Innovative Analytics
Experience, Customer Focus, Quality

Medical Writing

 
IA…. has done such a good job and knows our drug and PK study design well. So, at this point, we would like to transfer responsibility for the CSR to Innovative. Clearly, we have been very satisfied with all the work that Innovative has been doing for us, and we enjoy our working relationship. Kudos to you and the Innovative team for doing such a good job!
— Clinical Project Manager, mid-sized biopharmaceutical company

 
 

How we do medical writing at Innovative Analytics

IA medical writers are an expert source of knowledge on the scientific, regulatory, and industry requirements of the many types of documents that span clinical development, registration, and beyond.  They ensure that key messages are conveyed accurately, consistently, and clearly across all the documents in the clinical drug or device development and registration programs.

Our writers demonstrate an intense attention to detail with respect to scientific content, regulatory guidelines, specialized medical vocabulary, consistency in terminology, key concepts, and grammar and syntax.  They understand that attention to detail is a key component to the success of any document and remain steadfast in their quest to produce documents that meet the highest professional standards for quality. Our writers exhibit a commitment to teamwork, including flexible working practices and systems, that allow rapid response to client needs.

All IA produced documents are subject to rigorous control to provide assurance that they are produced in accordance with the protocol, statistical analysis plan (SAP), and regulatory guidelines, as appropriate.  The QC process verifies that the data collected during the study is completely, accurately, and consistently reported in the text, tables, figures, and data listings.  All QC is documented and available for audit or sponsor review.

 
medicalWriting_rotator.png
 
 
DSC09111_edited.jpg

Innovative Analytics works with you

A client had difficulty conveying key messages in their CSR.  IA rewrote the CSR with the client.

“I shared your…. report with some of our writers as I think it is a good example of how saying less can actually say much more.”

 
 
 

Overview of medical writing services

Innovative Analytics offers the following Medical Writing Services:

  • Protocols

  • Investigator Brochures

  • Investigational New Drug (IND) Applications)

  • ICH-compliant clinical study reports

  • Patient narratives

  • Briefing documents for regulatory meetings

  • Regulatory submissions in Common Technical Document (CTD) format, including:

    • Integrated Summary of Efficacy (ISE)

  • Integrated Summary of Safety (ISS)Safety Update Reports

  • Responses to regulatory agencies

  • Advisory Committee Brochures

  • Manuscripts

 
  Learn more about the IA Team.

Learn more about the IA Team.

 
 
 

we encourage you to Contact Innovative Analytics to request further information about how our Medical writing services can work for you.