Experienced and Effective Medical Writing at Your Disposal

Synteract’s medical writing group consists of Ph.D.s, M.D.s and other distinguished individuals with a wide range of solid clinical and therapeutic experience to ensure that your clinical program is well designed to meet its goals.

Whether it’s a first clinical protocol, a pivotal trial protocol or the associated documents such as the ICF, the investigator’s brochure, or a full IND/IDE, Synteract’s team brings the therapeutic, clinical, regulatory, and writing expertise needed to ensure the success of your project from the critical start-up and design phase to final regulatory submission.

We can provide you with full medical writing support at study (or program) completion. Whether it is preparing the clinical study report for one study, the ISS/ISE for multiple studies, or the NDA/sNDA, MAA, PMA,or 510K, our experts can help expedite the submission and approval process.

Medical writers at Synteract have extensive experience in other aspects of the clinical writing process, including manuscripts for all tier-level journals. Our staff strives to strike a balance between medical and marketing components when generating expert reports, posters and other related clinical trial development documents.

Medical Writing services include:

• Protocol / Informed Consent development
  
• Investigators Brochure development
  
• SOP development
  
• Clinical Study Reports
  
• Expert reports
  
• Abstracts, manuscripts, and posters
  
• Regulatory applications and submissions
  
• ISS/ISE
  
• NDA/sNDA , MAA, PMA, 510(k) preparation and submission