Amendment_2_-RFP--NIAID-DMID-NIHAI2015043.pdf

Amendment 2 February 4, 2016 RFP-NIAID-DMID-NIHAI2015043 Page 1 of 7

RFP-NIAID-DMID-NIHAI2015043

Amendment #2

“Clinical Research Operations and Management Support (CROMS)”

Amendment Issue Date: February 4, 2016

Proposal Due Date/Time: March 10, 2016 at 12 noon EST

[Unchanged]

Issued By: Erin Felent Contracting Officer

OA/DEA/NIAID/NIH/DHHS

Offerors must acknowledge receipt of this Amendment on each copy of the proposal submitted.

Failure to receive your acknowledgment of this Amendment may result in the rejection of your proposal.

The hour and date specified for receipt of proposals HAS NOT been extended.

This Amendment 2 is to provide questions and responses received in reference to RFP-NIAID-DMID-

NIHAI2015043.

Section of

RFP

Page No. Question Response

b. Technical Proposal Instructions

73 1. Is the proposal itself required to be 508 compliant?

1. Please refer to Part IV, Section L, 2.

Instructions to Offerors, a. General Instructions, 2. Authorized Official and Submission of Proposal.

Attachment 5 Section 3, 1A

Attachment 5, Page 1-2

2. Can the Government identify the items in 1A that pertain solely to the initial transition in order that offerors can categorize these costs as part of Option 10? In particular, items 1A1, 1A2, 1A3, 1A4, 1A5, 1A8, 1A9 appear to pertain only or primarily to the initial transition.

2. Please refer to the SOW Option 10 Initial Transition which outlines the Contractor responsibilities and activities for this Option when reviewing Attachment 5 Additional Business Proposal Instructions and Uniform Cost Assumptions, Section 3, which is for cost estimation purposes only.

Actual amounts may differ from the figures provided in Attachment 5. NIAID will evaluate each proposal against the assumptions provided in the RFP to ensure each proposal uses the same assumptions and figures. All assumptions are for a period of one year.

RFP-NIAID-DMID-NIHAI2015043 Page 2 of 7

Page No. Question Response

Attachment 5 Section 3, 1A

Attachment 5, Page 1-3

3. Other than “ongoing activities" that are part of the initial transition only, should offerors assume that all the 1A activities described recur each contract year?

3. Please see response to question 2. The Offeror should refer to the SOW when reviewing Attachment 5 for how to propose.

Attachment 5 Section 3, 1A, 1B

Attachment 5, Page 1-3

4.Are the uniform cost assumptions meant to require consistent level of efforts across the Base and Options 1 -6 or is the implication that the LOE will increase each year as new trials are added at a rate faster than trials are closed out? If the number of trials increases over the years, how does this relate to the consistent 101.6 FTEs specified in B.2 for each year?

4. All amounts provided in Attachment 5 Additional Business Proposal Instructions and Uniform Cost Assumptions, Section 3 are for cost estimation purposes only.

Actual amounts may differ from the figures provided in Attachment 5. NIAID will evaluate each proposal against the assumptions provided in the RFP to ensure each proposal uses the same assumptions and figures. All assumptions are for a period of one year.

Attachment 3 Section H

Attachment 3, Page 7

5. Please confirm that the data management of actual clinical data is outside the scope of this contract.

5. No, it does not include management of clinical data.

Please refer to Part I, Section H, Article H.13. Information and Physical Access Security, D. Additional NIH Requirements, 1., a. Information Type – Mission Based Information

Attachment 5;

Section 3, 1)A.9)

Attachment 5, Page 2

6. Are the 3200 SAE documents already in a safety data management system or will those need to be entered by the new contractor? Will a new contractor have access to document metadata to assist with the migration?

6. All amounts provided in Attachment 5 Additional Business Proposal Instructions and Uniform Cost Assumptions, Section 3 are for cost estimation purposes only.

Actual amounts may differ from the figures provided in Attachment 5. NIAID will evaluate each proposal against the assumptions provided in the RFP to ensure each proposal uses the same assumptions and figures. All assumptions are for a period of one year.

Attachment 3:

Section F.e

Attachment 3, Page 5

7. Will the contractor be responsible for preparing and submitting the reports directly to regulatory authorities or will the contractor submit reports to a Regulatory Services contractor?

7. Reports will not be submitted directly to regulatory authorities.

Please refer to Section F.2, b. Other Reports and Deliverables, Item 25.

Please also refer to Attachment 3, Statement of Work, F. Safety Monitoring, 1.e.

RFP-NIAID-DMID-NIHAI2015043 Page 3 of 7

Page No. Question Response

Attachment 3:

Section I.f.2

Attachment 3, Page 8

8. Some of the conditions surrounding data exchange with and/or from the N-CRMS is dependent on the timetable for completion of the N-CRMS. Is this system complete now? Or what are the timelines around its expected completion?

8. Attachment 3, Statement of Work, I.

CROMS Information Systems, f. remains relevant.

Please refer to Attachment 3, Statement of Work, I. CROMS Information Systems, f.

for further information.

Attachment 3:

Section F.c,d

Attachment 3, Page 5

9. F.c indicates that the triaging of SAE Report information must be performed 24 hours a day, seven days a week. F.d indicates that an evaluation of SAE Reports are due within 1 business day.

Must offerors include staffing to triage reports on a 24/7 basis?

9. The offeror should propose an infrastructure in support of Attachment 3, Section F. Safety Monitoring, 1c and 1d;

and Attachment 5, Section 3.

Attachment 3 Attachment

10. Translations are required in the scope yet no uniform cost assumption was given for translations. Is there a uniform cost assumption you can provide for the type and number of documents that will need translation?

10. Please refer to Attachment 5:

Additional Business Proposal Instructions and Uniform Cost Assumptions as written to be used by all offerors in preparation of the Business Proposal.

… … 11. Can you please provide a listing of the Government Furnished Property that is being offered for this opportunity?

11. Please refer to Section L, 2, c, 10. Other Administrative Data, a.3. Government- Furnished Property, on Page 82.

Attachment 5, Section 3.1.B

Attachment 5, Page 3

12. Is clinical site monitoring plan development required for the 45 new clinical trial protocols that will be initiated in each year of the contract period of performance?

12. All amounts provided in Attachment 5 Additional Business Proposal Instructions and Uniform Cost Assumptions, Section 3 are for cost estimation purposes only.

Actual amounts may differ from the figures provided in Attachment 5. NIAID will evaluate each proposal against the assumptions provided in the RFP to ensure each proposal uses the same assumptions and figures. All assumptions are for a period of one year.

… … 13. Could you please provide a description of the current infrastructure dedicated to

DMART?

13. Please refer to Attachment 5:

Additional Business Proposal Instructions and Uniform Cost Assumptions as written to be used by all offerors in preparation of the Business Proposal.

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Page No. Question Response

… … 14. Could you please provide a description of the current infrastructure dedicated to DMID CROMS website?

14. Please refer to Attachment 5:

and Uniform Cost Assumptions as written to be used by all offerors in preparation of the Business Proposal.

… … 15. How many users are served or transactions are offered by the current DMART infrastructure in a given timeframe?

15. Please refer to Attachment 5:

and Uniform Cost Assumptions as written to be used by all offerors in preparation of the Business Proposal.

… … 16. How many users are served or transactions are offered by the current DMID CROMS infrastructure in a given timeframe?

16. Please refer to Attachment 5:

and Uniform Cost Assumptions as written to be used by all offerors in preparation of the Business Proposal.

… … 17. How many active change requests on DMART do you expect in 2016?

17. Please refer to Attachment 5:

and Uniform Cost Assumptions as written to be used by all offerors in preparation of the Business Proposal.

… … 18. How many active change requests on DMID CROMS website do you expect in 2016?

18. Please refer to Attachment 5:

and Uniform Cost Assumptions as written to be used by all offerors in preparation of the Business Proposal.

c. Business Proposal Instructions

82 19. Are there any other Government furnished property to be received other than the legacy data, legacy source code and legacy object code?

19. No.

RFP-NIAID-DMID-NIHAI2015043 Page 5 of 7

Page No. Question Response

… … 20. Is there a version control system for the source code allowing to electronically receive ongoing changes and in progress branches at the time of execution?

20. Please refer to Attachment 5:

and Uniform Cost Assumptions as written to be used by all offerors in preparation of the Business Proposal.

… … 21. What is the set of legacy code languages used for both DMART and DMID?

21. Please refer to Attachment 5:

and Uniform Cost Assumptions as written to be used by all offerors in preparation of the Business Proposal.

… … 22. Are there any other systems that the contract awardee will be expected to support and maintain? If so please list and briefly describe these systems.

22. Please refer to Attachment 5:

and Uniform Cost Assumptions as written to be used by all offerors in preparation of the Business Proposal.

Attachment 5, Section 3.1.A.8

Attachment 5, Page 2

23. Are all 700 boxes of essential regulatory documentation at a commercial location? If so, please provide the name of the location.

23. Please refer to Attachment 5:

Additional Business Proposal Instructions and Uniform Cost Assumptions as written to be used by all offerors in preparation of the Business Proposal.

… … 24. Regarding clinicaltrials.gov, what number of studies should we estimate will close each year?

Can we assume that the number of studies that are closing each year are also the number of studies that will need results posting?

24. All amounts provided in Attachment 5 Additional Business Proposal Instructions and Uniform Cost Assumptions, Section 3 are for cost estimation purposes only.

Actual amounts may differ from the information provided in Attachment 5.

NIAID will evaluate each proposal against the assumptions provided in the RFP to ensure each proposal uses the same assumptions and figures. All assumptions are for a period of one year.

… … 25. Will DMID or their other partners be responsible for any additional analysis or authoring or table generation that is required for clinicaltrials.gov results posting?

25. Please refer to Attachment 5:

Additional Business Proposal Instructions and Uniform Cost Assumptions as written to be used by all offerors in preparation of the Business Proposal.

RFP-NIAID-DMID-NIHAI2015043 Page 6 of 7

Page No. Question Response

Attachment 5, Section 3, 1)B.4)Training Activities b.

Attachment 5, Page 5

26. Will these meetings occur annually? How many participants will be involved? How many will require air travel?

26. All amounts provided in Attachment 5 Additional Business Proposal Instructions and Uniform Cost Assumptions, Section 3 are for cost estimation purposes only. Actual amounts may differ from the information provided in Attachment

5. NIAID will evaluate each proposal against the assumptions provided in the RFP to ensure each proposal uses the same assumptions and figures. All assumptions are for a period of one year.

Section L – Clause 1.

General Information, Part d. Level of Effort

55 27. Are offerors being asked to bid 101.6 FTEs per year for purposes of bid comparability or are Offeror’s free to deviate from the Government’s stated FTE requirement?

27. NIAID will evaluate each proposal against the assumptions provided in the RFP to ensure each proposal uses the same assumptions and figures. As stated on page 55-56 of the solicitation, Offerors are to assume 101.6 FTEs per year, with a total possible yearly maximum of 127.60 FTEs based on the exercise of Options.

Section L – Clause 1.

General Information, Part d. Level of Effort

55 28. Reference is made to numbers of “FTEs”. Typically, LOE is specified as quantity (ies) of hours, to help ensure uniformity of pricing (and reporting of actual LOE delivered in resultant contracts). Please clarify/confirm how many hours does NIAID consider as 1 FTE:

e.g., is it a “direct work year” (e.g.

1,840, 1,880, etc. hours), or 2,080 hours (a measure of a full calendar year of effort @ 52 weeks x 40 hours)? Alternatively, please consider restating the LOE as hours rather than FTEs.

28. NIAID will evaluate each proposal against the assumptions provided in the RFP to ensure each proposal uses the same assumptions and figures. As stated on page 55-56 of the solicitation, Offerors are to assume 101.6 FTEs per year, with a total possible yearly maximum of 127.60 FTEs based on the exercise of Options.

Offerors should indicate the number of hours in their direct work year that is used as a full time equivalent.

Attachment 1, Item II.B.1.

Attachment 1, Page 2 (See RFP Amendment 1)

29. Reference is made to several items not included in the page limitation. In addition to those items, the below items/sections are generally not counted towards page limits. Please

29. Please refer to RFP-NIAID-DMID- NIHAI2015043 Amendment #1 “Clinical Research Operations and Management Support (CROMS)” Amendment Issue Date: December 7, 2015, page 2 of 3, Technical Proposal, Page Limits are 300

RFP-NIAID-DMID-NIHAI2015043 Page 7 of 7

Page No. Question Response confirm that the below will also not count towards the page limits:

• Information and Physical Access Security

• HHS Section 508 Product Assessment Template

• Technical Proposal Cost Summary

• Summary of Related Activities pages including all appendices and attachments.

Attachment 5, Section 3, 1)A.16)

Attachment 5, Page 2

30. References 5 clinical protocols that will require Quality Review.

Please provide similar information for Item 1.B (New Protocol Activity); i.e., a Uniform Cost Assumption for the number of new protocols needing document Quality Review per year.

30. NIAID will evaluate each proposal against the assumptions provided in the RFP to ensure each proposal uses the same assumptions and figures. Attachment 5 activities and amounts are for cost estimation purposes only. Actual activities and amounts may differ from the information provided in Attachment 5.