QA_NIAID_eQMS_eTMF_070319.pdf

Questions and Answers Electronic Quality Management System (eQMS) and Electronic Trial Master File (eTMF) for

National Institute of Allergy and Infectious Diseases (NIAID) Solicitation ID: RFQ-RML-75N93019Q00001

7/3/2019

1. General Questions

Q1a. Question about whether companies from Outside USA can apply for this?

A1a. Companies outside the USA may submit quotes if they have an active SAM registration. Reference Section V. Instructions in the solicitation.

Q1b. Whether we need to come over there for meetings?

A1b. Per SOW Section 5.2.1 there is an onsite meeting expectation.

Q1c. Can we perform the tasks (related to RFP) outside USA?

A1c. There are multiple onsite tasks such as meeting and training. Please reference SOW.

Q1d. Can we submit the proposals via email?

A1d. Yes. Reference Section V. Instructions in the solicitation.

Q1e. In terms of providing video narrative, is there a preferred way to provide this information with our proposal? (e.g., YouTube hyper link, Video file attachments, etc.)

A1e. NIAID does not have a preference for how the video is provided.

Q1f. Does the past performance need to be submitted as a separate volume or just a separate section within the technical volume?

A1f. NIAID requests past performance be submitted as a separate volume for evaluation purposes.

Q1g. To ensure file size of the technical document does not go over limits for emailing, will the contracting office allow screenshots to be submitted as a separate attachment?

A1g. Multiple attachments may be emailed as long as the volume number the attachment belongs to is clearly identified.

2. Questions related to Attachment 1 (Statement of Work)

Q2a. (Section 4.4.1 – Licenses, item #1, page 6) Item 1 of this section requests licenses to support internal and external access to support NIAID partners, CROs, and other collaborators. Can the Institute specify “other collaborators”?

A2a. NIAID’s collaborators include Universities, Biomedical Research organizations, Research Networks and Consortia, and non-governmental organizations (NGOs).

Q2b. (Section 4.4.1 – Licenses, item #1, page 6) Is it the Institute’s desire to provide access to the eTMF with Trial Sites (e.g. Sites would be able to upload their documents to the system through a portal)?

A2b. NIAID will eventually want to provide access to the eTMF to Clinical Sites around the world, although the Institute’s initial focus will be on maintaining a Sponsor Trial Master file.

Q2c. (Section 2.3 – Clinical Research Systems, item #5, page 8) Please clarify if CRIMSON is a home-grown system or a configured vendor system. If vendor system, which vendor?

A2c. CRIMSON is not a Commercial Off-the-shelf (COTS) system.

Q2d. (Section 4.2 – eTMF Requirements, item #4, page 12) The Institute states a centralized repository for eTMF and eQMS is a must. Please provide clarity on why this is a must.

A2d. The Institute desires the ability to easily move and link documents and other content between the eTMF and eQMS. NIAID expects the system to have a logically centralized repository for content.

Q2e. (Section 5.3 – Optional Tasks, page 21) The pricing sheet (Attachment 2) includes an area to submit pricing for integration and data migration, including columns to estimate quantity of project hours and price. Does the Institute have an expectation to receive complete pricing information on migration and integration at this stage?

If yes, the vendor(s) will require much more detailed discussions.

A2e. No, the Institute does not expect to receive complete pricing for migration and integration. NIAID expects these tasks to be conducted on a Time and Materials basis and expects quoters to specify labor category rates and estimated hours. For quoting purposes assume a range of 400 – 500 hours per Optional Task (Integration and Data Migration).

Q2f. (Section 4.1.2, page 10) We are currently exploring 508 compliance. However, at this time our solution is not currently 508 compliant. Do solutions have to be 508 compliant upon contract award or can this be accomplished during the course of the contract?

A2f. Solutions must be 508 compliant upon contract award or have a detailed plan and timeline on how 508 issues are going to be remediated before go-live.

Q2g. (Section 4.1.2 – General, item #12, page 9) Under what conditions would a vendor be considered without Section 508 compliance?

A2g. See A2f.

Q2h. (Section 4.1.1 page 9)

Within our licensing structure, users are defined as Power (Admin) and Consumer (non-admin).

Considering this, how many total power and consumer user licenses will NIAID need? Will NIAID need these to be named, or concurrent licenses?

A2h. NIAID expects 90-95% of users to be “Consumers” and 5-10% to be “Power (Admin)”. NIAID expects named user licensing, but will consider a concurrent licensing scheme if it is advantageous to the Government.

Q2i. (Section 4.1.2, #3, page 9 The statement of work says: “Be accessible from within and external to the NIAID network by employees and partners for a variety of tasks and user types”. Please provide examples of external partners and the estimated number of external users.

A2i. See A2a. Initial users will all be internal, however, Solutions should be able to provide access to users who successfully authenticate through the NIH Single-Sign-On system.

Q2j. (Section 4.1.5, #1, page 11) The statement of work says: “Automatic versioning”. Please define versioning and whether revisions are acceptable.

A2j. NIAID defines versioning as automatically creating a copy of the document each time it is edited or a new version is uploaded to the system with a time and date stamp as well as information on the user who made the change. NIAID defines a Revision as a formal version of a document, for example, the approved, accepted version of a Standard Operating Procedure.

Q2k. (Section 4.1.5, #5, page 11) The statement of work says: “Shared access between eTMF and eQMS”. Are user links to these separate databases acceptable?

A2k. Shared links between the two systems are acceptable, however, NIAID is expecting an integrated solution where content from the eTMF and eQMS can be easily exchanged and cross-referenced.

Q2l. (Section 5.4, pg. 22) FBO page (instructions to offerors) In Section 5.4 of the SOW, it states: “Skilled experienced professional and/or technical personnel are essential for accomplishing the work to be performed. These individuals are defined as “Key Personnel” and are those persons whose resumes were submitted and marked by the Contractor as “Key Personnel”. Within the Instructions to the Offeror on the FBO page, it states, “Resumes are required for all proposed staff. Resumes should be limited to three pages and must include the proposed labor category for the individual.” Should responders assume that all project personnel are key?

A2l. No, NIAID anticipates only the Project Lead is key.

3. Questions related to Attachment 2 (Pricing Sheet)

Q3a. What is the projected number of studies and sites the Institute anticipates running in Year 1, Year 2? Alternatively, can the Institute provide an estimate of average number of studies and sites typically run in a year?

A3a. NIAID is conducting approximately 500 clinical trials across 400 sites world-wide. Assume a 5-10% annual increase. Please note that NIAID expects per-user pricing regardless of the number of studies or sites but will consider alternatives if they are advantageous to the Government.