Amendment_1_-_RFP-NHLBI-CSB-AR-2016-19-CM_-_Final.docx.pdf

RFP No. NHLBI-CSB-AR-2016-19-CM Amendment - 1

SOLICITATION: NHLBI-CSB-AR-2016-19-CM

AMENDMENT: One (1)

TITLE: Clinical Studies Management and Support

EFFECTIVE DATE: November 22, 2015

ISSUED BY:

National Heart, Lung, and Blood Institute, NIH

Office of Acquisitions, CSB, OM

6701 Rockledge Drive, Suite 6042, MSC 7902

Bethesda, Maryland 20892-7902

Point of Contact: Cornelius Moore, Contracting Officer [E-mail – Cornelius.Moore@nih.gov]

The above numbered solicitation is amended as set forth below. The hour and the date specified for receipt of proposals has been changed to 3:00pm EST on December 22, 2015. Offerors must acknowledge receipt of the amendment prior to the hour and the date specified for receipt of proposals, by one of the following methods:

A. By acknowledging receipt of this amendment on each copy of the proposal submitted. Please note that this is the preferred method.

B. By separate letter or email which includes a reference to the solicitation and amendment number.

DESCRIPTION OF AMENDMENT

PURPOSE: To provide responses to questions submitted in response to the Request for Proposals (RFP).

All other terms and conditions of the solicitation remain unchanged.

END OF AMENDMENT

mailto:Cornelius.Moore@nih.gov

NIAMS RFP Number: NHLBI-CSB-AR-2016-19-CM Clinical Studies Management and Support

Questions

1. Is there an incumbent contractor currently performing the contract requirement? If so please provide the contractor name and contract number.

ANSWER: Yes there is an incumbent. KAI Research, Inc. Contract number

HHSN268201100041C.

2. Pg. 4. Article B.1 specifies, "the development of electronic systems to collect, maintain, and monitor adverse events for selected NIAMS clinical studies…" however that activity is not specified in the SOW (Task 11) - is the collection, maintenance, and monitoring of AEs for clinical studies via an electronic system a requirement for this RFP?

ANSWER: At this time, this is not a requirement of the RFP. The development of electronic systems to collect, maintain, and monitor adverse events was only used as an example in the solicitation and is not a required task under Task 11.

3. Pgs. 9 & 12 Project Management Plan. Please clarify if a Project Management Plan is to be submitted with the proposal and if so is it included in the specified technical page limit of 30 pages?

ANSWER: Yes, a draft plan is to be submitted with the proposal. The draft Project Management Plan shall not be counted towards the technical page limit.

4. In reference to page 15, please define the staff considered as key personnel.

ANSWER: As per the Request for Proposal, Key personnel staff members are those considered to be essential to work performance. An example of Key Personnel would be any proposed Project Director. Other personnel may or may not be proposed.

5. Article H.21 (page 31): Is it expected that clinical research data sets from NIAMS studies will be provided to the NHLBI Data Repository?

ANSWER: No, this requirement does not apply to the solicitation.

6. Pg. 48. Page and Formatting Limitations. Is a type/font such as Arial 11 point, single spacing acceptable?

ANSWER: Yes, that is acceptable.

7. In reference to page 48, Page and Formatting Limitations, please confirm that the substudy proposal section requirement does not apply to this solicitation.

ANSWER: Correct, it does not apply.

8. In reference to page 48, Page and Formatting Limitations, please confirm that: the Technical

Proposal Attachments (page 38), as well as the organizational experience, cover sheet, abstract, table of contents, personnel, facilities, equipment and resources, other consideration, schedule, other support, cost information, and literature sections do not count toward the Appendices 50 single-sided or 25 double-sided pages limitation.

ANSWER: The Technical Proposal Attachments as well as the others listed do not count towards the page limitation.

9. Page 48 of the RFP places a limit of 50 pages on the appendices. Please confirm that this limit does not include attachments (such as CVs, Section 508 PATs, etc.) associated with technical narrative sections that are exempt from the 30-page Technical Plan.

ANSWER: As specified in the RFP, page limitation does not include the attachments, cover sheet, abstract, table of contents, personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, and literature cited.

10. Pg. 48. Page and Formatting Limitations specifies, “The Technical Plan (objectives, approach, methods and procedures, and substudy proposal) of the technical proposal shall not exceed 30 single-sided pages or 15 double-sided pages.” Where are the requirements for the substudy proposal outlined in the RFP?

ANSWER: The substudy requirement does not apply.

11. Section L.2.a.6 entitled “Page and Formatting Limitations” under General Instructions

(page 48) indicates offeror Technical Plans should include a “substudy proposal section that shall not exceed 8 single-sided pages.” This is the only mention of a substudy proposal throughout the RFP. Please confirm this was included in error and there is no requirement for a substudy section.

ANSWER: Correct. There is no requirement for a substudy.

12. Section L.2.a.15 entitled “Past Performance Information” (page 51) states that offerors should include the last 3 contracts completed during the past 5 years and all contracts currently being performed in their Business Proposal. However, section L.2.c.7.d entitled “Pertinent Contracts” under the “Qualifications of the Offeror” section (page 76) specifies that offerors should include a listing of each related contract completed within the last 3 years or currently in process. Please clarify whether offerors should include all relevant contracts completed in the last 3 years or all relevant contracts completed in the last 5 years.

ANSWER: The following should be supplied, the last 3 contracts completed during the past 5 years as well as each related contract within the last 3 years or currently in process.

13. Section L.2.c.2 entitled “Proposal Cover Sheet” under the Business Proposal Instructions section (page 68) lists the information that should be included on the Business Proposal cover page. The subsequent section L.2.c.3 entitled “Certified Cost or Pricing Data” (page 68-70) lists additional information that should be included on the first page of our Business Proposal. Please clarify the discrepancies between these two sections and specify the information the Government requires on the Business Proposal cover page.

ANSWER: All the information requested in the two sections should be provided.

14. Pg. 52. 16. Information and Physical Access Security. Is the Section "Information Security" included in the page limitations? Is it permitted to be included as an Appendix?

ANSWER: The Information Security section is not included in the page limitations.

15. Pg. 67. 5. Electronic and Information Technology Accessibility, Section 508

Compliance. Is the Section "Section 508 Compliance" included in the page limitations? Is it permitted to be included as an Appendix?

ANSWER: This information is not included in the page limitation.

16. Does Attachment 7, HHS Section 508 Product Assessment Template, count against the Appendices page count provided on page 48 of this Request for Proposal?

ANSWER: This information is not included in the page limitation.

17. Pg. 77. Business Proposal Instructions, 11 c. Task 4 states that 6 trials per year will require visits by 2 staff, should we assume these are 1 day visits? ANSWER: Yes, these should be assumed to be 1-day visits.

18. Page 77, bullet c. For Task 4, we are to perform study/site assessment visits for “up to 6 trials per year.” How many visits per trial per year should offerors assume? How many sites per trial should we assume?

ANSWER: The Offeror should assume one study/site assessment visit per trial, with a possibility of a follow-up visit. For budgeting purposes, please assume that there would be a second follow-up visit for 3 out of 6 trials. The visit would only take place at the primary/lead study site/institution and therefore the assumption should be that visits are only done at a single site, even though the study may be conducted at multisites. Depending on the nature of the study/site assessment, it is possible that the NIAMS may request the visit to take place at a site other than the primary/lead study site/institution.

19. Page 77 bullet e. For Task 6, we are to provide statistical review and consultation for 10 studies per year. Task 6 includes the following components for review/comment: SAPs, statistical report, conducting analyses, consulting, and manuscript/presentation review. The different components will require different levels of effort. Should we assume 10 studies per component? If not, how should the 10 studies be allocated across components?

ANSWER: Please assume that 2 out of 10 studies will require component (a), 3 out 10 will require component (b). The remaining 5 studies will be spread over the other components (c-e).

20. In reference to page 77, items h. and i., can you confirm that NIAMS is anticipating 35

DSMB/OSMB teleconference meetings and 5 DSMB/OSMB in-person meetings per year?

ANSWER: Yes, that is the correct assumption.

21. The budget assumptions (page 77) provided in section L.2.c.11.h state that “NIAMS anticipates 20 active NIAMS appointed DSMBs/OSMBs per year” and that each monitoring board will meet twice per year (40 total meetings per year). The subsequent line item assumption (L.2.c.11.i) tells offerors to assume 5 DSMB/OSMB meetings will be held each year as face-to-face meetings. Based on these assumptions, should offerors assume that 35 DSMB/OSMB meetings per year will be held via conference call?

ANSWER: Yes, that is correct.

22. In reference to page 77, item c., can NIAMS indicate the number of sites that will require study/site assessments visit per year?

ANSWER: Please assume that 6 trials will each have a single-site requiring study/site assessment. Please also include 3 additional follow-up visits.

23. Please clarify: are contractors expected to send monitors on-site? If so, please indicate the

Uniform Cost Assumption and the location(s) monitors are expected to travel to.

ANSWER: The NIAMS expects that its Investigators will build in a plan for onsite monitoring and include it in the study budget. However, there are times when this may be overlooked or not properly budgeted for and may require the NIAMS support to implement through its Contractor. The NIAMS anticipates this will happen in some cases. Please assume 2 onsite clinical monitoring visit per year for up to 2-days to take place by the Contractor’s CRA and the location to be Chicago, IL.

24. In reference to page 77, please provide travel uniform cost assumptions for item c. Task 4, item

g. Task 8, and item j. Task 10.

ANSWER: Item c., Task 4: The Offeror should assume one study/site assessment visit per trial, with a possibility of a follow-up visit. For budgeting purposes, please assume that there would be a second follow-up visit for 3 out of 6 trials. The visit would only take place at the primary/lead study site/institution and therefore the assumption should be that visits are only done at a single site, even though the study may be conducted at multisites.

Depending on the nature of the study/site assessment, it is possible that the NIAMS may request the visit to take place at a site other than the primary/lead study site/institution.

25. In reference to page 79, Data and Safety Monitoring, please confirm that the requirement to include a Data and Safety Monitoring Plan does not apply to this solicitation.

ANSWER: Yes, that requirement does not apply.

26. Pg. 80. Section M.4 Evaluation of Data Sharing Plan. Is the requirement of a Data Sharing Plan ("plan for sharing of final research data") applicable for this proposal?

ANSWER: No, this requirement does not apply to this solicitation.

27. In reference to page 80, Evaluation of Data Sharing Plan, please confirm that the requirement to include a plan for the sharing of final research data does not apply to this solicitation.

ANSWER: No, this requirement does not apply to this solicitation

28. Section M: 2a. This section requires offerors to produce a Data and Safety Monitoring Plan

(DSMP) for proposed clinical research and states this plan will be evaluated as “acceptable” or “not acceptable.” However, the Clinical Studies Management Support contractor will not propose any clinical research studies; all research will be proposed by extramural investigators, who will have responsibility for producing the DSMP. Please confirm that the submission of a DSMP is not required as part each offeror’s response.

ANSWER: Yes, that requirement does not apply.

29. Task 1, Contract Start-Up, Administration and Overall Project Management, requires the contractor to write Standard Operating Procedures (SOP). Is the contractor expected to develop project-specific SOPs?

ANSWER: Yes, that is correct.

30. In reference to Task 4 Study/Site Assessment, is the contractor expected to conduct more than one site assessment visit per investigational site per study? Is a Monitoring Plan required or expected for site assessment visits? Will the contractor be expected to conduct a review of source data against completed case report forms (CRFs) during these assessment visits?

ANSWER: Typically, study/site assessment visits are only conducted once per study at the primary/lead study site/institution, however, depending on the nature of the study/site assessment, the NIAMS may request that the visit may take place at a site other than the primary/lead study site/institution. A total of 6 study/site assessments per year are expected and an additional second follow-up visit may be required for 3 out of 6 studies. The study/site assessment visit is not meant to be the same thing as a clinical site monitoring visit. The purpose of this visit is to review clinical study site operations and facilities.

Depending on the nature of this visit, there may be a need to review clinical data and records to evaluate any problems or deficiencies noted with this process. There may be some source data verification against completed CRFs required.

31. Pg. 6. Attachment 3, Statement of Work. Task 4 Study/Site Assessment states “The

Contractor shall: b. Generate a study/site assessment report with findings from the assessment and recommended corrective actions. The report shall be delivered to the NIAMS staff and the COR within 5-working days of the visit.” To ensure that the most detailed report is delivered, is it possible to extend the 5 working days timeframe?

ANSWER: This is something that can be negotiated further when the study/site assessment is initiated by the NIAMS.

32. In reference to Task 4 Study/Site Assessment and Task 5 Risk-based Monitoring, is the

Contractor expected to conduct Monitoring activities?

ANSWER: Task 4 is not to conduct clinical monitoring visits. Task 5 may require some instances for monitoring by a CRA. The NIAMS expects that its Investigators will build in a plan for onsite monitoring and include it in the study budget. However, there are times when this may be overlooked or not properly budgeted for and may require the NIAMS support to implement through its Contractor. The NIAMS anticipates this will happen in some cases.

Please assume 2 onsite data monitoring visits (this could be 2 visits for a single study or 1 visit each for two separate studies) per year for up to 2-days to take place by the Contractor’s CRA and the location to be Chicago, IL for the UCA.

33. In reference to Task 5 Risk-based Monitoring, please confirm that in addition to generating a

Risk-based Monitoring Plan that on-site visits, as appropriate, will be conducted by the contractor for all studies for which a Plan is generated?

ANSWER: No, not all studies for which a plan is generated will require on-site visits. It is expected that 5 trials per year will receive a risk assessment. Please assume that 2 onsite data monitoring visits(this could be 2 visits for a single study or 1 visit each for two separate studies) per year for up to 2-days to take place by the Contractor’s CRA and the location to be Chicago, IL for the UCA.

34. In reference to Task 5, Risk-based Monitoring. The Contractor would need to receive periodic data transfers from the study database(s) in order to implement a risk assessment strategy that is up to current standards. Can NIAMS confirm periodic data transfers will be possible?

ANSWER: Currently, the NIAMS does not have a setup allowing data transfers from the study’s database. Please note that this task entails assessing risk and developing a monitoring plan with the potential for on-site data monitoring. It is expected that 5 trials per year will receive a risk assessment. Please assume that 2 onsite data monitoring visits (this could be 2 visits for a single study or 1 visit each for two separate studies) per year for up to 2-days to take place by the Contractor’s CRA and the location to be Chicago, IL for the

UCA.

35. Pg. 6. Attachment 3, Statement of Work. Please clarify if Task 5 - Risk Based Monitoring - is limited to assessing risk and developing a monitoring plan (Task 5.a and 5.b, respectively) or includes actual risk-based remote or on-site data monitoring for the anticipated 5 trials/year?

Task 5 indicates that monitoring may be requested by the COR, yet the business proposal instructions (pg. 77) state no travel will be required under this task area. If risk-based remote monitoring is expected will the NIAMS make study data available for risk assessment? If on-site risk-based clinical monitoring visits are anticipated please provide estimated number of visits per year and visit length, i.e., 1 day?

ANSWER: It is expected that 5 trials per year will receive a risk assessment. Risk-based remote monitoring is not expected. Please assume a total of 2 onsite data monitoring visits (this could be 2 visits for a single study or 1 visit each for two separate studies) per year for up to 2-days to take place by the Contractor’s CRA and the location to be Chicago, IL for the UCA.

36. Pg. 7. Attachment 3, Statement of Work. Task 6- Statistical Review and Consultation states that the contractor will provide statistical consultation but also conduct analysis. While the Business proposal assumptions (pg. 77) state that up to 5 studies per year will need this support it is not clear how many of those 5 are expected to be consultation and how many are expected to be conducting an actual analysis. Please clarify.

ANSWER: Please note that the business proposal instructions state that 10 studies will require statistical support. Assume that 2 out of 10 studies will require component (a), 3 out 10 will require component (b). The remaining 5 studies will be spread over the other components (c-e).

37. In reference to Task 8, Training, and Education, how many LMS users are anticipated?

ANSWER: Please assume 20-25 users.

38. In reference to Task 11, Information Management Systems, can NIAMS identify the systems in use that would transfer to the new contractor?

ANSWER: A database containing NIAMS clinical study information.

39. In reference to Task 12, On-Site Contractor Support, can NIAMS elaborate on the tasks performed by the person providing on-site support?

ANSWER: On-site contractor support may include but is not limited to; attending meetings with NIAMS Program Staff and Clinical Research Managers to discuss clinical study start-up tasks, safety monitoring, study documents reviews, and any other activities required to support NIAMS clinical studies. The Contractor will also be expected to attend any internal NIAMS meetings related to the management and oversight of clinical trials to facilitate meeting setup and recording of meeting minutes. It is expected that the Contractor’s presence on site will help to create a rapport with NIAMS staff to help facilitate the activities under this contract.

40. Section L.2.c.11 entitled “Business Proposal Instructions” (page 78) and Task 12 within the

Statement of Work (Attachment 3, page 13) specify that 1 Contractor staff member will work on-site in Bethesda 3 days per week (24 hours per week) to perform clinical research support activities. For costing and resourcing purposes can the Government provide a short position description or summary of day-to-day activities that will be required of the contractor’s on-site staff member?

ANSWER: On-site contractor support may include but is not limited to; attending meetings with NIAMS Program Staff and Clinical Research Managers to discuss clinical study start-up tasks, safety monitoring, study documents reviews, and any other activities required to support NIAMS clinical studies. The Contractor will also be expected to attend any internal NIAMS meetings related to the management and oversight of clinical trials to facilitate meeting setup and recording of meeting minutes. It is expected that the Contractor’s presence on site will help to create a rapport with NIAMS staff to help facilitate the activities under this contract.

41. Pg. 10. Attachment 3, Statement of Work. Task 9 CDE Advisory Panel - What is the government's expectation for the period of performance for this task? Are the requested Tasks only relevant in the Base year or does the NIAMS anticipate the level of effort to be consistent across base and all option years?

ANSWER: At this time it is not known when this task will be initiated. Please anticipate the level of effort to be consistent across the base and all option years.

42. Pg. 11. Attachment 3, Statement of Work. Task 10 states that recommendations and minutes should be provided to the NIAMS within 2 and 5 days respectively, is this assumed to be working days or calendar days?

ANSWER: Working days.

43. The RFP does not provide an estimated level of effort by task or an FTE assumption. Can the government provide any guidance or assumptions as it relates to overall cost or FTEs?

ANSWER: The offeror should propose based upon their approach to fulfilling the requirements of the Statement of Work.

44. For offeror reference, can the Government provide FTE projections and/or maximum funding levels for the base period and each of the 4 option periods?

ANSWER: The offeror should propose based upon their approach to fulfilling the requirements of the Statement of Work.

45. This section says that active studies will be monitored by a SO appointed by NAIMS.

Does this mean that the offeror will be expected to "recruit"/ present SO candidates to NAIMS, and NAIMS will choose the person for the position? Or is the offeror not involved in the selection process at all?

ANSWER: The Offeror will find suitable persons in a specific scientific area/field and propose the candidates for NIAMS consideration for selection of Safety Officer for a designated study.

The Offeror is expected to facilitate this process through communication with the proposed candidates. The selection of the SO will be made by the NIAMS.