Document Redaction
  
Global Data Sharing initiatives in the recent past have pushed the Clinical Trial Disclosure scope ever wider to include sharing of redacted and anonymized documents and data.

EMA, EFPIA and PhARMA, as well as a growing base of stakeholders, continue to work to increase the breadth of what trial information is made available, responding to the evolving demand coming from public and private spheres alike.
    
Whether your organization is preparing a submission to the EMA or responding to an external party request, Xogene provides redaction support for a variety of clinical documents including Protocols, Statistical Analysis Plans, Clinical Study Reports, and Clinical Summaries.
  
 
 


Types of Redaction 

Third Party Requests: 
Fullfilment of your company's policy on request for redacted documents.
Access to Documents: 
Requests that come to your company through the EU Access to Documents policy via the EMA.
EU Submission:
Redaction as part of a request for marketing authorization in the EU.