Scientific and
Medical Writing

To convey your message to target audience in a clear, concise and impactful way can be a daunting task, especially through the written documents such as clinical study protocols for clinical sites, performance evaluation reports for notified bodies, and regulatory submissions for regulatory authorities. KSL CRO team with decades of scientific, medical, and regulatory writing experience in a wide variety of documents can provide you with help on e.g., the following documents: ​

Image by Christin Hume
  • Product development plan

  • Clinical study protocol and report, investigator brochures (IB)

  • Performance evaluation protocol (PEP), scientific validity report (SVR), analytical performance report (APR), clinical performance evaluation report (CPR), and performance evaluation report (PER)

  • Pre-Submissions to the FDA, meeting request and briefing documents

  • 510(k) submission documents

  • PMA submission documents