Services

Services

Medical Writing

The development and submission of medical writing in the context of clinical research nevertheless plays a critical role in the success or failure of new compounds and devices.  

The success of a clinical development program depends on the proper documentation of research plans and results, Whatever the Medical Writing and Document Publishing demands, RAY delivers the quality and timeliness required to ensure a project stays on track.

Our Medical Writers can assist at any point in the product development lifecycle across Phase I to Phase IV, following ICH guidelines and are compatible with similar regulatory requirements; Our Writers have extensive professional background, skills in most therapeutic areas and have experience in a wide array of documents of clinical study, regulatory submissions and other documents involving the study to provide expert support at every stage.

We provide medical writing services as part of the comprehensive clinical trial program or as a stand-alone service.

 

Our Medical Writing services include:

 

Regulatory Writing:

  • Protocols and protocol amendments.
  • Informed Consent Forms/Patient Information Leaflets.
  • Clinical study reports.
  • Investigator Brochures.
  • Clinical sections of common technical documents (CTDs).
  • 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, DSURs).
  • Clinical trial registry synopses.

Medical Communication: 

  • Manuscripts.
  • Abstracts, journal articles.
  • Posters.
  • Slide presentations.
  • Publication plans.