She has a degree in nursing and lives in California
Who is Brenda Reese
100
# of paper CRFs per patient
What is 125
100
The % of source data verification (SDV) recommended in the proposal
What is 100%
100
He is the global studies manager on this study
Who is Pierre-Karl Fortier
100
GDC-0199 is being evaluated in combination with this drug
What is rituximab
200
The minimum amount of clinical monitoring experience that CRAs assigned to Roche/Genentech studies must have per our MSA
What is 12 months
200
% of FTE of PM in Asia-Pac
What is 40%
200
The type of monitoring approach proposed that allows Covance to evaluate the most critical aspects of the trials in order to identify trends across sites and escalate issues, allowing selective targeting of non/poorly compliant sites to effectively implement additional monitoring or training through on-site visits in a timely manner and ensure corrective action plans can be completed
What is targeted monitoring
200
True or false: there is no Roche-specific training matrix in place within Covance to train new Roche project team members on Roche SOPs
What is false
200
True or false - we said in the proposal that the protocol is well-designed
What is true
300
Of the 15 core team members assigned to the Anti-IL13 program, how many have GNE experience?
What is XX
LIZ CHECK THIS
300
Time associated w/ close-out visits
What is 6 hours
300
This is the number of 4-hour face-to-face Roche/Covance meetings costed for over the life of the study
What is 3
300
According to Mark Fisher, OPL, they are interested in hearing about efficiencies with this Roche role
What is a CTA
300
The most common CLL patient population
What are the elderly
400
These two team members both worked at Omnicare in 2008
Who are Dawn and Christopher
400
# of IND annual reports we will be providing
What is 0
400
True or false: 24 hour medical monitoring was included in our budget
What is True
400
She is the Genentech medical monitor attending bid defense
Who is Rebecca Ellstrom
400
In what region of the world is CLL rare?
What is Asia-Pac
500
Of the 15 core team members assigned to the new Anti-IL13 program, these are the team members that are currently involved in the existing Lute/Verse Anti-IL studies
Who are Brenda Reese, Dawn Rogers, and Stephen Caron
LIZ CHECK THIS
500
The # of completed patients in this study
What is 352
500
This is the recruitment rate (pts/site/mo) that available data indicates is realistic
What is 0.16 pts/site/mo
500
According to the client's website, this is "where Roche is going"