Attachment No. 7 - Responses to Potential Offeror Questions_Part 2_Final.docx

Attachment #7 - Responses to Potential Offeror Questions Part 2

FDA-RFP-116104

1. The CRA/Monitor- requires five years of experience in onsite monitoring and ten years of management experience in IND studies. A monitor with ten years of management experience may not have recent onsite experience of five years because the management of IND studies is of a higher work caliber than onsite monitoring. Can you confirm if the onsite experience is preferred to be a most recent experience?

A: This was a typo; The CRA/monitor does not require 10 years of management experience. Please see the document “Attachment No: 2_Revised as of Amendment #2”

2. In the RFP- the QMS is a requirement. However, the labor category to support the development of the QMS is not listed in the list of labor categories or the list of qualifications. Typically, the Manager, PI/Director, nor the CRA will be the developer of the QMS, although they will provide significant input. Can we add this labor requirement to the RFP, or will a specific Task Order be issued to develop this deliverable?

A: Offerors are permitted to whichever labor categories and labor mix they believe is best in order to perform the requirement. If QMS development is performed under this IDIQ, it will be issued as an independent task order.