All written up

 

To produce timely and thorough regulatory documents, publications and marketing material, Integrium offers the services of experienced medical writers up to PhD and MD level, on an as-needed basis or as part of a full trial workscope. The writing staff employs a meticulous approach to producing study protocols and documents that accurately present research findings, while complying with regulatory and ethical standards. They also understand clients’ marketing needs to clearly disseminate information to external and internal audiences.

 

Our medical writers offer a wealth of expertise in the following areas:

 

Regulatory Writing

• Briefing documents

• Clinical Study Reports

• Draft labeling

• Integrated summaries

• Investigator brochures and annual updates

• Medical Expert Reports

• Narratives

• Regulatory applications: IND, NDA, BLA, IDE, PMA

• Study manuals

• Study protocols

 

Marketing Writing

• Brief summaries of product information

• Drug monographs

• Literature reviews

• Manuscripts and abstracts

• Symposia materials

• Visual aids