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Pharmacoepidemi-ology and Risk Management
  > Patient Registries (Cohort Studies)
  > Database Studies
> Pharmaceutical Risk Management Overview
  > Pre-Approval Risk Assessment
  > Risk Minimization Program Development
  > Post-Marketing Evaluation

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RTI-HS HomeOur ServicesPharmacoepidemiology and Risk ManagementPharmaceutical Risk Management › Pre-Approval Risk Assessment

Pre-Approval Risk Assessment

Before a drug is launched, we can implement various research projects to help you better understand the potential risks associated with your drug. The FDA refers to this risk assessment as consisting of “identifying and characterizing the nature, frequency, and severity of risks associated with the use of a product.” Our team of safety experts, epidemiologists, outcomes researchers and biostatisticians can help you with a thorough risk assessment of your drug during the pre-marketing phase.

Disease Epidemiology
We conduct database studies, literature reviews and other research to evaluate the risk factors of a medical intervention, including analysis of:

Size and characteristics of your target population
Characteristics and patterns of disease severity and impact
Current treatment utilization patterns
Disease burden and prevalence
Economic assessments of drug profiles
Actual usage risks of existing products
Secular trends in disease and treatment
Safety assessments of the drug and the drug category

Risk Assessment from Clinical Trials
Our clinical development experts evaluate risks based on the review and synthesis of data from relevant studies and analysis of clinical trial data, including:

Toxicology studies
Clinical pharmacology studies
Mechanistic studies
Randomized trials
Large, simple, naturalistic trials
Case-control studies of specific events
Adverse event monitoring for signal detection

Risk-Benefit Analysis
By analyzing the data from the various sources listed above, our experts can provide insight and guidance regarding your drug’s risk-benefit balance. Our analyses can guide clinical trial design/protocol, regulatory submissions, label development and post-approval marketing strategies. We can also help reduce the cost of a potential risk minimization program by identifying, planning for and managing potential risks early on. A comprehensive risk-benefit assessment of your drug may include:

Writing the integrated safety summary
Identifying potential benefits and risk
to patients
Epidemiologic, economic and patient-reported outcomes
Evaluating physician, patient and pharmacist perspectives
Implementing Q-TWIST methodologies to statistically measure relative benefits
Conducting stated-preference studies/conjoint analyses to determine patient's risk-benefit trade-off acceptance
Evaluating labeling and education materials

 


 
SENIOR LEADERSHIP

  Elizabeth Andrews, PhD
VP, Pharmacoepidemiology and Risk Management
Wendy Painter, MD
VP, Safety and Pharmacovigilance
Susana Perez-Gutthann,
PhD, MD

VP and Global Head, Epidemiology
Kenneth Rothman, DrPH
VP, Epidemiology Research
Patricia Tennis, PhD
Senior Director, Epidemiology

For a full list of scientific staff bios, click here.

 
DOWNLOADS

 

Fact Sheets
- Therapeutic Risk
Management
- Pharmacoepidemiology
- Biostatistics
- Health Preference Assessment


Other
FDA's Guidance for Industry:
- Good Pharmaco-vigilance Practices and Pharmacoepidemiologic Assessment
- Establishing Pregnancy Exposure Registries
- Premarketing Risk Assessment
- Development and Use of Risk Minimization Action Plans

EMEA Guidance for Industry:
- Guideline on Risk Management Systems for Medicinal Products for Human Use
- Pharmacovigilance for Medicinal Products for
Human Use
- Template for EU Risk Management Plan


 
CONTACT US

 

To learn more about our research and consulting services, please call us at:

US: +1.800.262.3011
Canada: +1.613.742.8225
Spain: +34.93.241.7766
UK: +44(0)161.232.3400

Or email one of our experts directly.

 

 

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