Understand the Published Literature. Inform Your Research Program
We conduct pharmacoepidemiology literature reviews to help you understand the published knowledge related to your research question. Our clients use our literature review reports to help them formulate drug development and post-approval strategies and to place potential safety signals into the appropriate context.
We customize literature reviews based to meet your needs. We have conducted literature reviews as part of our support for:
Regulatory submissions
Pharmacovigilance
Risk management plans
Our experience includes literature reviews to examine:
Burden-of-illness
Measures of disease frequency
Risk factors
Treatment patterns
Utilization and persistence
Drug safety
Populations at particular risk
Benefit-risk assessments
Effectiveness of treatment
As part of the literature review process, we perform meta-analyses when suitable data are found in the literature review.
Literature Reviews, Tailored to Meet Your Needs
We customize your literature reviews to match the level of complexity that you require. Three simplified levels are described below:
Restricted
Targeted
Comprehensive
Description
An overview of the literature in a particular area of interest using a restricted, agreed-upon number of articles
Critical review of the literature for a targeted topic of interest; review is exhaustive within a narrow scope
Comprehensive review of the literature in a particular disease area, drug, or drug class
Example
Brief disease backgrounder for use in planning clinical development programs
Incidence of adverse events among a patient population or those taking a certain drug
Review of all information (prevalence, symptoms, health care utilization, etc.) related to a certain illness
References
Primary references and/or review articles
Mainly primary references, with some review articles
Mainly primary references, some review articles
Typical Timelines*
1-2 Months
1-4 Months
4-9+ Months
*Timelines will vary due to the complexity of the medical condition, number of conditions or diseases, countries of interest, breadth of current literature, translation requirements, and other factors.
A Methodology You Can Depend On
We have a consistent process by which all literature searches are conducted in a scientifically rigorous and efficient manner. We collaborate with you to develop the study plan, which includes defining:
Specific objectives
Scope of the review (e.g., targeted, comprehensive)
Inclusion and exclusion criteria (e.g., geography, patient population)
Database and data sources (including both peer-reviewed journals and "gray" literature such as unpublished manuscripts)
Desirability of conducting a meta-analysis
Deliverables and timelines
Once the plan is defined, the literature search is conducted and the process fully documented. The reviewer systematically abstracts information from the included articles to capture key elements of the study. Findings are summarized in a final report.
