Home » Tenders » Americas » USA » Pharmacokinetic Analysis Resource Center Tender, USA - 99746108

Pharmacokinetic Analysis Resource Center Tender, USA - 99746108

HEALTH AND HUMAN SERVICES, DEPARTMENT OF has floated a tender for Pharmacokinetic Analysis Resource Center. The project location is USA and the tender is closing on 20 May 2024. The tender notice number is 75N95024R00078, while the TOT Ref Number is 99746108. Bidders can have further information about the Tender and can request the complete Tender document by Registering on the site.

Procurement Summary

Country : USA

Summary : Pharmacokinetic Analysis Resource Center

Deadline : 20 May 2024

Other Information

Notice Type : Tender

TOT Ref.No.: 99746108

Document Ref. No. : 75N95024R00078

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

Name :Login to see tender_details

Address : Login to see tender_details

Email : Login to see tender_details

Tender Details

Description

The National Institute on Drug Abuse (NIDA), and the Division of Therapeutics and Medical Consequences (DTMC), intend to solicit proposals as a SMALL BUSINESS SET-ASIDE using competitive procedures from qualified organizations certified as SMALL BUSINESS under NAICS Code 541715. The purpose of this requirement is to provide clinical research support services and pharmacokinetic resources in support of pharmacokinetic (PK)/pharmacodynamic (PD) studies. No actual clinical or laboratory studies will be carried out under the contract. The successful awardee shall:

Prepare study protocols; Monitor clinical studies to assure that pertinent FDA regulations are met; Perform data management for clinical and pharmacokinetic data; Perform statistical, PK and PK/PD analyses of experimental data obtained from clinical studies including clinical pharmacology and drug-drug interaction studies; Perform population pharmacokinetic (PK) and pharmacodynamic (PD) analysis for data obtained from clinical trials to investigate the relationships among dose, plasma concentration, and effect and; Prepare study reports. The data/reports will be submitted to the FDA in support of INDs (Investigational New Drugs) and NDAs (New Drug Applications); Provide support services which may include, but are not limited to, preparing progress reports, reviewing/revising protocols, consultation on design and data analysis, preparing PK/PD graphs and tables for presentations, performing literature search, as well as other support tasks; and Develop and maintain archival study records.NIDA anticipates the award of a single, five-year, indefinite delivery, indefinite quantity (IDIQ), task order contract. This award is a re-competition of 75N95019D00009, titled “Pharmacokinetic Analysis Resource Center.” NIDA may award either cost reimbursement and/or fixed price task orders under this contract. Individual Task Orders may include options to extend the period of performance and/or Options f...
Active Contract Opportunity Notice ID 75N95024R00078 Related Notice Department/Ind. Agency HEALTH AND HUMAN SERVICES, DEPARTMENT OF Sub-tier NATIONAL INSTITUTES OF HEALTH Office NATIONAL INSTITUTES OF HEALTH NIDA
General Information
Contract Opportunity Type: Presolicitation (Original)
All Dates/Times are: (UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA
Original Published Date: Apr 04, 2024 03:50 pm EDT
Original Response Date: May 20, 2024 01:00 pm EDT
Inactive Policy: 15 days after response date
Original Inactive Date: Jun 04, 2024
Initiative: None

Classification
Original Set Aside: Total Small Business Set-Aside (FAR 19.5)
Product Service Code: AN11 - Health R&D Services; Health care services; Basic Research
NAICS Code: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance: USA