Medical Writing

Medical Writing

Medical Writing is about communicating clinical and scientific data and information to a range of audiences in a wide variety of different formats. Medical writers combine their knowledge of science and their research skills with an understanding of how to present information and communicate it for the intended audience.

Medical writing is an essential and increasingly important activity required at every stage of developing a therapeutic product.

A clear, concise and professional presentation of study findings is an important factor in any development program. With a full complement of medical writing services, CliniExperts can provide all your documentation and writing needs. CliniExperts medical writing team has significant expertise in key therapeutic areas of pharmaceutical and biotechnology clinical development. They work directly with you to ensure consistency with your format and style while maintaining full compliance with regulatory requirements and International Conference on Harmonisation (ICH) guidelines. CliniExperts has a proven track record of timely delivery of quality medical writing deliverables coupled with outstanding customer service.

CliniExperts offers a comprehensive suite of medical writing services to support your clinical trial documentation needs from the early phases of development through post-approval. These services can be offered on a stand-alone basis or as an integrated part of a clinical trial, drug development program or medical information service.

CliniExperts medical writing services include clinical and regulatory writing like –

  • Protocols and protocol amendments
  • Informed Consent Forms/Patient Information Leaflets
  • Clinical study reports
  • Subject narratives
  • Investigator Brochures
  • Integrated summaries of safety/efficacy
  • Literature summaries
  • Clinical expert reports
  • INDs, NDAs, BLAs, CTAs (Module 2) summary documents
  • IND and NDA Annual reports
  • Safety Aggregate Reports (PSURs, PADERS, Line Listings, DSURs)

 

 

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