Blog Single Image

Medical Writing Software

Blog Author Avatar

Jamie Harsevoort


Posted On:

October 30, 2022

Medical writing software is must-have; however, until now medical writers have had few good options. In particular, there has not been any software designed to efficiently cut down on the time required to produce regulatory documents.

Investigational new drugs require a lot of regulatory documents to be written for the submission package, and the process often takes multiple years. This process is not only slow, it is often hampered by inconsistencies between the writers and reviewers that all contribute to the final package.

What is the risk that medical writing software can address? Medical writing software not only makes the process more efficient, it can reduce the risk of errors or inconsistencies. A recent analysis found that 69% of Phase 3 protocols required 1 or more substantial amendments, with each amendment averaging a delay of 3 months and an increased cost of $535,0001. These delays are expensive, time consuming, and often avoidable.

Otium's Regulatory DocWriter™ is medical writing software targeted to both reduce the time required to create regulatory documents, and to reduce errors and inconsistencies.

Our customers are often writing documents for:

  • Phase 1-4 Studies
  • Bioequivalence Studies
  • Medical Device Documents

If you are a medical writer, consider setting up a trial to see how our medical writing software can improve your workflow.


  1. No End in Sight for Trial Complexity, CSDD Report Reveals (

Get started with a 30-day free trial

Start creating regulatory documents for your organization with Otium's 30-day free trial. No commitment.

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Free Trial Mockup