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.

Announcements

Degge is proud to be a Gold Sponsor of the 31st International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), occurring August 24-26, 2015, at the Hynes Convention Center in Boston, MA.

Visit us at Booth #7

Let us know if you would like to set up a meeting.

Degge's President, Dr. Judith K. Jones, delivered one of 3 keynote speeches: "Pharmacoepidemiology - The Next Thirty Years: From where have we come, and where are we going in the next 30 years." at this year's 30th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE) in Taipei, Taiwan
(October 24 - 27, 2014).  More Degge News >>

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
E: info@deggegroup.com
S: LinkedIn
O: Online Form

 Degge Crest



Services


REMS

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





Pharmacoepi

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





HEOR

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

PV

Pharmacovigilance

  • 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

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


OSG

Oversight Group Management

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


SBIR Grants

Government Grants





Legal

Regulatory Medical-Legal

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


Regulatory

Graduate Internship Program

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


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