Regulatory, clinical, and technical support services

Ended Definitive Contract Awarded Last action

Contract number
W81XWH18C0178
Awardee
Awarding agency
Obligated
$16,901,515

Award facts

Opportunity
Contract value 80% obligated
  • $19,706,261.29 Current, with exercised options
  • $21,257,406.29 Potential, with all options
Completion date 100% complete
  • Current, with exercised options
  • Potential, with all options
Set-aside
No set-aside
Competition
Full and Open Competition · 7 offers Negotiated Proposal / Quote
Pricing
Cost Plus Fixed Fee
Place of performance
Frederick, MD 21702, USA

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Funding Only Action P00031 · Regulatory, clinical, and technical services necessary to facilitate full program coordination, management, policy development, execution, and oversight for… $250,000
Funding Only Action P00030 · Support services to include but not limited to all personnel, equipment, supplies, facilities, transportation, tools, materials, and supervision necessary to… $416,619
Additional Work (new agreement, FAR part 6 applies) P00029 $1,397,738
Funding Only Action P00028 $3,000
Exercise an Option P00027 $549,442
Funding Only Action P00026 $177,003
Funding Only Action P00025 · Regulatory, clinical, and technical support services related to FDA approvals $394,057
Funding Only Action P00024 $379,883
Funding Only Action P00023 -$106,282
Funding Only Action P00022 · Provides for regulatory, clinical, and technical services to support to develop and manage medical materiel to protect and sustain the warfighter $299,810
Funding Only Action P00021 · Incremental funding (option 2) for regulatory, clinical and technical support services for the US army medical materiel development activity. $120,000
Funding Only Action P00020 · Regulatory, technical and clinical support services for the US army medical research and development command $1,315,816
Exercise an Option P00019 $572,948
Funding Only Action P00018 · Regulatory, clinical and technical support services for the US army medical research and development command office of regulated activities $1,330,507
Supplemental Agreement for work within scope P00017 · Regulatory, technical and clinical support services for the US army medical research and development command office of regulated activities $0
Funding Only Action P00016 · Incremental funding for regulatory, clinical, and technical support services in support of the US army medical research and development command office of… $1,248,281
Supplemental Agreement for work within scope P00015 · Addition of one regulatory affairs scientist and one medical writer for regulatory, clinical and technical support services related to covid-19 efforts in… $151,301
Funding Only Action P00014 · Incremental funding for option period 1 (clin 1001) to provide for regulatory, clinical, and technical services to support to develop and manage medical… $336,523
Exercise an Option P00013 · Exercising option period 2 for regulatory, clinical and technical support services. $500,000
Funding Only Action P00012 · Incremental funding to provide for regulatory, clinical, and technical services to support to develop and manage medical materiel to protect and sustain the… $218,987
Funding Only Action P00011 · Provides for regulatory, clinical, and technical services to support to develop and manage medical materiel to protect and sustain the warfighter -$274,440
Funding Only Action P00010 · Incremental funding for regulatory, clinical and technical support services - option period 1 $10,000
Exercise an Option P00009 · Exercising option 1 in support of regulatory, clinical, and technical support services $2,285,196
Funding Only Action P00008 · Regulatory, clinical, and technical support services for the US army medical research and development command office of regulated activities. This… -$3,586
Funding Only Action P00007 $1,004,725
Funding Only Action P00006 · Incremental funding for regulatory, clinical and technical support services for the US army medical research and materiel command office of regulated… $1,839,153
Supplemental Agreement for work within scope P00005 · Regulatory, clinical, and technical support services to support the US army medical research and materiel command office of regulated activities modification to… $0
Funding Only Action P00004 · Incremental funding in support of regulatory, clinical and technical support services. $381,599
Other Administrative Action P00003 · This modification is to correct the dcaa auditor dodaac in dfars clause 252.232-7006. This contract is for regulatory, clinical and support services. $0
Funding Only Action P00002 · Incremental funding in support of regulatory, clinical and technical support services. $1,177,847
Supplemental Agreement for work within scope P00001 · Modification to remove biostatistics quality assurance and validation (biostatistics QA/validator) support from this requirement for regulatory, clinical, and… $0
Original award $925,388
Show all 32

About this award

Icon Government and Public Health Solutions, Inc. was awarded a $21.3 million cost-plus-fixed-fee definitive contract by the Defense Health Agency's Medical Command on September 24, 2018, to provide regulatory, clinical, and technical support services to facilitate program coordination, management, policy development, execution, and oversight. The work is performed in Frederick, Maryland, with a completion date of November 30, 2021. This contract represents Icon's specialized expertise in supporting clinical research and medical countermeasure development, leveraging the company's extensive experience managing complex federal research initiatives across regulatory, clinical, and technical domains. No small business set-aside was utilized in this award.

The contract includes subcontract support from two specialized vendors: MPF Federal, LLC, a certified Economically Disadvantaged Women-Owned Small Business based in Gaithersburg, Maryland, providing senior regulatory affairs scientist services to manage Food and Drug Administration compliance and regulatory pathway development for drug, biologic, and medical device products; and Patricio Enterprises, Inc., a minority-owned, veteran-owned small business from Stafford, Virginia, supplying biostatistics support and submissions/publishing services. These subcontractors support the core mission of ensuring regulatory compliance, managing integrated product teams, and providing technical assistance for medical countermeasure development activities under the Army Surgeon General's medical research and materiel command programs.

Quick answers

Who was awarded contract W81XWH18C0178?

W81XWH18C0178 was awarded to Icon Government And Public Health Solutions, Inc. by Medical Command (Department of the Army) on September 24, 2018.

How much is contract W81XWH18C0178 worth?

The government has obligated $16,901,515 on W81XWH18C0178. Its current value, with exercised options, is $19,706,261. Its potential value, with all options, is $21,257,406.

Was contract W81XWH18C0178 competed?

The extent of competition for W81XWH18C0178 was full and open competition. The government received 7 offers.

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