Observational Studies
Observational studies play an important role in the clinical safety evaluation of pharmaceutical products. They provide important information about the safety profile of a drug in real-world settings and can complement information from randomized controlled trials (RCTs), which are often conducted in highly controlled settings.
In the context of clinical trials, observational studies serve a number of important purposes, including:
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Identifying potential research questions for future clinical trials. By observing trends and patterns in patient populations, researchers can identify areas of interest that may be worth exploring in more detail through interventional studies.
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These studies can also help generate hypotheses about potential interventions or treatments. For example, if an observational study suggests that a certain lifestyle factor is associated with a reduced risk of a particular disease, this could lead researchers to develop a hypothesis that a particular intervention or treatment may be effective in preventing or treating that disease.
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Observational studies can be used to assess the safety and feasibility of a particular intervention or treatment. By observing how patients respond to a particular intervention or treatment, researchers can gain insights into how it might be used in a clinical trial.
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The outcomes of Observational studies can provide data for comparison with the results of clinical trials. By gathering data on patients who have not been enrolled in a clinical trial, researchers can gain a better understanding of how the results of a trial might be generalized to the broader population.
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Types of Observational Studies We Support
With over 15+ years experience, our clinical team has helped several pharma and medical device companies to conduct the following types of observational studies to generate valuable information on safety and efficacy of drugs and devices:
- Case Reports and Case Series Study
- Cross-sectional (Prevalence Study) Study
- Ecological (Aggregate) Study
- Case Control Study
- Cohort Study (Prospective and Retrospective)
- Nested Case-Control Study
How We Can Help
Study Design & Medical Writing
Our expert team of medical writers can support in drafting the ideal study design and the appropriate study execution plan with all required documentation.
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Clinical Data Management
We can provide the right EDC solution along with our end-to-end clinical data management functional services to capture, clean and extract clean data sets for statistical analysis.
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Biostatistics and SAS Programming
We specialize in discovering Value from Clinical Trial Data using Advanced Statistical Programming Methods to make meaningful interpretations.
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