1) Documents you receive are not publishing-ready.
When final deliverables make it to your inbox, they should be packaged in a way that allows your team to simply upload the document into a publisher’s template.
At a glance, a publishing-ready document should include things like:
- Documents are saved in a proper format and are not password protected
- Documents have proper overall formatting, spacing and margin sizes
- Hyperlinks are active and correct
- Document uses recommended font style and size (e.g., Times New Roman size 10-12)
- All pages are numbered
- References are properly cited
2) You notice that feedback given is not properly reflected throughout the entire document.
Medical writing requires careful attention to detail and an understanding of the larger context of a project. When revisions are made to address specific concerns, but those changes do not carry through consistently in a document, it suggests a lack of thoroughness or a failure to grasp the overall narrative.
A medical writer should be deeply familiar with their deliverable and able to integrate feedback in a comprehensive way.
For example, perhaps you provide feedback to make an edit to one section in a document you are reviewing. An experienced medical writer should be able to take that feedback and apply it to all other sections in this document along with any other associated deliverables. For instance, perhaps a reviewer notes the error in a table within your Clinical Study Report (CSR). That same error may also appear in the CSR’s synopsis and conclusion, as well as within a Development Safety Update Report (DSUR) or Investigator’s Brochure on which the medical writer is working.
3) Small details are repeatedly falling through the cracks.
Your review time should be spent focused on the content and overall messaging – not fixing typos or inconsistent verb tenses.
If you notice a medical writing deliverable with a questionable number of grammatical errors, issues with punctuation, broken or incorrect links, or other quality-related issues impacting a documents professionalism or clarity, your vendor may have issues with their internal quality control process.
The best medical writers will deliver documents under the assumption that they are they final reviewer – catching the small details in editing or grammar before sending back to client.
4) You are functioning as a project manager when your medical writing vendor is failing to do so.
Your medical writer should be mindful of your project timelines and aware of how your deliverable fits in with your submission. A proficient medical writer should be aware of the impact of delays in availability of any references or feedback needed from the client on the progress of a deliverable and should be proactive in communicating any potential impact to the client.
A medical writer with strong project management skills should have a clear plan for your deliverable and should always have a contingency plan in place to avoid any delays to deliver the final publishing-ready deliverable with uncompromised quality.
Conclusion
A high-quality regulatory medical writing vendor should make your workload lighter – not add on another burden. If you are noticing signs like poor attention to detail, a failure to incorporate feedback across deliverables, or delays that the medical writer could have avoided, it may be time to consider a change.
At PharPoint Research, our medical writing team is committed to delivering precision, clarity, and consistency in every project within the timeline agreed upon. To learn more about our medical writing services or to request a quote for your project, reach out to our team.
