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The Degge Group ―
headed by
Judith K. Jones, MD,
PhD
― has a diverse team with expertise in:
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Pharmacoepidemiology and drug safety studies
-
Analyzing
medical record and claims databases worldwide
-
Planning and implementation of Risk Management programs
-
Pharmacovigilance
-
Pharmacoeconomic and outcomes research
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Regulatory advice of pre- and post-marketing safety
Expertise at The Degge Group
Degge's diverse group of dedicated professionals are able to
provide services in a number of areas relating to drug and medical
product safety, regulation and epidemiology. The Research, and
Regulatory /Legal Divisions at the Degge Group are staffed with highly
experienced epidemiologists, analysts, pharmacists, and researchers who
are committed to excellence.
Selected specific areas of expertise include:
- Consulting in regulatory pharmaceutical and other medical product
safety issues
- Analysis of Adverse Reactions Data from the FDA's AERs data, and
the World Health Organization (WHO)
- Regulatory Audits - SOP development, internal reviews,
benchmarking
- Design and conduct of epidemiologic studies (of drug risks or
disease natural history) in a number of large medical claims or
electronic databases in the US, Canada, UK and elsewhere
- Design and implementation of pharmaceutical risk management
efforts in collaboration with key partners, including LAMA (Louis A.
Morris & Associates) and Dendrite International
- Development of multi-media information for patients (e.g.,
KidzwithLeukemia CD-ROM)
- Protocol and CRF development - controlled and observational
clinical trials, registries, surveys
- Statistical and clinical data analysis - controlled and
observational clinical trials, medical claims databases, adverse
events, modeling and simulation
- Survey design - patient and physician questionnaires
- Literature analysis - systematic searches and evidence-based
evaluations
- Legal Affairs - medico-legal research and expert
testimony
The Degge Group, Ltd. - Consulting in
clinical drug safety, pharmacovigilance, and pharmacoepidemiology since
1988.
1616 North Fort Myer Drive, Suite 1430
Arlington, Virginia 22209 USA
Phone: (703) 276-0067 || Fax: (703) 276-0069
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