lundi 13 juillet 2020

Commonwealth Informatics Signs Consultation and Support Agreement with FDA

Par Rédaction , dans Communiqués , le 16 décembre 2016

Thursday, December 15th 2016 at 3:00pm UTC

Commonwealth to work with FDA to enhance use of analytic tools for
proactively and strategically managing safety during drug approval and
post market surveillance.

WALTHAM, Mass.–(BUSINESS WIRE)– Commonwealth Informatics, a leading provider of clinical and safety
analytics products and services, today announced that it signed a new
contract to support the use of advanced drug safety review tools at the FDA
Center for Drug Evaluation and Research (CDER)
and the Center
for Biologics Evaluation and Research (CBER)
. The focus of the
agreement is for Commonwealth to support the expansion of the use of the
analytic suite of tools to help FDA manage their drug and product safety
proactively and strategically in drug approval and post market

The long-term objective of the project is to build on CDER’s and CBER’s
present use of Oracle signal detection software and to expand its usage
strategically. The expansion includes providing CDER safety reviewers
with the ability to evaluate a wider spectrum of health information
sources including spontaneous reports, electronic health records,
clinical trials, product labeling, social media, biomedical citations,
search logs, and chemical and biologic data. An increased capacity for
supporting the modern regulatory review of medical products is an
objective of FDA’s 21st Century regulatory review processes.

The near-term focus of the contract is to carry out an upgrade to the
latest versions of the Empirica Suite tools the FDA is presently using
and to provide enhanced support to the CDER and CBER user community.
This support includes day-to-day on-site and remote training and
assistance for end users, data curation and enhancement of data content
and data feeds, support for related and add-on applications, and the
provision of Subject Matter Expert (SME) services in the use of the

“The Commonwealth team has both the technical expertise and domain
knowledge needed to collaborate closely and effectively with the FDA on
this project, » said Geoffrey Gordon, Commonwealth Informatics President.
“We look forward to working with FDA to help solve tactical challenges
and deliver on strategic objectives that will improve the way safety
data is analyzed.”

About Commonwealth
Commonwealth Informatics is a technology
and services company
with industry expertise in medical product safety and public health
surveillance. Pharmaceutical and biotechnology companies, government
agencies, and healthcare providers use Commonwealth’s products and
services to assemble relevant data and answer complex clinical and
safety analysis questions quickly and accurately. For more information,


Commonwealth Informatics
Sheila Rocchio, 617-710-5403

Source: Commonwealth Informatics

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