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A -- Registry of Angioplasty Registries

Active

NHLBI-HV-08-04Federal

Contract Overview

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

AI Contract Overview

The contract involves establishing a comprehensive registry that integrates patient-level data from existing and ongoing registries as well as clinical trials related to drug eluting stents (DESs) and bare metal stents (BMSs). This registry aims to evaluate long-term success rates and adverse events by continuously collecting and analyzing data from multiple sources. Key responsibilities include providing biostatistical support for study design, monitoring data collection and analysis, managing administrative and logistical functions, developing operational materials in collaboration with a Steering Committee and the NHLBI, and facilitating communication through meetings and report distribution. The registry will also ensure the maintenance of necessary hardware and software for efficient data processing, storage, and retrieval, and support dissemination efforts by overseeing publication and sharing of research findings. The contractor must demonstrate expertise in integrating and analyzing large clinical data sets from both registries and clinical trials, with capabilities to automate data form processing for efficient medical data management. Additional logistical duties involve coordinating travel arrangements for registry personnel and supporting committee activities. Compliance with Central Contractor Registration (CCR) certification is mandatory for award eligibility. The solicitation is designated as a Total Small Business Set-Aside, emphasizing the involvement of small businesses in delivering this specialized data registry service focused on angioplasty outcomes.

General Info

Establish a comprehensive stent data registry with analysis, biostatistics, logistics, and publication support.

Agency

N/A

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance

Not specified

Set-Aside

SBA

Documents

No documents available

Documents will appear here when they are available.

AI Contract Breakdown

Uniform Contract Format

No documents to break down

The breakdown needs solicitation documents. None were found from this contract's source.

Timeline

3 updates

PhaseSolicitation

PostedApr 4

Sources Sought

Type ChangedMay 22

Sources Sought → Solicitation

Type ChangedJul 26

Solicitation → Sources Sought

Notice updatedJul 26

Notice details unchanged. Attachments may have changed.

Notice updatedJul 26

Notice details unchanged. Attachments may have changed.

Notice updatedJul 26

Notice details unchanged. Attachments may have changed.

Type ChangedJul 26

Sources Sought → Solicitation

Type ChangedAug 24

Solicitation → Sources Sought

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Organization & Contact Information

AgencyN/A

Contacts2 people available

OfficeN/A

Organization / Agency

N/A

Office AddressN/A

Contacts

Tirene CrowellContract Specialist

contact@example.gov

+1 (555) 000-0000

Joanne F DeshlerContracting Officer

contact@example.gov

+1 (555) 000-0000

Full Description

The research proposed is for the establishment of a registry of data that shall be collected and analyzed from existing and on-going registries and clinical trials. The registry shall combine patient level data from high quality registries and clinical trial data sets of drug eluting stents (DESs) and bare metal stents (BMSs). Rates of long term success and of adverse events will be evaluated. Additional data shall be collected and utilized in analysis as participant registries continue to collect and transmit data to the Registry. The Registry shall: 1) provide biostatistical support for protocol development, including power and sample size calculations; 2) monitor collection and analysis of registry data; 3) provide administrative guidance, oversight, and support for the registry as a whole; 4) develop a manual of operations, registry forms and informed consent documents in collaboration with a Steering Committee and the NHLBI; 5) make travel arrangements and reimbursement for registry personnel; 6) coordinate, plan, make arrangements for, and participate in the Steering Committee meetings and its subcommittees; 7) prepare and distribute minutes of meetings; 8) establish and maintain the necessary hardware and software required to process, store and analyze registry data; 9) prepare and distribute periodic technical and statistical reports; 10) review, registry plans, procedures, activities, and data to ensure the scientific validity and clinical relevance of the registry; and 11) provide administrative and logistical support for publication and dissemination of findings. The Registry shall have experience in developing plans for analyzing large numbers of clinical measures from clinical trials and registry data sets. The Registry shall have experience integrating and analyzing data from different clinical trial and registry databases. The Registry shall provide adequate facilities available for receiving, processing, storing, and retrieving medical data efficiently, including the ability to automate the processing of data forms. PLEASE NOTE: In order to receive an award, contractor must be registered and have valid certification in the Central Contractor Registration (CCR) (http://www.ccr.gov).