Consulting in clinical drug safety, pharmacovigilance, and medical product epidemiology since 1988!

The Degge Group, Ltd.

Located just outside WASHINGTON DC, The Degge Group provides consulting services to the biopharmaceutical and medical products sector specializing in clinical drug safety, pharmacovigilance, medical product epidemiology, and risk management.

Degge's staff has contributed to the burgeoning fields of pharmacoepidemiology and pharmacovigilance for over two decades and has worked to enhance the understanding of drug safety, drug use, natural history of disease studies, risk evaluation and mitigation strategies (REMS), benefit-risk assessments, and pharmacoeconomic and outcomes research.

Degge will help you identify and analyze key data to meet your needs.


  • As of April 24, 2017, The Degge Group, Ltd. has become a member of PharmaLex GmbH (Friedrichsdorf, Germany), an international consortium of small companies similar to Degge but with different areas of scientific expertise and focus in the biopharma industry. We are pleased about joining PharmaLex’s group of companies. The impact of Degge’s joining PharmaLex will primarily be felt in our Research and Regulatory Consulting Divisions, which will be enhanced by additional PharmaLex expertise and services. Read More

  • Degge’s latest publication, Long-term risk of reproductive cancer among Vietnamese women using the quinacrine hydrochloride pellet system vs. intrauterine devices or tubal ligation for contraception appears in the current online version of The European Journal of Contraception & Reproductive Health Care (Volume 22, Issue 2). Authored by Degge President and CEO Judith K Jones, MD, PhD, FISPE, with co-authors Arlene Tave, MA (Degge), John Pezzullo, PhD (deceased) formerly of Georgetown University Department of Biomathematics and Biostatistics, Sharon Kardia, PhD of the University of Michigan School of Public Health, and Jack Lippes, MD of the State University of New York at Buffalo Department of Obstetrics and Gynecology, the article reports on a large retrospective cohort study in Vietnam that Degge helped design and independently analyzed. The study demonstrated that there was no excess long-term risk of reproductive tract cancers associated with use of the quinacrine hydrochloride pellet system of contraception. The print version of the publication will be available in late March or early April, 2017. For questions, please contact Arlene Tave at

  • Our recent publication: Intranasal Fluticasone Propionate Observational Cohort Safety Studies: Reviewing Evidence from Databases on Two Continents” was recently published with open access in Drugs – Real World Outcomes. Coauthors included Earl Goehring Jr, and Judith K Jones, MD, PhD, FISPE.

Contact Us

The Degge Group, Ltd.
9302 Lee Highway, Suite 700
Fairfax, VA 22031 USA
P: +1 (571) 490-8020
F: +1 (571) 490-8408
S: LinkedIn
O: Online Form

 Degge Crest



Risk Management /
Risk Evaluation &
Mitigation Strategies

  • Risk mapping in the Pre-clinical or
    IND phases
  • Scenarios for focused clinical development and labeling
  • Strategies for implementing risk management
  • Phase III/IV Planning - special trials, labeling, surveillance
  • Development and management of pregnancy, product, adverse event, and disease registries
  • Development and evaluation of stakeholder education materials including focus groups and surveys
  • Assessment of REMS effectiveness


Pharmacoepidemiology Research

  • Analyze incidence of adverse events in drug cohorts
  • Conduct case control studies
  • Identify risk factors
  • Assess natural history of disease
  • Calculate persistence, adherence, and compliance with therapy
  • Evaluate compliance with contraindications
  • Perform comprehensive literature reviews
  • Extensive experience with healthcare databases worldwide


Pharmacoeconomic and Outcomes Research

  • Analyze comparative cost of alternative therapies
  • Identify outcomes after interventions
  • Calculate persistence, adherence, and compliance with therapy 
  • Conduct burden of disease studies



  • Adverse Event analyses to evaluate signals (FAERS, WHO data)
  • AE analysis to evaluate Drug Safety Profiles
  • Comprehensive synthesis of pre- and post-marketing AE data
  • OTC switch safety data analysis and strategy
  • Hazard assessment for potential product recall
  • Causality assessment protocols

Regulatory Affairs - US and International

  • Regulatory safety expertise
  • Optimizing safety group functions
  • MedDRA coding strategies
  • Competitive and regulatory intelligence
  • Regulatory authority meeting preparation and facilitation
  • Strategic and tactical help in addressing adverse event issues
  • Assisting with FDA negotiations on labeling issues
  • Benefit-risk assessments


Oversight Group Management

  • Scientific Advisory Committees
  • Endpoint Committees
  • Independent Adjudication Panels
  • Independent Review Panels

SBIR Grants

Government Grants


Regulatory Medical-Legal

For scientific support in medico-legal affairs please contact Degge's Senior Legal Services Manager through our online form.


Graduate Internship Program

  • HEOR Graduate Students
  • Master of Public Health Students
  • Doctor of Pharmacy Students/Residents
  • Overseas Researchers and Students

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