Company insight
A guide for outsourcing medical writing for medical devices
Julia Forjanic Klapproth of Trilogy Writing & Consulting gives practical recommendations on how to optimise outsourcing with professional medical writers.
B
ringing a medical device to the market requires writing a medical device dossier for evaluation and approval by the authorities. With the increase in regulations specifying the content for these dossiers, more documents are now required throughout the device development program to ensure the appropriate information is collected and available for the clinical evaluation of each device.
This means medical writing activities are needed throughout a device development program. Ideally, they begin with writing the clinical investigation plan and continue through the many various study-related documents – from the investigator’s brochure to the clinical investigation report – culminating in writing the clinical evaluation plan (CEP) and report (CER). However, it can be a significant challenge to find professional medical writers who have the expertise to write these device-specific documents and to manage the outsourcing process. The job of outsourcing medical writing can be broken down into four main stages: 1. Identifying what and when is best to outsource
2. Finding and selecting the medical writing company
3. Managing the activities of the services provided
4. Evaluating performance at the end of the project.
The goal is to have a process that enables to select a provider who can help produce documents that communicate key messages effectively and help agency reviewers find the information they need. You also want to build a productive, long-term relationship with the service provider based on trust.
To assess this, consider the following:
■Does the company offer medical writing as a true expertise, or is it a tag-on function?
■Does the company make a recommendation for timelines? How detailed is it?
■Do they proactively ask questions about potential gaps in the provided material or point out any challenges they see in the request you have made?
Medical Device Developments /
www.nsmedicaldevices.com
or CER” is like asking the provider, “how long is a piece of string?”. Provide sufficient background information, clearly define each of the requested activities and be open to discuss any suggestions the writing company has about this. Key problems of the RFP process are a direct result of too little time for respondents to reply.
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Stage one: What and when to outsource?
The first step in outsourcing medical writing should be to plan the documents needed during the device program and when to outsource them. This is critical to avoid unnecessary time crunches when the documents are needed.
Stage two: Finding and selecting a medical writing company Many companies offer medical writing services, all promising quality documents that will be delivered on time. Yet for many, medical writing is not a core competency. For example, the core expertise of many contract research organisations (CROs) is the running of studies, data management and/or statistical analyses; not medical writing. Clearly then, the difficulty is finding which companies truly have the skill sets and experience to meet your medical writing needs.
■Do they recommend that their writers have direct access to your key team members?
■What is their process for dealing with team comments and how will they communicate open issues with the team?
Getting answers to these and other similar questions will give a fairly accurate idea of whether the provider is truly a specialist in the area of medical writing and will give more depth to the decision than basing it purely on cost. There are also things that can help the providers prepare the best possible cost proposal. When preparing the request for proposal (RFP), make sure to provide sufficient information and enough time to prepare the bids. Make it very clear what the expectations are for the project.
An RFP that simply defines the project as “the writing of the CEP
“An RFP that simply defines the project as “the writing of the CEP or CER” is like asking the provider, “how long is a piece of string?”. Provide sufficient background information and clearly define each of the requested activities.”
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