Biostatistics for Real World Evidence

Unleash the power of Real-World Data to gain insights and help the market make better Data-Driven decisions

Real World Data

Real-World Evidence (RWE) is a critical source of information for pharmaceutical research because it provides a more complete and realistic view of how a product performs in the real world, compared to controlled clinical trials.

Based on data collected in the real world (RWD), this particularly important type of evidence provides meaningfull insight into how a product performs in the diverse, complex, and often unstructured environment of everyday medical practice.

One of the main benefits of RWE studies is to help confirm or extend the results of clinical trials: Clinical trials are carefully controlled studies that are designed to evaluate the safety and effectiveness of a product. However, the results of clinical trials may not always be representative of how a product will perform in the real world. By collecting Real World Data (RWD), researchers can confirm or extend the findings of clinical trials, and gain a better understanding of how a product performs in a wider range of patients and settings.

RWE also help to identify rare or unexpected side effects: Clinical trials are usually designed to detect common or expected side effects of a product. However, rare or unexpected side effects may only become apparent once a product is being used by a larger, more diverse population. Thanks to RWD, researchers get the opportunity to identify these rare or unexpected side effects, and take steps to mitigate any potential risks.

RWE supports treatment guidelines and policy decisions by providing evidence of how a product performs in the real world. This can help inform decisions about the most effective and efficient treatments, and guide the development of best practices for their use.

Finally, RWD supports the marketing and reimbursement of a product by demonstrating its real-world value and effectiveness. This is particularly important for new or innovative products that may not have extensive clinical trial data.

Regulators, payers, prescribers and patients are increasingly accepting the use of RWD, opening up a world of opportunity!


Siginifience’s Biostatisticians are committed to providing your team with full support in leveraging Real-World Data to take advantage of the opportunities RWE has to offer in drug development and commercialization.

  • RWE and Late Phase study design: We help you develop appropriate study designs, calculate sample sizes and develop statistical analysis plans. We also provide guidance on how to ensure the quality and integrity of the data being collected.


  • Real-world Data analysis: Our biostatisticians are committed to analyzing Real-World Data using appropriate statistical methods. We have extensive experience in different types of RWD from Pragmatic trials, Extension studies, Observational studies, Claims Databases, Patient Registries etc.


  • Impactful communication: We also provide critical support in interpreting and understanding the RWD generated. We play an important role in the challenge of communicating key information to regulators, payers, physicians and patients.