An increasing number of research teams, including those in the biotech industry, are choosing to outsource their medical writing needs to external service providers. With this upward trend in outsourcing comes a rapid growth in the medical writing market, which is projected to grow at 10.46% CAGR by 2030.
Biotech companies now have more options than ever when it comes to choosing the right medical writing service provider for their needs. But more choice can mean more overwhelm in a fast-paced industry. So, how do you go about narrowing down your search?
We’ve created this guide to help you navigate your medical writing options and select the best provider for you.
Bespoke solutions
Every biotech team and program is unique. A one-size-fits-all approach to medical writing is therefore unlikely to yield the best quality documents.
Your chosen provider should invest time in understanding your program, science and specific needs in order to build a team with the experience and qualities you need.
Access to the best Medical Writers
Providing a truly bespoke service hinges heavily on having an expert team of Medical Writers on hand with a wide range of backgrounds. Your chosen service provider must be able to assign a team of Medical Writers with the therapeutic, document, and project-specific expertise required.
Beyond technical experience and capabilities, your medical writing team should integrate seamlessly into your organization to make the process run as smoothly as possible.
That means having direct contact with your Medical Writer(s), who are invested in your project and can provide strategic input as well as expert writing services. It’s important they operate as a partner, not just a vendor.
Growth and stability
When partnering with a medical writing service provider, you need to be able to put your full trust in them. It’s much easier to do that with a well-established, stable organization. Indicators of stability include operating successfully for a sustained period and maintaining a low turnover of staff and Medical Writers.
A stable medical writing team means a reduced risk and greater confidence in successful project delivery.
Proven track record
It possibly goes without saying that you should look for a medical writing service provider with a history of successful projects and satisfied clients. Reading case studies, testimonials, and client reviews can help you understand the provider’s track record in terms of project management, quality control, and the standard of medical writing.
Transparent processes
While your program and drug may be unique, the fundamentals of clinical and regulatory writing remain relatively consistent. Quality medical writing service providers should therefore have standard operating procedures for producing high-quality final draft documents, produced on time and within budget, that they’re happy to share with you.
This should include templates of key documents for more efficient delivery, as well as a clear schedule of communication to reduce time spent chasing updates.
Project management, quality control and publishing
While working with the right Medical Writers is essential, don’t underestimate the importance of the rest of the project team in providing a truly comprehensive medical writing service and ensuring documents are finalized and ready for submission on time.
Generally, service providers that assign a dedicated Project Manager and Quality Control Expert to your project are more likely to be able to keep track of the moving parts (such as timelines, budget and quality), and ensure on-time, high-quality delivery.
Flexibility and problem-solving
Transparent, standardized procedures allow you to move forward with a medical writing provider with clear expectations. But knowing that your provider is adept at solving problems and reacting with flexibility to challenges throughout your project allows you to have confidence, too.
Reading case studies and asking questions about your provider’s approach to clearing obstacles (such as short-notice projects or working with draft data) can put your mind at ease when it comes to your project’s delivery.
Ask the right questions
Use our cheat sheet of questions to ask prospective medical writing service providers to help you find the right fit.
Service provider
- Is there a minimum amount of work you expect us to provide?
- What is your staff turnover rate?
Medical Writers
- How long will it take to assign a Medical Writer and get started?
- Will you send us your proposed Medical Writer’s CV?
- Will the assigned Medical Writer have [your document] and/or [your therapy area] experience?
- Will the same Medical Writer be available to work on my project from start to finish?
- Can I work with the same Medical Writer on multiple projects?
- Can you scale up and assign multiple Medical Writers at short notice if needed?
- On average, how many years’ experience do your Medical Writers have?
Processes and procedures
- What is your typical lead time from initial inquiry to project kick-off?
- How do you handle projects coming in at short notice?
- How many rounds of review do you usually schedule for a project?
- Do you follow templates to create [your document]?
- How do you ensure projects are delivered on time and within budget?
- Which direct communication methods or channels are available to the Medical Writer during the project?
- What role does the Project Manager play?
- What is your approach to QC and Publishing?
- How would you mitigate the impact of unforeseen circumstances on project delivery?
While the choice of medical writing service providers can feel overwhelming, using benchmarks to measure the suitability of your options can make it easier to narrow down your options and find the right provider for your project.
Morula Health assigns a bespoke medical writing team to each project with a seamless process that biotechs can trust.
Want to discuss your medical writing needs with us? Get in touch with our team.
