Truck Stop Sushi
Ever go on a road-trip and stop for gas and think, “Wow I’m hungry. I think I’ll get this sushi out of the rest-stop vending machine”
Of course not! At least, I hope not.
While there is a value to one-stop shopping in certain settings, most discerning people make the extra effort to find the right place to purchase quality goods and services which are truly important to them. Like good sushi, good medical writing is crafted by those with expertise and a passion for it.
Pharmaceutical companies invest hundreds of millions of dollars to support a single clinical development program and recouping those investments depends upon a successful filing.
Enter medical writing.
Large CROs can supply many of the multifunctional resources necessary to assure complete execution of the clinical development process—site feasibility and study start-up, database development and maintenance, clinical research associate support, global regulatory support, data monitoring. The list goes on. While it may be tempting to one-stop shop the CRO for your document preparation, you should appreciate that maintaining an experienced top-notch writing team is not their priority. Furthermore, the costs for these lower-priority services are typically inflated and may be hidden within the myriad of line items in your service contract.
Don’t be fooled.
High-quality submission documents are a conduit to regulatory success. Your CSRs, patient narratives, and summary modules need to be developed as quickly and efficiently as possible and really need to shine. Why not use a vendor who excels in medical writing? Specialized firms attract career medical writers who have deep experience and skill in creating regulatory documents. They know how to manage cross-functional teams and set realistic timelines and decrease the burden on your internal resources while reducing the overall cost and time to submission. Leveraging writing expertise allows you to produce high quality, meticulously QC’d documents, that may ultimately go on to support multiple regulatory submissions and other business development activities.
The next time you are at the CRO vending machine, think again before adding medical writing to the list of one-stop services. While it may seem inexpensive and convenient, chances are you will end up regretting your choice and the consequences could be painful and costly. A little further down the road, a specialty medical writing vendor is waiting to serve you.
Virginia Kelly, MD
Acumen CMO and Founder