Automation of study data tabulation model (sdtm) analysis data model (adam) / content validation (casa-CV)

Ended Awarded Last action

Contract number
75F40122F19005
Awardee
Awarding agency
Obligated
$257,920

Award facts

Contract value 100% obligated
$257,920.00 Current and potential, with all options
Completion date 100% complete
Current and potential, with all options
Set-aside
No set-aside
Competition
Not Competed Only One Source
Pricing
Firm Fixed Price
Place of performance
Penllyn, PA 19422, USA
Legislative mandates

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Other Administrative Action P00001 $0
Original award $257,920

About this award

Pinnacle 21, LLC was awarded a $257,920 firm fixed price delivery order by the Department of Health and Human Services' Food and Drug Administration to provide automation of Study Data Tabulation Model - Analysis Data Model content validation services. The delivery order was issued against an existing indefinite delivery contract held by Pinnacle 21 with the FDA, valued at up to $5 million, to support ongoing data systems operations and maintenance. Under this delivery order, Pinnacle 21 will utilize its OpenCDISC Enterprise cloud-based application to automate the content validation of clinical trial data submitted to the FDA using the Study Data Tabulation Model and Analysis Data Model standards. This will help maintain functionality of the FDA's regulatory review systems and ensure medical product safety. Performance will take place in Penllyn, Pennsylvania and be completed by September 2023. No set-aside provisions were specified.

Quick answers

Who was awarded contract 75F40122F19005?

75F40122F19005 was awarded to Pinnacle 21, LLC by Food and Drug Administration (Department of Health and Human Services) on June 23, 2022.

How much is contract 75F40122F19005 worth?

The government has obligated $257,920 on 75F40122F19005.

Is contract 75F40122F19005 an order under another contract?

Yes. 75F40122F19005 is a delivery order under 75F40121D00014, an indefinite delivery contract.

Was contract 75F40122F19005 competed?

The extent of competition for 75F40122F19005 was not competed.

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