This Government Contract opportunity was posted on April 3, 2015. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Operations, Maintenance and Enhancements of the DataFit Data Validation Tool

Awarded

FDA-SSS-FY15-1145136Federal

Submission Closed04/20/2015, 05:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 518210

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about 22 hours ago

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AI Contract Overview

The DataFit Support Services contract, solicitation number FDA-SSS-FY15-1145136, provides the FDA's Center for Drug Evaluation and Research with a specialized dashboard-driven platform for data standards checking. This system allows for the assessment of data quality and validation of electronic clinical and non-clinical trial submission data to ensure compliance with CDISC, SDTM, and SEND standards. By utilizing a web interface, reviewers can select specific submissions or studies to generate conformance reports that summarize data quality. The primary value of the DataFit program is its ability to drastically reduce the time required for data review, condensing a process that typically takes days or weeks into just a few hours. This award notice, posted on September 15, 2015, falls under NAICS code 518210 and is managed by point of contact Steven Chang.

General Info

Agency

N/A

Contract Value

NAICS

518210 - Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services

Place of Performance

531 Playmouth Rd, Ste 508, PLYMOUTH, PA, 19462-1642, USA

Set-Aside

SBA

Awardee

PINNACLE 21, LLC

Award Issued Date

09/15/2015, 12:00:00 AM UTC

Documents

No documents available

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Uniform Contract Format

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Timeline

1 update

PhaseAwarded

PostedApr 3

special-notice

Justification (J&A)Sep 15

Justification & Approval published

AwardedSep 15

Contract was awarded

Submission Closed

04/20/2015, 05:00:00 PM UTC

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Organization & Contact Information

AgencyN/A

Contacts1 person available

OfficeN/A

Organization / Agency

N/A

Office AddressN/A

Contacts

Steven ChangContract Specialist

contact@example.gov

+1 (555) 000-0000

Full Description

The Food and Drug Administration (FDA) hereby issues a notice of intent in accordance with FAR 5.201. Pursuant to FAR 6.302-1, the FDA will sole source with Pinnacle 21, LLC., 531 Playmouth Rd, Ste 508, Plymouth, PA 19462-1642 for the operations, maintenance and enhancement of the DataFit program, FDA's data validation system. Pinnacle 21 is the only contractor able to meet the requirement of this procurement. The FDA intends to award a five (5) year Indefinite Delivery, Indefinite Quantity (IDIQ) contract to Pinnacle 21 for the Open CDISC Enterprise software license and operations, maintenance and enhancement of the DataFit program. Pinnacle 21 is the sole owner, seller and developer of the Open CDISC Enterprise software that performs the data validation for the DataFit program. DataFit validation of electronic clinical and non-clinical study submission data is a mission critical component of the FDA's JUMPSTART service. DataFit is the FDA platform for standards compliance and data-quality evaluation of electronic submission data. The DataFit custom installation version of Open CDISC Enterprise is the only system currently capable of meeting FDA's data fitness assessment needs. Pinnacle 21 is a CDISC technology partner which enables them to provide validation updates in sync with the CDISC standards. The NAICS code is 518210, Data Processing, Hosting, and Related Services. This notice is not a request for competitive quotes or proposal. No solicitation document is available and telephone requests will not be accepted. Respondents may submit information pertaining to their capabilities to perform the services required above within a timely manner to Steven Chang at Tzeleong.chang@ fda.hhs.gov, which may be considered by the agency. A determination to compete this procurement from the responses received shall be based upon the discretion of the Government. It is anticipated that an award will be issued the Pinnacle 21, LLC. approximately fifteen (15) days after the date of this notice unless, the Government determines another vendor has the capabilities of meeting this requirement. All responses to this notice of intent shall be received no later than noon Eastern Time (ET) on April 20, 2015 via email to Steven Chang at Tzeleong.chang@ fda.hhs.gov.