The Future of Visual Study Archives

Your EDC study has come to a close. All data has been finalized and the database has been locked, and now –it’s time to generate your study archive. How do you make sense of all that data visually? The last thing you or your data reviewers want to do is struggle to...

Tailored Exports: SAS xport format available with VISION

While XML exports and archives are the preferred format for FDA/CVM submission, the older SAS xport (XPT) format is still allowed by and is being used by some companies for their data submission. VISION™ has always provided XML format and and now it’s possible...

A Case for HTML Archives for FDA Submission

Currently FDA official submissions must be in XML or PDF format, with the preference being the submission of at least the XML format. The rationale for these is the need to have a document that will be readable and accessible in perpetuity. This is definitely an...

Tips from CVM to Streamline Submissions

WASHINGTON, D.C. – April 20, 2017 – Tips from CVM to Streamline Submissions At the recent SQA Conference, we had an opportunity to meet with numerous representatives of the FDA Center for Veterinary Medicine (CVM). We spoke at length about protocols for...

Improving Inter-Rater Reliability

  Challenge   When multiple raters will be used to assess the condition of a subject, it is important to improve inter-rater reliability, particularly if the raters are transglobal. The complexity of language barriers, nationality custom bias, and global locations...