Lifecycle Support Systematic Literature Reviews

Systematic Literature Reviews

Systematic literature reviews are conducted for a wide variety of purposes that support development through post market surveillance of a medication or device. At CTI, our team of experts frequently conduct literature reviews which provide the basis for drug development planning, clinical study design and have become a significant element of regulatory submissions, especially in rare diseases.

Phase I-II:

  • Establish prevalence
  • Describe natural history
  • Determine current standard of care
  • Develop appropriate clinical endpoints
  • Describe the unmet medical needs in rare diseases

Later stages of development and commercialization:

  • Evaluate product utilization
  • Conduct cost-effectiveness analysis
  • Determine value / pricing models

Our talented team can provide:

  • Strategic planning to reach your objectives
  • Work plan / Protocol development
  • Data identification / extraction
  • Meta-analysis
  • Cost-effectiveness analysis
  • Clinical and economic outcomes
  • Publications
  • Safety submissions

Case Study

Background: A biotech company is seeking approval for a new treatment for a rare disease.  The company is experiencing an evidence gap regarding the relationship between biomarker levels in adults with the rare disease and outcomes. The developer needs evidence to support their clinical trial endpoint (biomarker) with the FDA.

Ultimate Goal: To fill the evidence gap that lowering blood levels of the biomarker in individuals with the rare disease reduces the prevalence of symptoms.

A systematic literature review identified studies that linked the biomarker and symptoms.  The studies supported the position that effecting blood levels of the biomarker correlated to symptom reduction.  This evidence together with a review of the burden of illness of this rare disease made a compelling case for the new treatment.  The results of the systematic review and meta-analysis have been incorporated into a FDA submission, accepted by the FDA, presented at a conference and published in a manuscript.  

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