) compiles the data and enters it into the electronic data capture software (i.e Imedidata, Rave -- all P2 and P3 studies have been digital x years). The CRO reviews the data and sends DCF's back to the site to provide clarifying statements if needed. Then, periodically the CRO sends a clinical research associate (CRA) to the site to find problems and correct them. This is a repetitive exercise as the study proceeds. Every 6 - 12 months, for most larger studies and all P3's I've done, the CRO will do database locks to make sure all sites are staying up to date. The CRO and sponsor communicate back and forth. If there was a problem, Missling knew about it well before November 28.
What might happen if a site is having trouble. A few years back, we lost 2 coordinators back to back. The sponsor for one more larger study worked with the CRO to send a temporary coordinator to do a handful of patient visits and entry until we had hired another CRC at our site. Near the end of studies, we get a couple emails a week announcing the impending database lock and to talk to them if we are going to have any issues. Emails let us know how many DCF's are left (even letting us know how other sites are doing). The CRO and sponsor will both contact sites that are lagging and try to get them to finish before the date. I have never heard of a database lock being missed by more than one week. Did Missling pick up the phone to talk to the PI? Did Missling release some funds to allow the CRO to provide more help if it was needed or was he still pinching every penny? He blamed the CRO for Avatar, blames the CRO for AD 2b. It's nice to know where the buck stops.
If indeed the database lock was 4-5 months late, blame can be shared among the site (PI/staff), CRO and sponsor/Missling
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