Medical Writing

Orbis Clinical’s medical writing practice provides our clients with experienced, knowledgeable professionals to properly address all facets of clinical and post marketed communication. Our understanding of the Drug Development Lifecycle, combined with a uniquely client-centered approach creates the foundation our people use to ultimately deliver the time-sensitive, quality regulatory and scientific documents our clients require for submitting to Global Regulatory Authorities.

Our engagement model provides our clients the flexibility to access experienced personnel, capable of addressing more tactical situations or teams of subject matter experts to develop and deliver your most critical writing projects.
 

Tactical or strategic, on-site or remote, time and materials or fixed price, Orbis Clinical will work with you to develop an approach that best fits your business model.

 

Investigational Drug

  • Applications
  • Investigational New Drug (IND) submissions
  • Standard Operating Procedures (SOP)
  • Investigator’s Brochures (IB)
  • Literature reviews and summaries
 

Clinical Development Phases I- III

  • Adverse/Serious Advers Event (AE/SAE) narratives
  • Developmental Safety Update
  • Reports (DSUR)
  • Protocols
  • Clinical Study Reports (CSR)
  • Regulatory reports
 

Approval Applications

  • New Drug Application (NDA) submissions
  • Medical Device (510k)
  • Risk-benefit analyses
  • Integrated Summary of Safety (ISS)
  • Integrated Summary of Efficacy (ISE)
  • Safety Updates
 

Post-Approval

  • Periodic Safety Update Reports (PSURs)
  • Periodic Adverse Drug Experience Reports (PADER)
  • Manuscripts
  • AE/SAE narratives
  • Regulatory reports advertising, labeling and promotions
 

To learn more about our services, contact us today!

Toll Free: 1-866-879-1963

Phone: 781-569-0607

Fax: 866-915-6480

Contact Us

 
 
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