In the fast-paced world of clinical research, effective medical writing plays a crucial role in taking a drug to market. And with clinical advancements occurring at an increasingly competitive rate, the demand for well-crafted and time-efficient clinical documentation is greater than ever.
However, allocating time and resources to clinical writing poses a significant challenge.
This is where outsourcing medical writing services can significantly transform the process. By leveraging the expertise of professional medical writers and clinical research organisations (CROs), pharmaceutical companies can streamline their research and development efforts.
In this guide, we explore the benefits of outsourcing medical writing, as well as key considerations. Read on to discover valuable insights and practical advice.
What is Clinical and Medical Writing Outsourcing?
Medical writing is a process that involves writing of various scientific documents, such as research-related documents and any documents that are necessary to meet regulatory requirements, and is a key part of any clinical project. Medical writing can begin as early as writing the clinical development plan in the pre-clinical phase, and continues to be key throughout many other stages of a study or project’s life cycle, up to the post-marketing phase.
What Documents Does Medical Writing Cover?
Medical writing covers a wide range of scientific and medical documents that are required all the way through a study’s lifecycle. Some examples of the types of documents that are included in medical writing are:
- ICH GCP compliant Clinical Study Reports (CSRs) Phases I to IV.
- CSR synopses for public disclosure.
- Rewriting or amalgamation of existing CSRs and electronic Common Technical Document (eCTD) formatting of CSRs.
- Development Safety Update Reports (DSURs).
- Patient Safety Narratives (for CSR inclusion).
- Study protocols, amendments, and administrative changes.
- Investigator Brochures (IBs).
- Investigational Medicinal Product Dossiers (IMPDs).
- Standalone quality checks.
Because of the high amount of accurate scientific documents that are required, medical writing outsourcing has become increasingly popular, as not only does it take pressure off the clinical team, but it also ensures a high-quality result due to the level of medical writing expertise from a professional provider.
The Benefits of Outsourcing Medical Writing
- Save on costs: A big benefit of hiring professional medical writers is that their expertise can ensure the writing process is well-managed and high-quality from the start, meaning less time is spent on it, and therefore saves on costs.
- Efficient collaboration: Once you find a team of medical writers that work well with your clinical team and workflow, you can enjoy the benefits of having your writers be integrated as part of the team. This will make communication and collaborative work flows much more efficient.
- Save on time: Working with professional medical writers will save your clinical team a lot of time. Their skill sets and expertise in writing result in necessary documents being produced faster and at the high standard needed for submission.
- Expertise and specialisation: Having writers work on multiple or all of the documents involved in a project allows writers to become familiar with the project and workflow over time. As they gain understanding of the dynamics and processes, they can contribute to establishing more efficient writing and communication practices.
- Consistency: Consistency and rapport within the team are additional benefits of retaining the same writers. By working together on multiple projects, writers accumulate knowledge and experience that contribute to maintaining consistency in the produced documents.
- Regulatory Compliance: Working with professional medical and clinical writers means that you can use their professional knowledge and expertise to make sure your clinical projects remain compliant with any required regulations from the start. This can save time and stop projects from falling behind, when documentation has to be edited to meet regulation requirements, after the initial submission.
The Key Considerations in Medical Writing Outsourcing
- Finding the right level of expertise: When it comes to medical writing outsourcing, it can be a challenge to find a team of professional medical writers, who have a lot of experience working effectively with clinical teams. Ensuring that the clinical teams have the supporting documents they need at the appropriate times is key, and shows the expertise of the medical writers.
- Finding medical writers who can adapt quickly: The medical writing providers need to meet the requirements of the clinical teams, adapting to the workflows and communication styles used, so that documents can be produced that effectively communicate the key points and help reviewers find the key information they need.
- Building long-term relationships: The ultimate objective of outsourcing your medical writing is to find a team of writers you can build long-term relationships with, and integrate them to be a key part of your clinical team.
The 4 Main Stages in Medical Writing Outsourcing
When it comes to outsourcing your medical writing to an external provider, there are 4 main stages to consider:
- Determine the most suitable tasks and optimal timing for outsourcing.
- Search for and choose a medical writing company.
- Effectively oversee the activities carried out by the service provider.
- Assess the performance of both your clinical team and the provider upon completion of the project.
When Should You Outsource Medical Writing?
When the team recognises the need for medical writing support, outsourcing should be initiated with a predetermined plan outlining the required documents and their timelines, document deadlines should not come as surprises, avoiding unnecessary stress on teams as they rush to allocate resources and time for document preparation.
It is beneficial to sit down with the clinical team and thoroughly review the clinical development plan, identifying which documents should be outsourced. This exercise should be repeated every 6–12 months, ensuring that medical writing providers are promptly informed of any shifts in the plan.
The early production of well-written documents in a clinical program enhances the quality of subsequent documents. Involving an experienced writer from the beginning guarantees that the rationale, strategies, and storyline of the planned development are skilfully crafted in the initial documents.
As the number of required documents in a clinical program multiplies rapidly, the early documents serve as essential resources for later texts and ideas. By investing in well-crafted early-stage documents, the time required for writing and reviewing subsequent documents is reduced. Therefore, it is advisable to involve medical writers earlier rather than later in the process.
Finding The Right Medical Writing Company
When searching for a medical writing service, it is crucial to ask the right questions. While numerous companies promise quality and timeliness, not all of them possess medical writing as a core competency, including medical writing as part of their comprehensive solutions for clients. Ask about their writers’ years of experience and the range of documents they have worked on, you’ll want to find a writing team who have a lot of experience and have worked across a large range of topics.
When talking to a potential medical writing company, be sure to provide them with the most accurate information that you can. This will help them to judge the scope of the project, from which they should be able to give you rough estimates of document timelines. It’s also worth asking if the company encourages direct access for writers to key team members, as this demonstrates an understanding of the benefits of integration with the clinical team.
By asking the right questions and providing accurate and realistic information, you can select a medical writing service that aligns with your clinical team’s needs and ensures a successful collaboration.
Managing Outsourced Medical Writing
Integrating writers into the team should be the long-term goal, as this helps to facilitate communication and makes collaboration more effective. However, it can be common for medical writers to be excluded from strategic meetings. If a medical writer is not involved in discussions about the study or project, they will lack an in-depth understanding of the decisions made. As a result, accurately communicating the implications of these decisions in their writing becomes challenging.
Experienced writers possess valuable knowledge of structuring information and presenting it effectively. They can guide you through the documentation process and ensure that well-written documents easily convey their intended points. This can help reviews of documents to become more efficient.
To avoid unnecessary costs and delays, make sure your medical writers receive all relevant information as soon as it becomes available. It is wasteful for a writer to invest time in a document only to have it revised due to new data or altered decisions. Regular team meetings should be conducted to discuss deliverable timelines, any changes in strategy, and new information that writers may require.
Evaluating Performance
Evaluating the performance of writers at the end of a project is crucial. This assessment should inform the decision of whether you should continue working with the same writer(s) for future projects. It is recommended to arrange a meeting with key clinical team members and the medical writers to gather everyone’s thoughts on the collaboration. Generating a list of what went well and areas for improvement from both sides can guide efforts to enhance future collaborations.
Listening to the feedback provided by the writer is essential, as it can shed light on how the team needs to work with and communicate effectively with the writers. Unclear information or mixed messages from various individuals can lead to writing projects spiralling out of control. Taking the writer’s feedback into account helps avoid such issues.
Conclusion
Outsourcing medical writing is popular for its cost-effectiveness, high-quality results, and alleviating pressure on clinical teams. To optimise the process, you should try to integrate writers into the clinical team, and involve them in strategic meetings, which will let you benefit from their expertise in structuring information.
Finding the right company requires asking appropriate questions and providing accurate information, which will allow the medical writing provider to judge the scope and needs of the project. Managing outsourced writing involves timely communication, regular team meetings, and evaluating performance for continuous improvement. By considering these factors and fostering collaboration, outsourcing can efficiently produce high-quality regulatory documents.
Looking For Professional Medical Writers?
Our medical writing services provide comprehensive support for accurate documentation throughout the clinical development process. Our dedicated team of medical writers ensures the delivery of precise and submission-ready documents that adhere to industry standards and regulatory requirements. With their extensive experience spanning various clinical therapeutic areas, our team covers all phases of global clinical development, from phase I to phase IV.
Get in touch with us today to see how our team of medical writing experts can help to boost the effectiveness and streamline your documentation process.
FAQ’s
Is Medical Writing In Demand?
The demand for medical writing services is increasing because utilising a professional medical writing service can be much more time and cost-efficient than having your internal clinical team do the documentation. Plus, with their expertise dedicated to medical writing, the quality of the documents they produce is high, while also being submission ready.
What Are The Benefits of Medical Writers?
One of the main benefits of using a medical writer is that it takes pressure off the clinical team, and means you should have submission ready documents when you need them. Medical writers can use their expertise to not only support the clinical team with relevant documentation, but also can help to develop your documentation process by identifying obstacles and suggesting solutions that will make communication and collaboration more efficient.