Observational Studies

Helping you to see the big picture.

Observational research can help us understand more about causal associations between treatments and outcomes and more about the world in general. These non-interventional studies have become valuable tools in health because they offer broad ways to answer real-world clinical research and product usage questions. However, they are notoriously challenging to implement.

Several study designs fall within this category of research including:

  • Cohort studies, including prospective patient registries
  • Case-control studies, including retrospective chart reviews; and
  • Database studies using electronic health records (EHR) or third-party databases

Our global team of pharmacoepidemiologists, pharmacovigilance, regulatory, and research operations advisors are able to:

  • Help you define the needs of your target audience(s) and to develop the best study design to meet your research objectives
  • Define the optimal regulatory authority and ethics committee submission strategies in each country or region
  • Implement a study management and resourcing model trained to collect the required data in the most efficient manner and to agreed-upon standards of quality

Case Study: Metabolic disease observational study

When a client needed support in a global observational study involving nearly 60,000 patients, Parexel combined its global infrastructure with localized support to accelerate start-up, meet recruitment goals early and reduce site management cost by 150%.

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