RWD allows a broader insight into how the patient population responds to a new product outside the tightly controlled boundaries of a clinical trial. While randomized controlled clinical trials will remain the gold standard for assessing the safety and efficacy of investigational new drugs, new legislation in countries across the world is now recommending that Real World Data (RWD) from actual patients is incorporated into drug development. It is now more important than ever to understand RWD, both in terms of how it is collected and how it can be used.
At WEP Clinical we provide bespoke, custom in-house tools to capture RWD. Our consultancy offering in this space will draw on our experience to help you understand the following:
What type of data can be captured
What tools and methods can be used to capture data
How to analyze RWD and draw meaningful conclusions
How to present RWD to regulatory review boards
How to navigate HIPAA regulations and handle confidential patient information