Electronic Informed Consent Capabilities/ e-consent platform Tender, USA - 106452766

Procurement Summary

Country : USA

Summary : Electronic Informed Consent Capabilities/ e-consent platform

Deadline : 03 Sep 2024

Other Information

Notice Type : Tender

TOT Ref.No.: 106452766

Document Ref. No. : NIH-SS-7003851

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

Description

Notice of Intent to Sole Source for Electronic Informed Consent Capabilities/ e-consent platform

NIH-SS- 7003851



The National Institutes of Health intends to award a Firm-Fixed-Price purchase order to Medrio Inc. 345 California ST. STE 325, San Francisco, California 94104-2658, for electronic informed consent capabilities e-consent platform. In accordance with FAR Part 6.302-1, the Contractor is the only known responsible source who can provide the instrument as no other source has been identified who can provide the requirement listed below.

Justification:

Medrio-s e-consent platform, allows for collection of multiple participant signatories at multiple sites, optimized workflows, user acceptance testing, and build specifications, and only the manufacturer can provide the follow on service or maintenance because of proprietary data. To fulfill its clinical research mission, eyeGENE® requires electronic informed consent capabilities to allow for re-consent of over 6, 400 existing eyeGENE® participants (eyeGENE Stage 1 reconsent). This is necessary for changes in response to technology advances (e.g. whole genome/exome sequencing and the possibility of secondary findings, etc.) and in staying compliant with NIH-s evolving stance on genetics and clinical consents.

Additional Supporting Facts:

The National Ophthalmic Disease Genotyping and Phenotyping Network (eyeGENE®) is a research venture created by the National Eye Institute (NEI), part of the National Institutes of Health (NIH). eyeGENE® aims to advance studies of eye diseases and their genetic causes by giving researchers access to DNA samples, clinical information, and patients looking to participate in research studies and clinical trials.

As of the December 31, 2015, eyeGENE® had accrued 6, 400 participants- clinical data and corresponding bio-samples. The original scope of consent that participants agreed to was to engage in studies of ‘eye disease-. This is ge...
Active Contract Opportunity
Notice ID : NIH-SS-7003851
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : NATIONAL INSTITUTES OF HEALTH
Office: NATIONAL INSTITUTES OF HEALTH OLAO
General Information
Contract Opportunity Type: Special Notice (Original)
All Dates/Times are: (UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA
Original Published Date: Aug 28, 2024 04:50 pm EDT
Original Response Date: Sep 03, 2024 09:00 am EDT
Inactive Policy: 15 days after response date
Original Inactive Date: Sep 18, 2024
Initiative: None

Classification
Original Set Aside:
Product Service Code: Q701 - SPECIALIZED MEDICAL SUPPORT
NAICS Code: 541990 - All Other Professional, Scientific, and Technical Services

Place of Performance: San Francisco, CA 94104 USA

Documents

 Tender Notice

Sole-Source-JA.pdf

SOW.pdf