BA BE studies
Bio availability and Bio equivalence studies typically require rapid turnaround. Short studies have typically been the domain of paper trials due to the lengthy set up time and costs of traditional systems being impractical.
Those involved in BA/BE studies are currently finding themselves under pressure to adhere to new regulations and guidelines. This inevitably increases the volume and complexity of the paperwork required. Read more about the impact of regulations on BA-BE studies by following the link.
How CRFweb can help
CRFweb, can help with all of this. In terms of turnaround, a simple BA-BE study eCRF can be set up in as little as a day on our EDC platform. If needed we can offer patient reported outcomes, ePRO, and eDiary. Relevant reports, sample documents etc can be uploaded onto our eTMF (electronic trial master file) module. Critically for regulation and audit purposes, all activities have an audit trail.
A comprehensive range of standard reports are available and bespoke ones can be created if needed to facilitate swift and efficient hand over to your statistician.
Your BA BE study will be created on a system that is FDA compliant and to GCP (Good Clinical Practice) standards.