We help you identify key opinion leaders, perform literature searches, and prepare reports for the status of the disease of interest. We will also interview and select doctors participating in the clinical trial, set up a DSMB (data safety monitoring board) if necessary, design and draft clinical trial protocols, write annual trial reports, and write final project reports for FDA submission.
We help you identify required deliverables during each stage of product development, provide format guidance to documentations, and prepare packages for submission to the regulatory authorities.
We help you write a variety of internal documents, as well as study reports and summaries for regulatory submissions.