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?

  • REAL WORLD DATA (RWD)

    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.

  • REAL WORLD EVIDENCE (RWE)

    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.

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Why Collect RWD in EAPs?

  • Increase understanding of your drug and its value-effectiveness in existing and new patient populations
  • Inform future clinical study efforts by evaluating whether new outcomes are significant and warrant additional clinical trials
  • Increase awareness among key stakeholders who could be future advocates for and users of your drug
  • RWD can be used to support clinical trial data that is submitted to regulatory bodies for product approval

Considerations for Data Collection in EAPs

Regulations

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.

Goals for RWD Collection

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

EDC Platform

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.

Benefits of Collecting Data with WEP

In-House Capabilities

We handle the entire EDC build process with our in-house resources. This ensures a higher level of quality control, customization, and responsiveness to your specific needs throughout the development process.

Rapid Turnaround Time

Our EDC development process is extremely efficient, resulting in a build time of 6-8 weeks on average. This ensures that your program is up and running quickly, allowing you to gather valuable data and insights sooner.

Reduced Burden on Sites

Our data collection solution reduces the data entry burden on the site by using an intuitive eCRF design and a platform that supports integration of multiple trial activities into a single eDC tool.

Types of Data We Can Collect

  • Demographic patient information
  • Safety
  • Dosing information
  • Efficacy
  • Quality of life (QoL)
  • Patient Reported Outcomes (PROs)
  • Electronic health records (EHRs)
  • Claims and billing activities
  • Product and disease registries
  • Patient-generated data including in home-use settings
  • Questionnaires
  • Data gathered from other sources that can inform on health status, such as mobile devices

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:

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