Avid Bioservices Inc (CDMO)

[ku]

CP I still think that the new hires are to manage the CRO. For example the new data management hire will work with the CRO to come up with

1)The way the data should be collected. For example the design of the data entry screens and the way they flow as far as the tx and required tests flow based on the schedule in the protocol.

2)The way the database tables or datasets are set up as far as the data fields and data types go

3) The data quality check plan which will tell the CRO to what to look for as far as the data discrepencies go.

4) The structure of the SAS datasets that will be trasfered for analysis.

The only thing that makes a study blinded is the treatment dataset with someone knowing what the treatment codes are and that dataset could be set aside. In a nut shell the new hires are to manage the work of the CRO from a distance. I believe PPHM is open to going it alone for Phase III and that is a mistake since it is going to take a long time while potential studies for other indications are sitting around. I really hope that I am wrong