Amendment_2_to_RFP_NIH-NICHD-2019-01.pdf

Amendment 2 to RFP NIH-NICHD-2019-01, “Medications Development Clinical Trials Network for the Treatment of Alcohol Use Disorder – Contract Research Organization”

AMENDMENT 2

Request for Proposal (RFP) NIH-NICHD-2019-01 entitled, “Medications Development Clinical Trials Network for the Treatment of Alcohol Use Disorder – Contract Research Organization”

Amendment Number: Two (2)

Amendment Issue Date: December 12, 2018

Proposal Intent Response Sheet Due Date: December 3, 2018

Proposal Due Date: December 17, 2018 (unchanged)

Issued By: Daniel Federline

DHHS, NIH, NICHD

Office of Acquisitions

NIAAA CMB

Point of Contact: Daniel Federline Contact Email: daniel.federline@nih.gov

THIS AMENDMENT IS ISSUED TO ALL POTENTIAL OFFERORS:

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of proposals has NOT been extended. Offerors must acknowledge receipt of this amendment by identifying this amendment number and date on each copy of the offer submitted. Failure to receive your acknowledgement may result in the rejection of your offer.

Except as provided herein, all terms and conditions of the RFP remain unchanged and in full force and effect.

PURPOSE OF AMENDMENT:

1. To provide answers to additional RFP Clarifications submitted on December 10, 2018.

Specifically, the answers are below:

General & Technical Questions

1. We noted the duration of CRO involvement is 7 years. Kindly confirm that the duration is inclusive starting from project award and terminating with final delivery of the Trial Master File. While there is statistical support of a publication, we would be able to manage the deliverable when the task arises

ANSWER: The ordering period for the IDIQ is seven (7) years.

mailto:hanacekp@mail.nih.gov

Amendment 2 to RFP NIH-NICHD-2019-01, “Medications Development Clinical Trials Network for the Treatment of Alcohol Use Disorder – Contract Research Organization”

2. In our proposed EDC platform, there are integrated subsystems can be used as electronic source data. This capability streamlines the flow of data from source data and the actual clinical data and, thus, efficiently maximizes the monitoring of data by Clinical Research Associates. In lieu of a final protocol, what electronic source data is the NIH expected to utilize?

ANSWER: Offerors can describe their proposed platforms in the technical proposal based on their understanding of the Statement of Work and criteria as outlined in the Solicitation. The Government intens to utilize the EDC for both source and CRFs. For budgeting purposes an Offeror can assume that there will be up to 20 assessments.

3. On the travel aspect of this bid as a CRO we will typically be abiding to our travel policy/rates will these be adjusted to the NIAAA standards?

ANSWER: Offerors are expected to include one copy of their (and any proposed subcontractor’s) written travel policy with the business proposal. If no such travel policy exists, the Offeror shall state so.

4. Do you require “cost realism” or is this bid exempt?

ANSWER: See Section M, COST/PRICE EVALUATION for details on what will be evaluated regarding cost realism.

5. In Attachment 3a, section 3, part J, a “CRO shall establish and oversee a Data and

Safety Monitoring Board (DSMB)”. The interim clinical data presented to the DSMB is usually part of a data lock which requires extensive data cleaning and monitoring. In lieu of a of a clinical protocol, how many interim locks and DSMB meetings are expected?

ANSWER: While it is up to DSMB to determine the frequency of their meetings, for costing purposes assume a summary report will be presented to DSMB quarterly.

General & Technical Questions