Budget
These are the three milestones that a GSM is required to complete a budget review with the sponsor.
What is First Signed SOW, 50% Enrollment, End of Enrollment
Of the three clinical endpoints, this determines if the main result that is measured at the end of a study to see if a given treatment worked
What is Primary Endpoint?
Of the three clinical endpoints, only this type of endpoint can be tested at our Translational Biomarker Solution lab in Greenfield.
What is Exploratory Endpoint?
Name the 8 langagues that are offered free of charge for lab manual or SCG translations
What are Brazilian Portuguese, English,
French, German, Italian, Japanese, Mandarin Chinese or Spanish
This type of criteria may define testing that is not clearly indentified in the schedule of assessments.
What is Inclusion/Exclusion criteria?
When a study has been awarded, this document is used by ELMS to document the testing requirements with the third party lab?
What is ELW (External Lab Worksheet)?
These two fees are generated/calculated based on the number of patient visits, investigator sites, geographic regions, visits, lab services and specimen management groups, and study duration (months).
What is Protocol Initiation and Protocol Execution?
For IHC Tissue Preparation Services - this is the general rule of thumb per medical affairs assumptions for the number of slides to assume - if not provided by your client. (e.g. PD-L1)
What is 5 - (1 slide for H&E, 2 slide for each IHC test and 2 back-up slides)
Makes knowing the intended use of the assay critically important for EU patients.
What is IVDR?
There are 26 countries have exports timelines greater than 30 days. Name at least 5.
What are Argentina, Bolivia, Brazil. Chile, Columbia, Ecuador, Mexico, Paraguay, Peru, Venezuela, Australia, Bangladesh, New Zealand, Phillippines, Taiwan, Thailand, Vietnam, Albania, Armenia, Azerbajan, Belarus, Chad, Kazahstan, Russia, Ukraine?