Pharmacovigilance Cots Solution And Associated It Tender - 18542992

Procurement Summary

Country: USA

Summary: Pharmacovigilance Cots Solution And Associated It Support Services

Deadline: 12 Dec 2017

Posting Date: 23 Nov 2017

Other Information

Notice Type: Tender

TOT Ref.No.: 18542992

Document Ref. No.: FDA-SS-18-1182003

Competition: ICB

Financier: Self Financed

Purchaser Ownership: -

Tender Value: Refer Document

Purchaser's Detail

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Tender Details

This is a sources sought notice for information and acquisition planning purposes only. This is not a request for quote or proposal. This notice does not constitute a commitment by the government to issue an rfp, rfq, contract, or order. The government will not pay for any effort expended or any material provided in response to this announcement. Requests for a solicitation will not receive a response.
This sources sought is being issued by the food and drug administration (fda) for the implementation of a commercial-over-the-shelf (cots) pharmacovigilance software tool that will assist the office of surveillance and epidemiology (ose), office of business informatics (obi), and office of information technology management (oimt) collect and monitor adverse events and drug quality associated with pharmaceuticals and biologics. The cots product must provide the features and functionalities listed in rfi attachment no. 1 - faers requirement traceability matrix.
Submission instructions
interested companies must submit the following information:
1. A completed rfi attachment no 1 - pharmacovigilance cots tool requirements traceability matrix
2. Capability statement limited to 10 pages addressing at a minimum the following:
• what pharmacovigilance cots tool does your company recommend and why?
• are you an authorized reseller or authorized agent to service this cots tool?
• please describe and give examples of the analytics capabilities of the proposed cots solution. Please note, described features must be available in the cots product now not to be developed during the contract. Some example features may include
data mining safety reports describe specific algorithms
interactive data discovery and exploration tools
visual analytics and dashboards
signal management
external internet links to data sources like medline
ad hoc query screens
user built custom reports
• does your organization have a capability maturity model level iii or higher...

Documents

 Tender Notice