This Government Contract opportunity was posted on September 26, 2005. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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A -- Statistical Analysis in Support of DPMC 's Clinical Trials

Awarded

N01DA-5-8855Federal

Submission Closed09/23/2005, 12:00:00 PM UTC

Contract Overview

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

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NAICS: 541720

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Virginia Department of Health

POSTED

2 days ago

DEADLINE

in about 20 hours

AI Contract Overview

This contract is a total small business set-aside intended to provide statistical services in support of clinical trials conducted by the Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMC) under the National Institute on Drug Abuse (NIDA). The services include biostatistical input for study design, preparation of statistical analysis plans, conducting statistical analyses including interim data, and preparing reports for regulatory submissions such as IND/NDA. Additional responsibilities involve designing subject randomization schedules, programming for ad hoc data analyses, offering statistical consultation, presenting study results, and reviewing and approving Case Report Forms. Clinical trials themselves are not part of this contract scope. The solicitation, identified by RFP No. N01DA-5-8855, targets qualified small business concerns under NAICS code 541710, with a size standard of 500 employees. NIDA anticipates awarding multiple contracts with a three-year base period and two one-year option periods. The RFP will be available electronically around late December 2004, with responses due by mid-February 2005. The procurement process uses a streamlined RFP format focused on essential elements such as work statements and evaluation criteria. The contract specialist for this opportunity is Diane M. Loeb, reachable via email or phone for inquiries. This announcement does not obligate the government to award a contract.

General Info

Small business set-aside contract for biostatistical services supporting NIDA clinical trial analysis.

Agency

N/A

Contract Value

$342,040

NAICS

541720 - Research and Development in the Social Sciences and Humanities

Place of Performance

WA, USA

Set-Aside

NONE

Awardee

AXIO RESEARCH LLC

Award Issued Date

09/23/2005, 12:00:00 AM UTC

Documents

No documents available

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Timeline

PhaseAwarded

PostedDec 7

Presolicitation

AwardedSep 23

Contract was awarded

Submission Closed

09/23/2005, 12:00:00 PM UTC

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Organization & Contact Information

AgencyN/A

Contacts2 people available

OfficeN/A

Organization / Agency

N/A

Office AddressN/A

Contacts

Craig D SagerContracting Officer, NIDA/NIH

contact@example.gov

+1 (555) 000-0000

Kenneth E GoodlingContracting Officer

contact@example.gov

+1 (555) 000-0000

Full Description

THIS REQUIREMENT IS A 100% TOTAL SMALL BUSINESS SET-ASIDE. The North American Industrial Classification System (NAICS) code identified for this requirement is 541710 with a size standard of 500 employees. The National Institute on Drug Abuse (NIDA) plans to solicit proposals from qualified small business concerns to provide statistical services in support of Phase 1, Phase 2, and/or Phase 3 clinical trials coordinated by the Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMC). This contract will: a) provide biostatistical input into the study design, b) prepare the statistical analysis plan, c) conduct statistical analysis of study results, including interim data, d) prepare statistical reports for IND/NDA submission, e) design and generate subject randomization schedules, f) perform additional programming in order to conduct ad hoc data analyses, g) provide statistical consultation and present study results in meetings and h) review and approve Case Report Forms (CRF). Clinical trials will not be carried out under this contract. NIDA anticipates that this solicitation will result in the award of multiple contracts. The contracts will have a three-year base period and include two 1-year option periods. RFP No. N01DA-5-8855 will be available electronically on or about December 27, 2004. You will access the RFP through the FedBizOpps (URL: http://www.fedbizopps.gov) or through the NIDA website: (URL: http://www.nida.nih.gov/RFP/RFPList.html). Please note that NIDA uses a streamlined RFP format, which includes only the Work Statement, Deliverables, Reporting Requirements, Special Requirements, Mandatory Qualifications, Technical Evaluation Criteria, and other necessary Proposal Preparation Instructions. All information required for the submission of a proposal is contained in or accessible through the streamlined RFP package. Response to the RFP will be due on or about February 18, 2005. This advertisement does not commit the Government to award a contract. See Notes 1 and 26.