When the research is complete and the data are analyzed, you still need to provide your research results to regulatory agencies in the form of well-written, accurate, scientific documents that also happen to meet specific technical specifications for submission. A lot of vendors offer “Medical Writing,” but ISI is one of the few providers to employ professional writers and editors who excel at scientific writing and know the best practices for technical requirements.

ISI offers experienced medical writers and editors to assist you with:

• Writing nonclinical and clinical submission documents suitable for your application type
• Developing style guides
• Developing your own document templates or customizing our own ISIWriter™ template contents
• Reviewing for quality issues
• Converting labels to Structured Product Labeling (SPL)
• Networking to find excellent resources to assist you with:
  • CMC writing and editing
  • Medical reviews
  • Data Management
  • Statistical planning and analyses

Early-development functional groups tend to forget the ultimate goal of conducting the research is to achieve an approvable application that meets both technical and scientific content requirements. In a best-case scenario, collaborating with ISI’s Medical Writing group early in your product development cycle will result in your ability to implement many process efficiencies for document management, resulting in greater speed to market.

Click on the image below to view a detailed chart describing how ISI's Medical Services fit into a typical Product Submission Cycle.