1725057_JOFOC.pdf

Project Title: Clinical Trial Management System Software

I . Identification of the agency and contracting activity

DHHS, NIH, NIAID/OD/OSMO/OCICB

Requestors name: Amy Kent Requestors phone number: 240.669‐2771 Requestors email address: kentamy@niaid.nih.gov Address of the requesting lab/office: Bethesda, MD

II. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value) A. Type of action: (check the appropriate box):

☐ New requirement

☒ Follow‐on

Name of the previous contractor(s): Clinical DATAFAX Systems Inc

Sequence number, if available: 1670253

Was the initial and any subsequent awards competed? ☒ Yes ☐ No B. AMBIS Sequence number for this requirement: 1725057 C. Total estimated dollar value of the requirement (including options, if applicable): $43,250.00 D. Period of performance, inclusive of options: 05/01/2015 – 04/30/2016 E. Project Background

This Clinical Trial Management System Software renewal is needed to support more than 60 clinical trials and studies at the International collaborative research protocols in Mali, Uganda, Cameroon, Thailand, Cambodia, China, India and USA. They will be conducting clinical trials at remote locations in some clinical sites that do not have reliable internet access and therefore need a system that can be used with older technology such as fax machines for putting paper Clinical Report Forms (CRFs) into a CTMS database but also has the flexibility to use Electronic Data Capture. The developer of this product is also the vendor and sole seller of the product. It is used by pharmaceutical companies and the NIH grantees in developing countries to manage clinical trials because it supports the legacy facsimile technology.

F. Description of Supplies/services to be purchased This software technology provides data links with antiquated technology in remote, international locations. These remote locations do not have internet access and this is the only way to transfer critical data to medical and research databases.

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE)

☒ 41 USC 253(c)(1) and FAR Pa r t 6 . 3 0 2 ‐1 : Only one responsible source ☐ FAR Pa r t 8 . 4 0 5 ‐6 : Federal Supply Schedule (FSS), limited competition

☐ An urgent and compelling need exists, and following the procedures would result in unacceptable delays

☒ Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or

☐ In the interest of economy and efficiency, the new work is a logical follow‐on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole‐source or limited‐sources procedures.

Important Note: The statutory authorities listed below will rarely ever be used in NIH. Before selecting one of these authorities, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

IV. Demonstration that the nature of the acquisition requires use of the authority cited

A. Name and address of the proposed contractor(s):

DF/Net Research, Inc Seattle, WA 98122

B. Describe why only the requested supply/service will meet the government’s needs This software renewal is critical to research. This Clinical Trial Management System software is the NIAID standard for providing critical data links to remote areas of the world and is the only way to transfer information to medical and research databases. This software is embedded into the IT infrastructure, research methodology, and provides a critical tool necessary for to meet mission requirements. Years of research/medical case files are built around this software, transferring this data into a new system would be a massive undertaking, putting this research data at potential risk of corruption or loss during this transfer. The only alternative would be to replace this software/system, transfer research data, and change office processes/protocols. These changes would be a massive undertaking/disruption that would adversely affect numerous international laboratory experiments and have the potential loss of years of critical data. In addition to the loss of data, from past corporate knowledge new software tends to have unattended consequences/compatibility issues. This potential risk to research data is too high in this situation to change software systems at this time. The program office and the Contracting Officer have determined that only one source and no other source will satisfy agency requirements.

C. Describe why only the proposed contractor is capable of providing the requested supply/service Software is proprietary and is not sold by any other company.

V. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

Price reasonableness determination will be included in the acquisition file.

VI. Certification

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support my request (for the requestor) and approval (for the CO) of is accurate and complete.

Official Name & Title Signature Date

Requestor Certification

DHHS, NIH, NIAID/OD/OSMO/OCICB

04/08/2015

Contracting Officer Approval

JULIENNE M. KEISER

SUPERVISOR PROCUREMENT ANALYST