MOD_3.Responses_to_Questions.pdf

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Previous edition unusable

Nora I. Rivera

This modification to solicitation no. HHSNIHOLAO263(NINR)2017-NR serves to extend the proposal submission date to Thursday, March 16; 9 a.m. Eastern Standard Time. The Government is providing responses to questions from offerors as part of this modification and attachments 1 and 3 of the RFP.

National Institutes of Health

OD/OM/OALM/OLAO/OA

6011 Executive Boulevard, Suite 529 Rockville, MD 20892

HHSNIHOLAO263(NINR)2017-NR

1 16

02/24/2017

02/24/2017

Nora I. Rivera -S Digitally signed by Nora I. Rivera -S DN: c=US, o=U.S. Government, ou=HHS, ou=NIH, ou=People, cn=Nora I. Rivera -S, 0.9.2342.19200300.100.1.1=0011060254 Date: 2017.02.24 20:40:56 -05'00'

RFP No. HHSNIHOLAO263(NINR)2017-NR National Institute of Nursing Research (NINR) Resourcing Center

TECHNICAL QUESTIONS

1. Within the 20 on-site simultaneous studies needing protocol support, can the government breakdown the number of clinical trials and the number of studies (i.e., natural history and evaluation/treatment studies)? We are planning for up to 20 studies.

Response: (1) Currently have 10 active protocols: 6 are Natural History studies, 3 are Clinical Trials, and 1 is a Screening protocol. One of the Clinical Trials has an IND (Investigational New Drug application) with the FDA. (2) There will be at least 2, and possibly 3, new protocols that will be submitted to the IRB for approval in the next year.

2. What is the typical size of the clinical trials?

Response: The typical size of a clinical trial has been ranging from 56 to 100 subjects.

3. What is the typical size of the studies?

Response: The accrual ceilings range from 90 to 100.

4. What number of clinical trials are single center trials?

Response: All 3 clinical trials are single-center

5. What number of clinical trials are multi-center trials and what is the number of sites?

Response: There are no multi-center clinical trials.

6. What number of studies are single center studies?

Response: There are five (5) Natural History studies and one (1) screening protocol are single-center

7. What number of studies are multi-center studies and what is the number of sites?

Response: One (1) Natural history study is multisite (one site additional to NIH); but this study may close within the next year.

8. For the multi-center sites clinical trials and/or studies, is there an established set of centers, or a “cooperative group” or do they work within established multi-center institutes of cooperative group frameworks.

Response: There are no established centers, no cooperative groups, no established multi-center institutes

9. Conducting a search on NINR’s public domain and clinicaltrials.gov., we found approximately a dozen intramural studies in the recruitment phase or soon to be in the recruitment phase. Are these to be consider within the 20 on-site simultaneous studies needing protocol support?

Response: We plan for up to 20 studies. There are currently 10 active protocols, an additional 5 are in data analysis only, and there will be 2-3 new studies submitted to the IRB during the next year.

10. Task 1: Protocol Navigation Can NINR provide estimates for the following activities?

a. Number of total protocols that will be written per contract year?

Response: Approximately 10-12 active protocols that will need assistance with writing of amendments and continuing reviews and 1-2 new protocols per year; with a possibility for a third. For proposal purposes, the Government recommends that offerors base their responses on an estimated 3 new protocols per year.

b. Given the varying complexity of clinical research, can NINR provide an estimated breakdown of the type of research studies (i.e., observational, behavioral, interventional studies - Phase 1, Phase 2, and Phase 3?) that would require support per contract year?

Response: Currently, there are 10 active protocols: 6 are Natural History studies, 3 are Clinical Trials, and 1 is a Screening protocol. One of the Clinical Trials has an IND (Investigational New Drug application) with the FDA. The Government estimates that there will be at least 2, and possibly 3, new protocols that will be submitted to the IRB for approval in the next year (2 Natural History and 1 Clinical Trial).

http://www.clinicaltrials.gov/

c. Number of regulatory submissions per contract year to support preparation of “regulatory documentation for submission to the Food and Drug Administration (FDA) and other regulatory agencies”?

Response: This can vary with the number of adverse events that occur. The Government estimates 5-10 submissions per year.

d. Number of trainings per contract year to support, “training to NINR DIR staff about the process of protocol navigation”?

Response: This may or may not occur each year. For proposal purposes, estimate 2 per year.

e. Number of meetings per contract year to support, “logistical support for study meetings”?

Response: This may or may not occur each year. For proposal purposes, estimate 2 meetings per year.

11. Task 2: Development of Manuals of Procedure, Study Forms, and Procedures

Can NINR provide estimated number of studies where the NINR Resource Center would be required to:

a. Participate with study investigators to develop and revise selected study manuals, forms and procedures?

Response: For proposal purposes, estimate 3 new studies.

b. Assist study investigators to develop an on-site subject recruitment plan?

Response: Possibly 1-3 new studies. For proposal purposes, estimate 3 new studies.

c. Assist study investigators to develop publicity materials to improve patient recruitment?

Response: For proposal purposes, estimate 3 new studies and 1 continuing study.

12. Task 3. Study Monitoring and Communications

a. Does NINR anticipate monitoring will be performed through on-site visits conducted by a Clinical Research Associate (CRA)?

Response: Yes, a CRA or other similarly qualified personnel. At this time, we will have the contractor monitor only IND-FDA clinical trials (1-3 studies).

b. Will monitoring occur at the NIH Clinical Center, or will there be external study sites? If so, where are the sites located?

Response: Monitoring will occur on-site at the NIH Clinical Center.

c. The Resource Center shall be responsible for monitoring “selected NINR studies” for problems and deviations - does NINR intend the monitoring visit frequency to be data driven, or would studies be selected “for cause” (i.e. after NINR has identified problems/deviations)?

Response: Monitoring is risk-based and will initially focus only on IND-FDA clinical trials.

d. In its monitoring role, will NINR Resource Center staff have access to study databases?

Response: Yes, NINR Resource Center staff will have access to study databases.

13. Task 4: Data Analysis

a. What are the data sources for the NINR Resource Center analyses – the investigators’ clinical study databases?

Response: Yes and the NINR-wide Clinical Trials Data Base (CTDB) system.

b. Please provide details of the data sources/databases technology (e.g., number of data bases, type of database, size of database(s), file formats, etc.). Investigators may use excel spreadsheets as well as the Clinical Trial Data Base (CTDB).

Response: CTDB is a web-based application that supports flexible data capture, and reporting. The system is hosted at the NIH in Bethesda, MD. It is accessible via the Internet through the NIH firewall, on both Mac and Windows based computers. An Oracle relational database is utilized to capture and secure data entered through the web interface.

c. On item b., the SOW states, “In collaboration with the NINR OCD or Monitoring Committees, review the database for possible analyses to aid in monitoring or improving the quality of the data including data capture, analysis and reports.” Can the government provide a detailed description of the referenced database?

Response: See 13b.

d. What is the anticipated number of meetings per contract year for Data Safety Monitoring (DSMB) Committees and Independent Monitoring Committees?

Response: Four (4) times yearly for the current Independent Monitoring Committee (IMC). Future DSMBs may require 2-3 meetings per year, but we do not currently have an independent DSMB. For proposal purposes, estimate 4 IMCs and 4 DSMBs.

14. The Technical Evaluation Factors of the RFP (Factor 1), contain the following statements as suggested solutions, “Processing the ICSRs and maintaining the database including but not limited to, data entry, image processing and redacting of personal information using a Captiva Input/Accel imaging system, filing of ISCRs. Insuring the safe and orderly operation of the CAERS work area including equipment use and maintenance of government property; procedures to ensure the security of CAERS data and the facility that houses CAERS equipment and files, both electronic and physical.” References to ICSRs and CAERS are not explicitly cited in the SOW. Can the government please provide more details for these reference?

Response: NINR doesn’t work with CAERS. The Government will remove this language from the Technical Evaluation Factors of the RFP.

15. Is the government inferring that the contractor must develop and maintain an ICSR database?

Response: No, NINR does not use ICSR database.

16. Is the government requiring the database and system interface with Captiva Input/Accel imaging system?

Response: No, NINR does not use this system and the language will be removed.

17. Can the government please provide details of the “CAERS work area”?

18. Is this a current and up and running environment at NINR?

19. If yes, is the environment supported by an industry contractor?

20. Can you provide the name of that contractor?

Response: For questions 17 to 20, see response to question 14.

21. Who will be the sponsor of record for each trial or study?

22. Please confirm either NINR or another party (eg. sponsor of record) will hold all site contracts.

23. Please confirm either NINR or another party (eg. sponsor of record) will hold all DSMB contracts

Response: For questions 21-23 – NINR

24. The following Technical Evaluation Factors for Award on p.33 of the RFP are not reflected in the Required Expertise sections in the Statement of Work.

a. “Processing the Individual Case Reports (ICSRs) and maintaining the database including but not limited to, data entry, image processing and redacting of personal information using a Captiva Input/Accel imaging system, filing of ICSRs.”

b. “Insuring the safe and orderly operation of the Center for Food Safety & Applied Nutrition (CFSAM) Adverse Event Reporting System (CAERS) work area including equipment use and maintenance of government property; procedures to ensure the security of CAERS data and the facility that houses CAERS equipment and files, both electronic and physical.”

Please clarify whether the successful offeror must have specific expertise in these areas to fulfill the requirements of the SOW.

Response: N/A. We do not use these areas. The language will be removed.

25. Is the contractor expected to maintain government property, as stated in the Evaluation Criteria for Technical Approach? If so, please provide a list of Government Furnished Equipment.

Response: No

26. Has a Data and Safety Monitoring Committee been established, or will the Contractor be responsible for assisting NINR in compiling the group?

Response: Current studies do not have an NINR Data Safety Monitoring Committee (NINR uses a collaborative resource for this). This may be needed in the future for NINR.

27. The RFP states there may be up to 20 protocols. Are these 20 protocols new studies or will some be protocols that are currently ongoing? If there are studies currently underway, could you provide a breakdown of these studies by type/size/Health Authority oversight? Of the 20 protocols noted in this RFP, are there any that will be multi-center? Are any studies anticipated to include “healthy volunteers?”

Response: 1) There are currently 10 active protocols: 6 are Natural History studies, 3 are Clinical Trials, and 1 is a Screening protocol. One of the Clinical Trials has an IND (Investigational New Drug application) with the FDA. (2) One Natural History study is multisite (but may be closing in the next year). (3) Five additional protocols are in Data Analysis only stage (one of these studies has an IND). (4) There will be at least 2, and possibly 3, new protocols that will be submitted to the IRB for approval in the next year. (5) One of the Clinical Trials has a study arm for Healthy Volunteers.

28. If there are studies currently underway, please provide the details of the databases used to collect data for these studies. Would vendors be expected to propose data management systems for new studies? Please elaborate on-site/off-site requirements for personnel performing work under this contract.

Response: Offerors will not need to propose a data management system. We use the Clinical Trial Data Base (CTDB) system. CTDB is a web-based application that supports flexible data capture, and reporting. The system is hosted at the NIH in Bethesda, MD. It is accessible via the Internet through the NIH firewall, on both Mac and Windows based computers. An Oracle relational database is utilized to capture and secure data entered through the web interface.

Vendor will occasionally need to come to campus to meet with staff but much of the work can be performed electronically/remotely.

29. Under Task 2, it states that RC will participate in ‘design, development, and revision of detailed manuals of procedures and data forms…’- please clarify if the development of the forms includes data management and query reporting for NINR OCD approved studies.

Response: Form development may include assistance with developing CRFs (case report forms).

Form development will not include data management and query reporting.

30. Please provide the deliverable date for each deliverable for tasks 1 to 7?

Response: The Government has determined that Tasks 1-7 are already part of recurring activities under the statement of work and will be removed from under the Deliverable section of the RFP.

31. Please clarify the anticipated needs for site subject recruitment assistance (task 2, parts b and c).

For example, are expectations solely for the prospective vendor to share marketing, advertising, and strategic planning templates for which site teams will then assume responsibility for adapting and executing, or is a more collaborative partnership anticipated?

Response: A collaborative approach may include contractor support for contributing to sponsor and site level strategies, developing advertising and marketing materials, executing and evaluating recruitment initiatives, and recalibrating approaches as needed throughout the study lifecycle. Expectation would be for vendor to share marketing, advertising and strategic planning templates for which site teams will then assume responsibility for adapting and executing.

32. SOW Protocol Support (pg. 5) The solicitation expects approximately twenty (20) studies may be conducted simultaneously. Can the Government provide the approximate number of studies by study type (interventional vs. non-interventional) and disease area? Among the interventional clinical trials, can you provide the approximate number by phase (I-IV)?

Response: There may be up to 20. Currently we have 10 active studies: 6 are Natural History studies, 3 are Clinical Trials, and 1 is a Screening protocol. One of the Clinical Trials has an IND (Investigational New Drug application) with the FDA, which is Phase III. There will be at least 2, and possibly 3, new protocols that will be submitted to the IRB for approval in the next year (2 Natural History and 1 Clinical Trial). NINR focuses on symptom science. Areas include cancer-related fatigue, neuromuscular disorders, traumatic brain injury, and digestive disorders.

33. SOW Task 1, Item G (pg. 2) Task 1, item g states that “the Contractor shall provide logistical support for study meetings when necessary.” Is there an estimated number of meetings that will take place within the contract year? Will the Contractor be responsible for providing reimbursement for travel for meeting participants?

Response: For proposal purposes, the Government estimates 2 meetings per year in Bethesda, MD. Assume that costs will be charged to the contract.

34. SOW Task 2 (pg. 2). Is the NINR CDE working group working on more CDEs and standard forms, in addition to the CDEs registered in the NIH CDE repository?

Response: CDEs are not part of this requirement and will be removed from the SOW.

35. SOW Task 4, Item B (pg. 3) Task 4, item b states that “the Contractor will review the database.”

Will there be one central database for all studies? Will the Contractor have remote access to this system?

Response: We have one database. We use the Clinical Trial Data Base (CTDB) system. CTDB is a web-based application that supports flexible data capture, and reporting. The system is hosted at the NIH in Bethesda, MD. It is accessible via the Internet through the NIH firewall, on both Mac and Windows based computers. An Oracle relational database is utilized to capture and secure data entered through the web interface.

36. The SOW appears to include the need for travel by contractor personnel (e.g., the initial kick-off meeting) and the Business Proposal instructions request a copy of the offeror’s travel policy.

Please indicate how travel costs will be handled in the resultant contract and if any travel estimates are requested at this time.

Response: See response to item 33.

37. Page 5 of 7 of the Statement of Work indicates that “approximately 20 studies may be conducted simultaneously, including Clinical Trials as well as Natural History and Evaluation/Treatment studies.” Does this mean that the offeror should assume that 20 simultaneous studies will require support at contract start? Is this assumed to be a good faith projection of the steady state of work throughout the project period?

Response: There may be up to 20 studies over time. Right now we have 10 active studies with 2-3 additional studies projected to start in the next year.

38. Regarding the 20 studies mentioned above, please provide, if possible, any further details, such as the following:

a. Number of each type of study (e.g.: 5 clinical trials, 4 natural history studies, etc.)

Response: Currently, we have 10 active studies: 6 are Natural History studies, 3 are Clinical Trials, and 1 is a Screening protocol. One of the Clinical Trials has an IND (Investigational New Drug application) with the FDA.

b. Average # of sites utilized by each study:

Response: Only one study has an additional site and this study may close within the year. Average patient sample size 90-500 accrual ceilings.

c. For clinical trials, please indicate:

i. study phase (I-IV)

Response: Study Phase is III

ii. percentage conducted under an IND and/or CRADA

Response: one-third

iii. If randomization is required?

Response: Yes, and this is done by our pharmacy

iv. Regularity of travel for site visits (i.e. # of annual interim monitoring visits):

Response: Twice yearly for IND study monitoring, and as needed for meetings

39. Will the offeror be asked to provide a system for electronic data capture?

Response: Not at this time

40. Will the offeror have access to data in real time or only through periodic data transfers?

Response: Real time, if needed.

41. Will the offeror be responsible for FDA submissions or only for supporting investigators through this process?

Response: Setting up a file system and assisting with submissions

42. Will the offeror be responsible for managing SAE/AE processing and reporting?

Response: Our IRB system has a system for processing and reporting but investigators will need assistance with tracking and documentation in their files.

43. Does the protocol navigation task require the contractor to manage and site essential documents?

Response: The navigator will coordinate and manage protocol communications and documents.

44. Will the offeror hold the trial master file or assist investigators and study teams with this responsibility?

Response: The offeror will assist investigators/teams.

45. General. Does NINR have established policies/procedures for data transfer, archiving, de-identification and sharing?

Response: YES

46. Does the Contractor need to provide secured data transfer and storage capability, or NINR has established system? Please confirm the Contractor need to support statistical programming (i.e., SAS programming) in addition to the statistical analyses to the study investigators.

Response: Contractor will not need to provide the programming.

47. Does the government anticipate that contractor support would be provided on-site a2 NINR?

Response: Contractor would occasionally come to NIH, but will also work remotely.

48. Is Captiva Input/Accel imaging system implemented and currently in use at NINR?

Response: Not applicable to this requirement. Language will be removed.

49. Where is “the facility that houses CAERS equipment and files, both electronic and Physical” located?

Response: Not applicable to this requirement.

50. Section M – Evaluation Factors for Award (pgs. 33-34) list 2 technical evaluation criteria. The items appear to possibly to have been taken from an unrelated solicitation as they do not correlate with the Statement of Work. Please provide the correct evaluation factors.

Technical Evaluation Criteria The evaluation factors are used by the technical evaluation committee when reviewing the technical proposals. The factors below are listed in the order of relative importance.

Technical Approach - Quality of Design 45 points

Originality, merit, and feasibility of the proposed method of accomplishing the objectives of the Statement of Work, including discussion of the problems, issues, and scientific efforts associated with the procedures for example, processing the Individual Case Reports (ICSRs).

Personnel Qualifications 35 points The proposal should demonstrate the contractor’s personnel experience in providing services to others similar to those outlined in the statement of work. In particular, experience processing ICSRs for the FDA should be detailed. The proposal should demonstrate the contractor’s administrative, management, and technical support for activities related to the statement of work as demonstrated by the availability of corporate resources such as technical expertise in processing scientific documents, scientific indexing, data entry, data base maintenance, and development, testing experience in imaging and database management procedures, and initiatives to encourage retention and minimize turnover of qualified personnel.

Quality Control Procedures 20 points Methods to protect the integrity of the projects including: plans to protect the confidentiality of data; plans to assure data integrity; and plans to monitor compliance to protocol.

BUSINESS QUESTIONS

1. Can the government please provide suggestions for the type of staff desired (i.e., labor categories and descriptions)?

Response: Each offeror shall propose a strategy to fulfilling the Statement of Work, personnel, and the associated/proposed estimated costs. The Government recommends using the following yearly assumptions as a reference. Please include hourly rates, percent of “Fringe Benefits”:

2. Can the government please provide estimates for the level of effort (in hours) for Tasks 1 through 7?

3. Will you provide a level of effort (LOE) by labor category to inform and standardize the budget estimate? Are there any uniform pricing assumptions for Other Direct Costs on which we could base our budget estimate?

4. What is the government’s estimate of the effort required?

5. The contract type calls for Time and Materials with little detail on the number of staff, the description of the type of staff desired (i.e., labor categories and descriptions), and the level of activity for Tasks 1 thorough 7. Typically, details and/or estimates are provided in some or all of these areas in order for the government to receive industry responses that don’t vary widely from the scope of work and are consistently evaluated fairly. Can the government please provide estimates for the number of staff?

6. Can the government please provide suggestions for the type of staff desired (i.e., labor categories and descriptions)?

7. Can the government please provide estimates for the level of effort (in hours) for Tasks 1 through 7?

8. In accordance with the Time and Materials contract-type, we request that the Institute specify requested labor categories with designations of key personnel.

9. Given the rapid start-up of the project in early April of 2017, we ask that you provide a good-faith estimate of the level of effort that will be required from the contractor upon contract award, and, to the extent possible, in the first 6-12 months.

Response: Questions 1-9, see response to question 1.

Direct Labor % Effort Statistician 1 10% Computer Support 1 25% Protocol Specialist 2 100% Data Coordinator 1 25% Data Management 1 25% Clinical Trial Coordinators (on site) 2 or 1? 1 100% Administrative Support 1 5%

10. Should we provide T&M rates for contractor site and government site work?

Response: Yes.

11. Are the resumes included in the page count of 50 for the technical proposal?

Response: No.

12. Will final contract award include FAR 52.228-7?

Response: A cost-reimbursement contract is not contemplated.

13. As the SOW is further clarified, we believe that some Other Direct Costs may be required to enable contractor performance. Please indicate how such costs will be handled in the resultant contract and if any estimates are requested at this time.

Response: Offerors shall propose a strategy for fulfilling the statement of work and estimated costs. Offeror can proposed ODCs, if needed. The offeror shall submit a detailed budget; see attachment 9.

14. There are some discrepancies in reference to solicitation attachments and some gaps in what is actually provided. Only the SOW is provided, and it is designated as Attachment #1. Please provide all of the Solicitation Attachments noted in Section J with priority to the Packaging and Delivery of Proposal.

Response: The Government provided the links to attachments except 1, 2, 3. Attachments 1 and 3 are added.

15. The instructions in Section L (pg 24) state that there should be 3 volumes: Technical, Past

Performance, and Price. There are no instructions for the Past Performance volume. The only reference to Past Performance information is on pg. 26 and refers to what should be submitted as part of the Technical Proposal response. Further, the language use typically refers to the Business Proposal. Please clarify where Past Performance information should be included and exactly what content is requested.

Response: Past Performance is a “volume” that shall be included with the Technical proposal.

16. Section L, page 24, puts a page limit of 50 pages on the technical volume. Please confirm that cover pages, tables of contents, any other required front matter, CVs, literature cited, and any reasonable appendix documents shall be exempt from this limit.

Response: See response to question 21.

17. Article G.2 RFP, Key Personnel, lists no roles or resources listed as key. Please confirm that no role is considered contractually key for this contract. If one or more roles are considered key, please validate whether a Summary of Related Activities form is expected as part of the proposal?

Response: Key Personnel is proposed by the offeror; see response to question 1. Summary of Related activities is expected.

18. Section L, 1.a., (Page 24) states that the proposal shall be in 3 volumes: Technical, Past Performance, and Price. Page 26 of Section L, 1. Past Performance Information, indicates the Past Performance information should be included within the Technical Volume. Please clarify.

Response: Past Performance is a volume. However, the Government is requesting that it be included with the Technical Volume.

19. Section L, 1.a., (Page 24) states that the proposal shall be in 3 volumes: Technical, Past Performance, and Price, and that price should not be included in the first two volumes. Section J lists the Technical Proposal Cost Summary under the Technical Proposal. Please confirm that the Technical Proposal Cost Summary is not to be included in the Technical Proposal.

Response: This statement is correct. Offerors shall not to include the detailed budget Excel Workbook, attachment 9, with the Technical Volume. However, please include the one page Technical Proposal Cost Summary, attachment 5, under the Technical Proposal.

20. Section J lists the Contractor non-disclosure agreement as an Attachment for the Technical Proposal. Please clarify whether this is an RFP requirement or a deliverable after award.

Response: The non-disclosure agreement is a post award deliverable.

21. Section L, 1.a., Format, on page 25 states that the page limit for responses is 50 pages. We respectfully request that the following be excluded from the page count:

a. Cover letter

b. Title page

c. Table of Contents

d. Section 508 Compliance form

e. Summary of Related Activities (if required)

f. Government notice for handling proposals (if required)

g. Technical Proposal Cost Summary (if required)

h. Information Security section (if required)

i. Resumes/CVs (if required)

Response: Items a. through i. are excluded from the page count.

Mod 4.Business Questions