Before You Hire a Clinical Evaluation Consultant: Read This
Thinking of Hiring a Clinical Evaluation Consultant?
So it’s finally time to either start that new Clinical Evaluation Report (CER) project for Europe, or remediate your current documents based on Notified Body feedback… and you’re looking for some expertise.
The truth is that whether you’re a seasoned Regulatory professional, or have never drafted a CER you can benefit massively from the strategic use of consultants.
Consultants who are focused on clinical data and clinical evaluation have the luxury of seeing a lot of submissions through audits. They clearly have the necessary skills and have done this hundreds of times (that’s a hundred times more than the average manufacturer with smaller portfolios). You cannot leave your clinical evaluation to chance.
But there’s a catch.
If you want to tap into a wealth of hands-on CER experience and hire a writing team, you need to be sure they are going to deliver. There are lots of promises made by medical device consultants, and I hate to say it but plenty of writers don’t deliver.
Do You Even Need the Help?
Potentially no, but we find that almost all manufacturers we speak to could benefit from at least a short conversation about their documents. Here are a few of the most common reasons people seek out help.
You Received a ‘Clinical’ Non-Conformity on their Audit
Questions on your Clinical Evaluation Plan, mentions of insufficient clinical evidence, misaligned intended purpose, and improper data analysis are all common terms we see every day.
Most of the conversations I have each day are related to how a company has presented its clinical evidence in its CER, CEP, or literature review.
If this is you, reach out to several providers (you can contact us here for a free assessment) and have someone who’s read a lot of feedback look over your comments.
Your Team is Short of a ‘Qualified Clinical Reviewer’
Under EU MDR, your clinical documents need to be reviewed and signed by an unbiased party who has reviewed them. It generally can’t be the same person that has written all the other documents (sorry teams of one!), and they need what is ambiguously defined as ‘an acceptable amount of clinical experience’.
The best way to meet this requirement is to hire outside counsel. It eliminates any question of internal conflicts of interest, and an external writing team should be able to guarantee you that their review’s CV will stand up to Notified Body scrutiny. If the consultant or writer you are speaking to won’t guarantee this, run!
In the below section, we will go in-depth about how to assess your current clinical evaluation report document, to determine if minor corrections are necessary, or if you’ll need a bit more support.
Your Clinical Evaluation Templates are Out of Date
Your MDD (if your medical devices are marketed in Europe) template will not work anymore. Trust us on this one. Even if your clinical data is solid, your medical devices simply will not get approved if the reviewer can’t check all the latest EU MDR boxes. We have yet to see a previous MDD template sail through audits unscathed and don’t recommend you try.
There Aren’t Enough Clinical Evaluation Hours in the Day!
A medical device Clinical Evaluation Report is no simple task to draft, even if you have the time. Stack on other technical file documents, looming deadlines, more urgent responses to the FDA to handle… and things can get overwhelming quickly.
Sometimes, you just need someone you can trust to do the heavy lifting when it comes to analyzing clinical data (systematic literature review) and drafting your clinical evaluation report and related documents. Qualifications aside, if you can’t dedicate a solid (uninterrupted) month or two of efforts to your scientific literature, and clinical evaluations then we recommend you push internally to hire additional support.
In many cases with our own customers, we perform the EU MDR systematic literature review while they write and integrate it into their clinical evaluation report. A hybrid approach is worth exploring if bandwidth is your only concern.
Where To Find Your Clinical Evaluation Report Writer
As someone who hires a lot of medical device and pharma writers, I can tell you that sourcing top-tier talent you can trust (at prices you can afford) is not the easiest task. Fortunately, there are several places out there that improve your chances of picking a winning team.
Big Consulting – The Most Common Option
If budget is of no concern, most medical device companies find it easiest to go with one of the larger firms that offer not only medical writing but many other consulting services and CRO services. The pros are that most of the larger firms evaluate their teams well. The downsides include pricing well above market rate, high turnover (consultants leaving/coming during your projects), and long timelines to get things done. In our experience though, they do get the work done at a reasonable level which is why they’ve become so reputable over the years.
Hire a Freelancer
LinkedIn and platforms like Kolabtree are chock full of independent medical writers and ‘firms of one’ that handle all kinds of RA and medical writing work. The pros of working with a freelancer are that they normally have a lot of experience with different kinds of medical devices, and they can be much easier to negotiate fair pricing with. The downsides to individual freelancers are always capacity, track record, and continuity over time. A single person can be nimble to get going… but only if they don’t have other clients with pressing needs. There is also the risk of retirement, or illness, requiring you to start all over again in a year’s time with a different writer and lose continuity with your clinical data understanding.
The CiteMed Approach
You didn’t think I’d forget to mention our team, did you? Firms like CiteMedical are set up to offer industry-leading writing capabilities (100% success rate track record) in a small and nimble package that boasts the fastest timelines of any writing team out there. Our writers are dedicated and rigorously vetted into our processes. With a focus on clinical evaluation report writing, our deep experience has grown exponentially in recent years of EU MDR and IVDR implementation. All at pricing that doesn’t create any awkward silences at your next budget meeting.
But enough about the different kinds of writers, let’s get into exactly how to make your decision of who will meet your needs most effectively.
How to Evaluate a Clinical Evaluation Report Writer
Now that you’ve identified a few groups or individuals that might be a good fit. It’s time to put them through the gauntlet of assessing their capabilities.
Sometimes it really does feel like you have to put future clinical evaluation report writers through the wringer in order to separate the legitimate writers from those that merely have impressive CVs.
But don’t despair, as I mentioned we’ve hired a lot of writers over the years and I can tell you that there are a few key indicators you can pick up on to assess a good writer without having to try them out on a project.
Timelines
For us at CiteMed, timelines are a huge focus as the majority of our clients are short on it! What kind of commitment can the writer you’re interviewing make for a given device class if the answer is always “Well it depends”? From them, move along. We’ve found that the best writers are also the best at estimating workloads and deliverables.
Our team can look at a set of feedback, and give you a tight schedule (down to the week) with options to rush the work. Make sure that whoever you are considering can do the same.
Guarantees
Guarantees are not something you come across much in consulting let alone Regulatory Affairs, but we feel it’s prudent to ask candidates and firms. The goal here is to identify their level of confidence in the work and long-term commitment to you as a client.
We do offer guarantees of approval on the documents we draft, and will revise and remediate should there be errors (or changing reviewer preferences) as necessary until your clinical evaluation report is approved.
While you aren’t likely to find similar commitments like that from big firms, or freelancers, we still recommend asking. Their response will tell you a lot about their company, culture, and ultimately how they’ll treat your clinical data.
Pricing
We firmly believe that any freelancer or company conducting medical device writing and specifically clinical evaluation services should be able to quote very fixed and rigid budgets for your projects. If a potential writer offers us an endless range with their hourly rate, we almost always say goodbye. At this point (especially in the EU), the clinical evaluation report (CER) is becoming standardized among those writing a lot of them. Hours put in, and thus pricing should be relatively easy to quote for. Medical Device manufacturers need to be aware of the ambiguous and open-ended proposals.
Team
Everyone has different preferences here, but I’ll shed a little light on what the CiteMed team has found works the best. The less involved the better…up to a certain point. (NEED CLARIFICATION)
We find that if a single person is responsible for managing the project, responding to all emails, doing the writing, doing the QA, and signing the final documents the risk of things slipping through the cracks increases.
On the other hand, if there are multiple teams collaborating on the same project in silos, that can disrupt the work just as easily.
What works best is using 1-2 writers (for continuity) and then a Project Manager/Account rep to own the delivery of everything on time. Don’t be afraid to kick the tires on your PM as well. Do they send weekly updates like clockwork (we enforce this for ours), or do they make project status available via some other tool? Are they the ones on top of setting up meetings, getting signatures, etc.?
On a single Clinical evaluation report (CER) this is less important, but still worth looking into.
Medical Device Experience and Track Record
What about the writing team’s history, successes, and failures? We always check references diligently and want to work only with people who have a long track record of actually passing audits. Remember, it’s one thing to write a clinical evaluation, it’s another entirely to get one CE successfully through an audit and end up with a CE marking for your medical device.
Length of Current and Past Clinical Evaluation Writing Engagements
This one goes along with a track record, but it’s worth looking into (especially if interviewing a freelancer) the length of their writing engagements. Having many different writing jobs on a CV can be good from an experience perspective, but it can also point to a writer who has trouble finishing projects and prefers to move on to the next higher-paying gig.
How to Assess Your Current Clinical Evaluation Report (CER)
Grab a Checklist and Evaluate your Template
The MDCG 2020-13 Guidance is a great start for evaluating your templates. Some reading through EU MDR/IVDR can also get you a nice checklist in terms of your GSPR requirements, how your clinical benefits should be stated, patient safety requirements, etc. We offer a free one to our newsletter subscribers that you can download.
Sufficient Clinical Evidence (Including Scientific Literature)
The main question from the MDCG Guidance (2020-13) relating to Clinical Evaluation is:
Does the clinical data provide sufficient clinical evidence to:
- Demonstrate compliance with the relevant general safety and performance requirements? State Yes / No, and provide additional information if relevant
- Support the intended purpose, the claims, and the information in the IFU and SSCP? State Yes / No, and provide additional information if relevant
If you can answer yes with confidence to the above, then you should be OK. Don’t forget to make sure that your clinical evaluation plan details not only the collection and clinical data analysis that was performed but also describes how you plan to update this data in the future. In both documents, it’s prudent to outline both the clinical safety and clinical performance endpoints you are focusing on for the medical device.
Was Your Clinical Data Analysis Performed at a High Level?
It’s not enough to simply have a wealth of clinical data. You need to present your analysis and subsequent conclusions in a way so that a reviewer can fully understand your clinical data, your approach to understanding it, and of course, your ultimate conclusion as it pertains to the safety and performance of your device.
Do take extreme care in the analysis of your manufacturer’s clinical data (and other clinical literature). A good presentation can make the difference between approval and a stack of review questions.
In Conclusion, Get Started Today
Don’t delay in your search for a great writing team to support your medical devices. And once you find one, hang onto them for dear life! The CiteMed team is always available to take your questions, and you can book a call (or email) with me directly here anytime to get a proposal for your project or answer some of your questions.
