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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:
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Size and characteristics of your target population |
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Characteristics and patterns of disease severity and impact |
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Current treatment utilization patterns |
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Disease burden and prevalence |
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Economic assessments of drug profiles |
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Actual usage risks of existing products |
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Secular trends in disease and treatment |
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Safety assessments of the drug and the drug category |
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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:
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Toxicology studies |
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Clinical pharmacology studies |
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Mechanistic studies |
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Randomized trials |
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Large, simple, naturalistic trials |
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Case-control studies of specific events |
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Adverse event monitoring for signal detection |
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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:
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Writing the integrated safety summary |
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Identifying potential benefits and risk
to patients |
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Epidemiologic, economic and patient-reported outcomes |
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Evaluating physician, patient and pharmacist perspectives |
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Implementing Q-TWIST methodologies to statistically measure relative benefits |
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Conducting stated-preference studies/conjoint analyses to determine patient's risk-benefit trade-off acceptance |
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Evaluating labeling and education materials |
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Related Services
For your benefit, we offer a variety of services that complement our pharmacoepidemiology and risk management capabilities:
