Finding Your Fit: The Best Approach to Outsourcing Medical Writing

Written by Jed MacKenzie

So, you’ve decided to outsource your medical writing needs - What approach will you take?

Some biotech companies choose to include medical writing in a full-service CRO package, others work with a selection of individual contractors, while many are now opting to work with specialist vendors.

However you decide to approach medical writing, the solution must align with your team's requirements, budget, and objectives. Let’s look at the pros and cons of some common options:

1. Full-service outsourcing

The FSO approach involves medical writing being included as part of a ‘full-service’ CRO package alongside general clinical development, site selection, patient recruitment, data management, etc. The CRO handles all clinical, regulatory, and scientific writing and submissions and has minimal input or guidance from the sponsor team.

Many large CROs include medical writing as part of their full-service clinical development services/package.

Why?

• It's easy to have one supplier manage all documents, submissions, and the entire MW process
• You can scale the medical writing project team as needed
• You'll have access to supporting services such as quality control (QC), publishing, and clinical trial disclosure

Why not?

• The individual medical writer's expertise may not always align with what is required
• Medical writing may not be a core function of the CRO leading to inconsistencies in key messages and data
• It's usually the most expensive option, due to the comprehensive nature of the services

2. Individual contractors

This option allows you to outsource individual projects/documents to independent contractors directly to fill specific needs as and when required. Usually, this is on an ad-hoc basis or when a certain expertise is required.

It usually involves freelance writers working directly with sponsors.

Why?

• It's often a more cost-effective approach than outsourcing entire processes to large CROs
• Sponsors can select individuals with the exact project-specific expertise they need
• Writers will be working on projects that they are passionate about and that suit their expertise, resulting in high-quality documents

Why not?

• Managing many different contractors can be challenging and result in a lack of consistency
• Relying solely on individual contractors does not provide the scalability needed to react to ever-changing requirements
• Sometimes it's difficult to guarantee the long-term availability and commitment of individual contractors

3. Functional Service Providers (specialist vendors)

Working on an FSP basis is the most flexible approach to outsourcing medical writing. Specific regulatory, clinical, and scientific functions are outsourced to one vendor while the sponsor retains control and management of other key clinical development functions. FSP partnerships provide sponsors with a reliable medical writing solution that can adapt to their needs.

This approach is often provided by specialist medical writing vendors.?

Why?

• It's a scalable and reliable medical writing solution that can adapt to the sponsor's needs, whether that's occasional projects or a consistent stream of work
• Access to a consistent team of writers who have the project-specific expertise required
• One vendor/point of contact for all medical writing and related functions (publishing, QC, CT disclosure)

Why not?

• A successful FSP partnership requires effective and frequent communication between the sponsor and vendor points of contact
• It may not make sense to partner with a service provider if your medical writing needs are minimal or you already have an in-house writer

Factors to consider

However you decide to approach outsourcing medical writing, your solution must satisfy both your short and long-term needs. Some key aspects to consider:

• Consistent access to medical writers as and when they are required
• Short-notice support to deal with unexpected needs
• Expertise in both the therapeutic area and the document
• A project team that works well on a personal level

Where does Morula Health come in?

We combine standardized processes and project delivery with a focus on individual medical writer expertise. Morula Health can provide the 'best of both worlds' when it comes to medical writing - here's what we provide:

• Global team of writers to scale with your needs
• Standardized processes and project management
• Writers who are assigned to projects based on project-specific expertise
• Low medical writer project turnover rate
• An abundance of writers who are passionate about your programs
• Strategic input from experienced writers
• A single point of contact for all medical writing activity

If you'd like to find out more about how we can provide a bespoke solution that fits your needs, please fill out our website contact form.