Information required for setting up Medical Writing Team.

[DR.BIPIN CHANDRA]

Can anybody give information on :
working Process flow model for medical writing.
how much time each article takes to write on average?
what is the number of articles / month that needs to be written by different sizes of clients.
how many Full Time employees per client for different sized clients and
What is the revenue potential for this offering?

[Dr G Venkatesh]

Hi. Very good question. I think you are a group-head sort of person in a CRO or pharma company.

Thanks to the management institutions as now-a-days systems and processes are becoming a compulsion for every activity in life. However, practically these models can just guide you in the work-flow but not in estimating the success of your project. I had a first-hand experience in this. So use all the time-equivalents and other scores to just speculate the output but not the success of projects. You can speculate the success if you are sure that your writers are masters of their tasks. (One small suggestion i can give here to develop mastery in any therapeutic area is to read atleast 100 similar articles before attempting to write one)

Categorize your task into business (correctly spelt??) writing (writing for the marketing products like leave-behinds, brochures and pamphlets) or for scientific publications.

Writing for scientific publications in journals is relatively easy because firstly, you can't play around with the data and secondly, there are some guidelines set for writing specific types of articles(ex: CONSORT, etc..). However, a few things still play a very crucial role in the success or failure of the publication. These include

1. Your choice of journal (Tier 1, Tier 2 etc)
2. The natur of study (How innovative the concept is ???, Are the results really path-breaking???, etc)
3. The experience of the writer in the particular therapeutic area
4. The relationship between the writer and the copy editors within the organization (It is very common to find comments like "pls remove the comma" and "capitalize" after recieving an article fro a copy-editor. Instaed of writing these comments, the copy-editor himself/herself can do that minimizing the number of round an article is subjected to QC)
5. The punctuality of the external authors in responding to the revisions made by internal authors and writers
4. The frequency of communication between the writer and the journal reviewers( and also editors)

Once you submit the articles to the journal, it is only the potential of the study that is going to decide if your task is successfully completed. After the recent break out of the merck-elsevier scandal, publishing houses will become more serious in accepting articles for publication in journals.

Templates (Shells) can be made and kept in advance right from the moment when a protocol is finalized. If you are starting very early from the finalization of protocol itself, u need to take care abut the ammendments that occur in due course of time. These shells generally cover everything except the results, conclusion, and to some extent, the introduction part. Once the database lock happens and a CSR is published, it is upto the medical or publication writer to complete the submission process for journals.

Generally pharma companies take 3-6 months for publication of clinical trials in scientific journals. Now-a-days publication of clinical trial results is being included by many pharma companies as the last milestone in the clinical trial program. However, for a medical writer, the time you send the article to the journal for the very first time can't be taken as the end of the process cbecause you never know whether the article will be accepted without any revisions of the content.

The flow can be summarized as
1. Using a data capture sheet to lock all requirements like the targeted journal, estimated timelines, et
2. Preparing the shell (at time of finalization of protocol)
3. Preparing the summary sheet (after the CSR is published) and send for approval by internal authors (3 days in general assuming CSR is published. Don't even attempt to start if CSR is not there.)
4. Preparing first draft ( generally 1 week)
5. Review of first draft by internal and then external authors(1-2 wks)
6. Preparing final draft and submission to journal (3 days)
7. Attending journal comments andd revision requests (2-3 days)
8. Expecting publication ( Depends on your luck!!!!!!!!!!!!!!)

On an average around 10-15 high quality articles can be expected from a very experienced writer per year. There are some writers who can write 50-60 also but as the rule goes the quality will suffer).

Hope this will help.

If you really want to go into employee equivalents, pls mention and i will try my best to help you out.

[DR.BIPIN CHANDRA]

Wow! You are awesome Sir!! No words to describe. Thanks a lot for such detailed information you have provided me. We are in the process of start up of CRO.I will incorporate your valuable inputs into my new business model. I think you must be Leader/Vertical Head of Medical writing with a vast experience in the field.
If you can provide me approximate FTE's per client on different sizes of requirement would be most useful to me. Thanks a lot for helping me out. With Best wishes- Dr.Bipin Chandra.

[Dr G Venkatesh]

Thanks for your reply. I will send u the metfod to calculate FTEs for different medical writing projects by tomorrow evening as i am engaged in a very imp work now. But u need to do the mathematics part of it. From my experience, there is one very important thing every boss of mine insisted upon. Don't use the word "SIR" in any corporate companies or communications. About me, I was earlier involved with setting up of a publication writing group for one of the pharma MNC.

[DR.BIPIN CHANDRA]

Thanks for the advice and help.

[Dr G Venkatesh]

Hi Dr Bipin,

The first and foremost thing we need to do before calculating FTEs is to list out the various deliverables. In general, a pharma company will approach a writing organization for primary publications like manuscripts from trial results, abstracts for poster presentation, abstracts for oral presentations and secondary publications like reviews, meta-analyses, short communications, hand-outs at conferences, abstract books, and case studies. To calculate the FTEs, we need to convert all deliverables into equivalents taking one key deliverable as standard. Generally it is the manuscript that is taken as standard. Remember that this entire process is hypothetical and is only to set timelines and rough estimations. In practice, 3 abstracts written for oral presentation in conferences will constitute 1 manuscript equivalent.

[Dr G Venkatesh]

So we now had every deliverable converted into manuscript equivalents. To summarize, 1 Manuscript Equivalent (lets call it ME) corresponds to 3 abstract for oral presentation, 2 abstracts for poster presentation, 5 short communications, 5 slide decks.

[Dr G Venkatesh]

There was a very good report which actually did research on medical writing (publication writing in precise)and you can see the number of FTEs required for each activity in diifferent set ups in this report. Pls find the document attached. Pls send me your e-mail id as some of the documents i want to share are very huge in size.

[DR.BIPIN CHANDRA]

Thanks for your valuable information for calculating FTE's and also for attached pdf. You can e-mail me at [e-mail] warm regards- Dr.Bipin

[sharmilaraopn]

may be you should contact [e-mail],

[DR.BIPIN CHANDRA]

Thanks very much.

[Lauren]

i am also wondering about the insurance liability for medical writing apart from the umbrella of CRO liability. Anyone have any experience with this, also freelance writer's insurance? Many thanks.