CeLFA™ is Coderant's proprietary Clinical Electronic Filing Application. This application serves as a central repository for gathering clinical research data and assists in electronic filings with the FDA. It systematically archives and formats all relevant data from the clinic for a compound's electronic submission with the appropriate regulatory authority.

How a customized CeLFA™ application can help your organization:

  • based on a template IND model where relevant information is collected in a manner most conducive to the FDA's current guidelines on GMP, GLP, GCP, and trial design
  • allows a client's regulatory team to draw upon variable data sets and subsets to access the most compelling and complete data
  • links both commercial and academic investigators to ensure that all relevant data such as patient history, dosage information, and adverse events are tracked and available for inspection

CeLFA™ was originally built to digitize the data that invariably accompanies M&A work within the biopharma arena. Since each company's clinical and regulatory strategy and compound properties are unique, this platform is designed to be highly customizable. At it's core, CeLFA™ tracks data in a format compliant with the FDA's current guidelines on electronic submissions, including electronic signatures and batch records.
         
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