Evidence-based decision-making is critical in health care. Literature reviews help you understand the published evidence related to your research questions—whether the results will be used to inform your drug development and post-approval strategies or place a potential safety signal into the appropriate context. Literature reviews can be stand-alone projects such as a disease (including rare disease) or regulatory landscape analysis. Alternatively, they can be a component of other larger projects such as regulatory submissions (e.g. Orphan Drug Applications, Pediatric Investigation Plans, Environmental Risk Assessments), pharmacovigilance, and risk management plans. They help you understand:
- Burden-of-illness
- Natural history
- Measures of disease frequency
- Risk factors and comorbidities
- Clinical practice patterns
- Utilization and persistence
- Drug or device safety
- Effectiveness of treatment or procedure
- Populations at particular risk
- Benefit-risk assessments
Because literature reviews often serve as the foundation for follow-on research and are used for critical decision-making, it is imperative that they are done well and with scientific rigor. From defining objectives and preparing the search protocol to conducting the search and reviewing the results, our rigorous, quality-controlled processes consistently ensure high-quality, fully-documented, and reliable deliverables.
Literature Reviews, Tailored to Meet Your Regulatory Needs
Our customized literature reviews are designed to meet critical regulatory deliverable requirements. In addition, as part of the literature review process, we can perform meta-analyses when suitable data are found in the literature review. Three standard literature review levels offered include:
| Restricted | Targeted | Comprehensive | |
|---|---|---|---|
| Description | An overview of the literature in a particular area of interest using a restricted, agreed-upon number of articles. | Critical and exhaustive review of the literature for a targeted topic of interest. | Review of all 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, with some review articles |
| Typical Timelines* | 1-2 Months | 1-4 Months |
4-9+ Months |
*Timelines vary due to the number of conditions/disease, countries of interest, breadth of literature, translations requirements, etc.
