Amendment 1 2nd posting RFP-NIAID-DAIT-NIHAI2010032.pdf

Amendment #1 to RFP-NIAID-DAIT-NIHAI2010032 NIAID Division of Allergy, Immunology and Transplantation: Clinical Site Monitoring Center

Amendment to Solicitation No.: RFP-NIAID-DAIT-NIHAI2010032

Amendment No.: 1 (2nd posting – Questions 4 thru 10)

Issue Date: January 25, 2011

Effective Date:

Proposal Due Date:

January 25, 2011

February 22, 2011 at 3:00 P.M. local time

Issued By: David T. Lisle Contracting Officer

NIH/NIAID

Office of Acquisitions 6700 B Rockledge Drive Room 3112 Bethesda, Maryland 20892-7612

Point of Contact: MyLinh Pham, Contract Specialist phamm@exchange.nih.gov

Name and Address of Offeror: To All Potential Offerors

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of proposals HAS NOT been extended. Offerors must acknowledge receipt of this amendment. Failure to receive your acknowledgement of this amendment may result in the rejection of your offer.

SECTION 1 – QUESTIONS AND RESPONSES

This section of the amendment provides questions submitted by potential applicants/offerors and the responses provided by NIAID. The responses are offered for information only and do not modify or become part of this solicitation. This Amendment will be updated as needed to add further questions and their related responses. All potential offerors are advised to refer back to this Amendment # 1 for additional Questions & Answers.

Question 1: In regards to Option #3 Provision of Accessibility to a DAIT-WIDE CLINICAL RESEARCH INFORMATION SYSTEM. If this is implemented in year 3 of the contract period of performance our IT specialist would like to know if we are actually developing this Division-wide information system or if this system is already developed?

Response to Question 1: In the event that a DAIT-wide information system with multi-directional flows of key information between the Division and their collaborators is developed and implemented by DAIT during the contract period of performance, the Clinical Site Monitoring Center (CSMC) contractor would be responsible for:

• In collaboration with the DAIT-wide information system management and collaborators. establishing the provision of direct, automated access from their contract-generated data, report and other materials, stored in the CSMC Management and Reporting System to the DAIT-wide information system

• In collaboration with the DAIT-wide information system management and collaborators, developing/deploying accessibility mechanisms required to achieve direct, automated access from CSMC information system(s) to the DAIT-wide information system, in accordance with specification(s) that would be provided by the DAIT Contracting Officer Technical Representative. (COTR).

Question 2: Would our IT specialist be helping with the accessibility mechanisms for automated access?

Response to Question 2: Yes, please refer to prior answer.

Question 3: It would be useful information to a bidder to know what commercial off-the-shelf (COTS) system is currently being used, since this might be the system that the bidder would propose in order to make a transition smoother. Could DAIT please provide the name of the COTS system currently being used to manage this information.

Response to Question 3: The NIAID did not make information about any systems currently being used by contractors to fulfill any portion of this requirement available in the subject solicitation because the NIAID has no intent of transferring any current systems for use under the anticipated new contract award. All offerors must propose a system that meets the requirements of the solicitation without regard to any systems currently in use.

The central intent of requiring commercial and off-the-shelf software is to avoid the risks and costs associated with interfacing with and migrating data from proprietary, undocumented, and/or unsupported systems. Within the context of the RFP, "commercially available" refers to hardware and software that:

• Is pre-packaged and off-the-shelf (i.e. not developed specifically or solely for use under the CSMC contract)

• Can be purchased or licensed from one or more vendors with a pre-existing presence in the marketplace

• Is available to, and used by, other governmental and private industry users

• Is regularly updated with bug fixes and enhancements

• Has maintenance and support available from the vendor and/or third-parties.

If the cost of licenses and maintenance are included the CSMC contract, they should be transferrable to the Government.

Question 4: The QA/QC plan due with the Technical Proposal (Attachment 5, page 5, E.), or is it to be submitted within 6 weeks of the contract effective date (Attachment 3, page 10, 1.a)?

Response to Question 4: Offerors should submit standard (non-DAIT specific) QA/QC plans which have been developed through the course of normal business performing quality assurance/control with the proposal. Upon award, the successful offeror would then comply with the Statement of Work (SOW) by fulfilling the contract-specific QA/QC plan requirement.

Question 5: The QA/QC plan will ensure that the conduct of all contract activities complies with domestic and country-specific regulations governing human subject research, GCP and ICH guidelines, and DAIT policies and procedures (Attachment 3, page 10 E.1). When is the offeror provided access to DAIT policies and procedures? How is access provided?

Response to Question 5: The DAIT COTR will ensure that pertinent policies and procedures of DAIT, the ITN and other DAIT-supported clinical research programs are provided to the Contractor in a timely manner and condition such that the successful awardee may comply with the requirements of Attachment 3, Section 3., I., 1. Initial Transition, paragraph b.

Question 6: Attachment 6, page 2-3 - The left hand column header say “General Technical Cost Assumptions (annual). Are these the numbers to used in developing the cost proposal or should the figures presented in the center and right column be added?

Response to Question 6: All of the information in this section is pertinent in providing a profile to potential offerors of the anticipated clinical site monitoring activity that should be expected from the contract effective date and throughout the base period (e.g., contract term) of performance. The “General Technical Cost Assumptions (annual)” column is inclusive of the “Ongoing” and “New” activities columns. The “Ongoing” and “New” columns are supplementary and provide offerors with more detailed information pertaining to the information provided in the “General” column.

Question 7: The Statement of Work states that monitoring shall be provided in the US, Americas, the UK, Western Europe and Australia. Costs vary significantly between these countries. For costing purposes can a breakdown of sites/countries or a uniform cost assumption be provided?

Response to Question 7: Please see Attachment 6, Section 3 for cost assumptions. Currently at least 95 per cent of the clinical site monitoring activity involves sites located in the U.S. For the remaining activity for purposes of providing offerors with a snapshot of international site locations to date, ordered by more common to least: the U.K; Australia; Canada; Mexico.

For additional representative site information, please see Attachment 7, Section IIA, which provides you the resources to identify existing site locations.

Due to the unknowns inherent in the research which may result in sites requiring clinical site monitoring, DAIT is unable to provide exact numbers beyond the assumptions already provided in Attachment 6 regarding country-specific site locations for cost proposal purposes. All offerors have equal access to the technical and cost assumptions provided in the RFP for proposal preparation purposes and should rely upon their knowledge and expertise in providing clinical site monitoring in developing a proposal (technical and business) that best represents their understanding of the requirements. All proposals will be evaluated according to the award factors described in Section M of the RFP.

Question 8: Is any of the face to face training to be conducted outside the US. If so, in which countries?

Response to Question 8: Please refer to Attachment 6, page 3 and response to question 2 concerning domestic and international estimates.

Question 9: Attachment 6, pg 2 provides an assumption of 1 new Phase II grant per year. Attachment 7 does not list any grants. Are there current grants which are to be supported, and if so, how many sites and where.

Response to Question 9: The final paragraph of the Background and Introduction of Attachment 3states, “…expand the scope of clinical site monitoring services provided to include…clinical research studies conducted under grants…” Attachment 7 provides additional information relating to current DAIT-support clinical research programs. The assumptions in Attachment 6 take into consideration not only the current activities, but the anticipated expanded activities to be covered by the eventual contract award.

Question 10: The link for attachment 18 (Commitment to Protect Non-Public Information Contractor Agreement) in the RFP does not work, do you have another link we can use or can you give us more instructions on how to access it?

Response to Question 10: The updated link is http://ais.nci.nih.gov/forms/Non-Disclosure_Form.pdf

Amendment #1 to RFP-NIAID-DAIT-NIHAI2010032