Real World Data
At WEP, we work closely with Sponsors to understand the opportunity for Real World Data collection within their access programs. We then build tailored data collection solutions, using our in-house EDC platform, to collect valuable data that can be used by the following groups:
Sponsors
Regulators
Key Stakeholders
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
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.
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
- Questionnaires
- Patient-generated data including in home-use settings
- Data gathered from sources, such as mobile devices