Real World Data

Collecting real world data (RWD) from patients outside of the clinical trial setting can provide valuable insights for Sponsors, regulators, key industry stakeholders and end users of promising new drugs

What is Real World Data & Evidence?


    Data relating to patient health status and/or the delivery of health care that is derived from multiple sources outside of typical clinical research settings, i.e. in a patient’s real-world setting.


    When compiled and analyzed, RWD becomes RWE. RWE allows us to derive scientific conclusions from collected RWD, and potentially use these conclusions to support regulatory decisions.

Why Collect RWD in EAPs?

Considerations for Data Collection in EAPs

The regulations for collecting and monitoring data vary from country to country.

It is important to assess the regulatory guidelines in each country in scope to determine whether or not certain data is allowed to be collected.

Clearly defining what the end use of the data will be will help ensure an appropriate and effective data collection plan is designed.

If submission ready data is desired, data must be:

  • Coded using CDISC/CDASH
  • Monitored
  • SAS formatted extraction

It is important to choose an EDC system that has been developed specifically to make data collection compliant and efficient.

This will ensure the integrity of your data and help align on all data goals, regulations, and data input expectations.

Types of Data We Can Collect

If you would like to chat with our team about your data collection needs or learn more about how we can support you with your data collection program, then please complete the form to the left or contact us at: