Independent data safety monitoring board of flight analogs bed rest activities NASA requires the services of an independent assessment organization to provide safety oversight of test subjects…

Ended Purchase Order Awarded Last action

Contract number
NNJ10HC29P
Awardee
Awarding agency
Obligated
$73,460

Award facts

Opportunity
Contract value 100% obligated
$73,459.72 Current and potential, with all options
Completion date 100% complete
Current and potential, with all options
Set-aside
No set-aside
Competition
Competed under SAP · 3 offers Simplified Acquisition
Pricing
Firm Fixed Price
Place of performance
Princeton, NJ 08540, USA
Legislative mandates

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Other Administrative Action 4 -$22,567
Other Administrative Action 3 $0
Exercise an Option 2 $48,027
Other Administrative Action 1 $0
Original award $48,000

Description

As the agency reported it.

Independent data safety monitoring board of flight analogs bed rest activities NASA requires the services of an independent assessment organization to provide safety oversight of test subjects participating in the 6 degree head down tilt bed rest studies. The vendor shall establish a data safety monitoring board (DSMB) that shall support ethical and safe scientific conduct of individual research studies in order to maintain integrity if research enterprises sponsored by the JSC human research program (HRP) and approved by the NASA regulatory organization, committee for the protection of human subjects (CPHS). The vendor shall conduct independent analyses of HRP research using recognized and credentialed experts in designated disciplines for said evaluations. The vendor shall provide the following to NASA: data safety monitoring board (DSMB) fashioned after a national institutes of health (NIH) approach credentialed subject matter experts in designated fields knowledgeable of the practices and procedures in specific discipline areas of medicine or physiology, in biomedical ethics, patient/test subject advocacy, and in biostatistics demonstrated successful past performance with NASA collaborate with study investigators and NASA sponsors to ensure the scientific integrity and quality of research efforts. This shall include establishing study performance measurement criteria, defining mechanisms for collecting and reporting performance data, and creating remedial action plans. Conduct through audits of study procedures, documentation, and data to ensure compliance with all applicable regulations and guidelines, as required. Draft a written DSMB chart that outlines standard operating procedures including: DSMB meeting structure, schedule, and format; meeting materials preparation and distribution; board expertise reimbursement; data presentation format to the DSMB; method, alert thresholds, and timing of interim reviews of the DSMB

Quick answers

Who was awarded contract NNJ10HC29P?

NNJ10HC29P was awarded to Theradex Systems, Inc. by Johnson Space Center (National Aeronautics and Space Administration) on September 9, 2010.

How much is contract NNJ10HC29P worth?

The government has obligated $73,460 on NNJ10HC29P.

Was contract NNJ10HC29P competed?

The extent of competition for NNJ10HC29P was competed under sap. The government received 3 offers.

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