Attachment 9 - Solicitation Questions and Responses.pdf

Solicitation No. NIMH-22-003252 Amendment 01 - Solicitation Questions and Government Responses

Title: Clinical Research and Study Monitoring Support for NIMH Studies

No. Reference (if any)

Question Government Response

1 For budgetary estimating purposes can NIMH provide guidance on the anticipated number of monitoring trips that are expected to be completed by the offeror on an annual basis, and the clinical site locations?

The National Institute of Mental Health (NIMH) expects up to four clinical site monitoring visits at four different clinical sites within the period of performance year. The clinical site locations (within the US and Canada) will be determined as needed by the NIMH.

Combined Synopsis and Solicitation

Please confirm that Offerors are to provide one comprehensive proposal that includes Offeror’s Technical Approach, Management Approach, Past Performance and Price for this response.

Please refer to the amended Combined Synopsis and Solicitation provided with amendment 01 for details.

3 Combined Synopsis and Solicitation

While some information was provided in the Combined Synopsis and Solicitation, please clarify what the specific Instructions to Offerors are for proposal submission, specifically regarding margins, font size for text and tables/graphics, and page limits.

Please refer to the amended Combined Synopsis and Solicitation provided with amendment 01 for details.

4 Attachment 6- Additional Terms and Conditions

Attachment 6, Information Security and/or Physical Access Security, Section A.2.b (p.4) states “if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party.”

Please confirm if the Government is willing to modify the one (1) hour requirement to a 24-hour requirement.

o See also D.3 and D.5 (p.9) which also includes a requirement for reporting of all suspected and confirmed information security and privacy incidents and breaches within one (1) hour or less.

o See also “Incident Response” within List of Deliverables (Att. 6, p.13), stating an incident report is due “NIH/NIMH policy states as soon as possible or no later than 1 hour of discovery.”

The Government is willing to modify the one (1) hour requirement to report if existing safeguards have ceased to function to a 24-hour requirement.

5 Attachment 1

SOW

Please provide the required labor hours/FTE assumptions for personnel (e.g., site monitors) other than the Supervisory Program Manager (250 hours per year).

NIMH expects up to four clinical site monitoring visits at four different clinical sites within the period of performance year. The expectation is that three site monitors will complete a clinical site monitoring visit in a ten-business day period (eighty hours per monitor). Please refer to Attachment 10 – Price Schedule Template

6 Attachment 1

SOW

For budgeting purposes, please provide the number of anticipated visits per year, duration of the visits, and number of visit attendees that Offerors should assume in each year of the 5-year period of performance.

performance year. The expectation is that three site monitors will complete a clinical site monitoring visit in a ten-business day period (eighty hours per monitor). Please refer to Attachment 10 – Price Schedule Template

7 Attachment 1

SOW

What is the anticipated start date of the award/period of performance?

The anticipated start date of the award/period of performance is August/September 2022.

8 Attachment 1

SOW

Please confirm if the Government will accept a T&M or Unitized budget for this opportunity.

This requirement will be a Time & Materials Contract.

Please refer to Attachment 10 – Price Schedule Template

9 How many clinical monitoring visits per month are expected to be performed by the contractor for this effort?

four different sites within the period of performance year.

10 What percentage of clinical monitoring visits would be expected to take place at the NIH clinical center?

The expectation is that clinical site monitoring visits will take place at sites that receive extramural funding from the NIMH. No site monitoring will take place at the NIH clinical center.

11 Does NIMH have an anticipated typical length of site monitoring visits i.e. # of days on site/monitoring visit?

NIMH is anticipating the typical length of a site monitoring visit to be ten business days.

12 SOW The SOW states that the government expects up to three travelers per trip. Are these all the contractor’s personnel, or does this include NIMH personnel accompanying the contractor’s monitors on study site visits?

The three travelers specified in the Statement of Work (SOW) would be contractor personnel. Due to the nature of the visits, NIMH personnel may accompany the contractor’s monitors on site visits to ascertain details that the monitors would not be contracted to do, e.g., talk to institutional financial staff about the study/grant being monitored.

13 How many individual clinical monitors does the NIMH anticipate that this effort would require?

NIMH expects up to three clinical monitors will be needed for a given clinical site monitoring visit.

14 Approximately, how many studies are expected to be supported by this monitoring program, per year?

NIMH expects clinical site monitoring visits for a very few select NIMH funded studies. NIMH expects up to four clinical site monitoring visits at four different sites within the period of performance year.

15 Is it correct that the Government will issue a time and materials contract for this RFQ?

Contractors will submit hourly rates for labor categories.

This requirement will be a Time & Materials Contract.

Please refer to Attachment 10 – Price Schedule Template

16 Are monitors experienced with 5+ years in monitoring clinical research trials (mainly oncology), but without specific psychiatry /mental health experience, acceptable to the project?

Please refer to the SOW, the training requirements are stated in the SOW under Section A. Clinical Site Monitoring Personnel on page 2.

17 SOW, General Requirements,

pg. 1

There seems to be no list of sites attached.

Please advise how many sites to be monitored?

18 Specialized Clinical Site Monitoring Visits

- A. Clinical Site Monitoring Personnel

In order to ensure we are meeting government expectations in presenting our team/resources, how many site monitors constitutes a ‘cadre of site monitors’?

Offeror should determine an appropriate number of site monitors to perform the work outlined in the statement of work.

19 Clinical Site Monitoring Personnel

Please clarify if this means that local (Canadian) monitors will be engaged, or international travel is expected? There are some differences in the US and Canadian regs for human studies, the monitors shall be familiar with both.

Contractor personnel should be able to complete visits in the United States and in Canada.

20 Specialized Clinical Site Monitoring Visits

Please advise how many monitoring visits are expected/estimated per the site?

21 LEVEL OF EFFORT Please advise that the PM effort shall be determined by the number of sites/visits and the number of monitors.

The PM’s effort shall be determined by the number of hours per clinical site visits.

22 DELIVERY OR

DELIVERABLES,

pg 5

This implies that some visits can be performed remotely. The remote visits are planned, organized, and performed differently than onsite; for this reason, please advise what portion of visits is expected to be remote?

Please refer to the revised SOW, section “Delivery or Deliverables, page 5

23 DELIVERY OR

DELIVERABLES,

pg 5

How many Clinical Site Monitoring visits are anticipated per period of performance?

24 Ad-Hoc Meetings and Reports, pg

Please advise how many teleconferences/meetings can be expected?

Shall the cap, (no more than XX meetings) be included in the proposal?

Please refer to the revised SOW, section “Ad-Hoc Meetings and Report, page 6

25 Level of Effort Can NIMH please provide an estimate for the anticipated level of effort for Clinical Site Monitoring per period of performance?

performance year. The expectation is that three site monitors will complete a clinical site monitoring visit in a ten-business day period (eighty hours per monitor). Please refer to Attachment 10 – Price Schedule Template

26 Level of Effort What other labor categories should offerors include to meet the contract requirements (e.g., site monitors, etc.)?

Please refer to attachment 10 – Price Schedule Template

27 Other Consideration:

TRAVEL

What assumptions should offerors use to estimate travel costs for Specialized Clinical Site Monitoring visits?

NIMH expects up to four clinical site monitoring visits at four different clinical sites within the period of performance year. The expectation is that three site monitors will complete a clinical site monitoring visit in a ten-business day period (eighty hours per monitor). Please refer to Attachment 10 – Price Schedule Template

28 General Who is the incumbent supporting these NIMH activities? This is a new requirement

29 Response Due Date

Please allow an extension of 2 weeks to allow offerors to properly and sufficiently respond to government answers.

Please refer to the amended Combined Synopsis and Solicitation provided with amendment 01 for the new proposal date.

30 Who is the incumbent for this contract?

This is a new requirement

31 What is the estimated number of active NIMH protocols/studies?

NIMH expects clinical site monitoring visits for a very few select NIMH funded studies. NIMH expects four clinical site monitoring visits at four different sites within the period of performance year.

32 Does NIMH have its own Clinical Trial Management System (CTMS)?

NIMH extramural doesn’t have a Clinical Trial Management System (CTMS).

33 Can NIMH provide the offerors an estimated # of labor hours for CRAs/Monitors per year to use for the pricing proposal performance year. The expectation is that three site monitors will complete a clinical site monitoring visit in a ten-business day period (eighty hours per monitor). Please refer to Attachment 10 – Price Schedule Template

34 How many CRAs does NIMH anticipate will be required per year. This information will be helpful for the pricing proposal.

performance year. The expectation is that three site monitors will complete a clinical site monitoring visit in a ten-business day period (eighty hours per monitor). Please

35 Is there a page limit for the Technical Proposal?

Solicitation provided with amendment 01 for details.

36 SOW page 2-4 Section II Specialized Clinical Site Monitoring Visits for both A. Clinical Site Monitoring Personnel and B. Specialized Clinical Site Monitoring Visits o What is the level of effort for the Monitors? Do you have an estimate of the number of site visits and frequency?

o As this can vary greatly depending on the frequency how would you like us to price this portion?

performance year. The expectation is that three site monitors will complete a clinical site monitoring visit in a ten-business day period (eighty hours per monitor). Please

37 Page 5 of the SOW states the level of effort is “Supervisory Program Manager 250 hours per period of performance”. Is this just the minimum level of effort? Based on the site visit requirements it appears the level of effort would greatly exceed this, not only for the supervisory PM based on the number of visits ordered but also a level of effort for clinical monitors.

How would site visits be ordered? Would a price submission be submitted at the time a site visit need is identified?

performance year. The expectation is that three site monitors will complete a clinical site monitoring visit in a ten-business day period (eighty hours per monitor). Please refer to Attachment 10 – Price Schedule Template

The Supervisory Program Manager will manage clinical site monitoring activities carried out by the site monitors.

Given the # of site visits and the role of the PM, 250 hours is estimated for each period of performance year.

38 Page 7 of the SOW indicates the government will authorize travel expenses. How would you like the offerors to incorporate travel costs into our price submission?

Please refer to attachment 10 – Price Schedule Template

39 Will the contractor provided laptops and telecom devices need to access government systems that require specialized IT security protocols.

Per the SOW there will be no government furnished property. The Government anticipates sending data or information to the contractor electronically.

40 Will the contractor provided laptops require specific software to access the NIH-controlled information system that is mentioned in the

SOW?

Per the SOW there will be no government furnished property. The Government anticipates sending data or information to the contractor electronically.

41 Will this be an FFP LH contract?

This requirement will be a Time & Materials Contract.

42 Do you have a max page requirement for the submission?

o If yes, does that number include resumes, reps & Certs, etc.?

Solicitation provided with amendment 01 for details.