The demand for medical writing is constant, as sophisticated clinical documentation is required beginning with pre-clinical documentation all the way to post-trial marketing materials. Lately, the ever-evolving clinical market, niche product pipelines, and expensive patents have driven the outsourcing of specialized activities, like medical writing, throughout the industry.
Traditionally, this documentation would be produced in-house by teams with advanced medical background and regulatory experience. As biotech, pharma and medical device companies launch more highly specialized products, the call for transparency throughout all stages of clinical studies has never been stronger. As a result, there is a growing need for medical writing for clinical trial documents, safety updates, and marketing applications that comply with the increase in regulatory demands.
Outsourcing medical writing can help. Because complex documentation can be more efficiently and effectively produced by trained experts, outsourcing medical writers can result in greater clinical trial outcomes. Below, we explore the benefits of using dedicated medical writers.
Reduced Review & Approval Timelines
Experienced writers understand the time needed to craft documents from multiple sources and have access to the tools, template libraries and processes to do so within optimal timelines. Studies have found that documents produced by a medical writer require less reworking and exceed the standard work rate by 1.5 times [1]. The ability to write lean documents, that are by nature, easier to review, offers a streamlined approval process resulting in the accelerated start of clinical trials. In essence, throughout the clinical trial and regulatory process, quality documents written by dedicated often outsourced medical writers are less likely to be retracted, achieving cost savings from quicker review and approval timelines.
Resources & Knowledge Sharing
Dedicated medical writers are trained in the latest global requirements, making them ready to meet the requirements and formalities of regulatory bodies beyond the organization’s regional expertise. External medical writers act as an extension of the in-house clinical team, facilitating the knowledge transfer of guidelines, regulatory requirements, and preferred terminology. This provides resources and training to the organization’s staff and creates lasting value.
An outsourced medical writer has the capacity to bring with them an array of technical resources to be utilized in future studies. Close collaboration between outsourced and in-house staff creates a flexible workforce dynamic and that ensures the rapid submission of complete documents without having to consider additional staffing, recruitment, and training costs when the documents are requested. Long-term, skilled medical writers can meet Sponsor’s demands while building in-house knowledge in teams who prepare clinical and regulatory writing less frequently.
Diverse Experience & Exposure
An experienced medical writer has likely worked within a wide variety of organizational structures, overcoming industry specific challenges with proven strategies for each one. These diverse experiences regularly expose outsourced writers to clinical team of scientists, regulators, clinicians, and sales & marketing professionals – where they gather and manage critical information sharing and gain perspective on a variety of viewpoints. This exposure is hard to find within one small organization.
Having a clear understanding of each professional’s experience means they can objectively raise questions for clarity, better identify challenges, and collaborate across functional departments quickly to produce quality content at high speed. Where an in-house clinician could provide insight for just one specialty area, an experienced medical writer can produce investigator brochures, patient information sheets, clinical study reports (CSR) and protocols, and regulatory submissions with confidence. This pays off; a 2023 survey of regulators found that 87% of respondents agreed that established medical writing functions and rigorous document development processes and standards produced higher-quality submissions [2].
Process Oversight
The remit of a medical writer is evolving; to overcome the submission of documents containing potentially poor statistical reporting, they must be able to accurately summarize statistical findings and interpret the data. Their understanding of complex pharmacokinetic/pharmacodynamic data and ability to translate highly scientific documents is essential to produce understandable and transparent documents for submission.
At the outset of protocol development, an external medical writer will work collaboratively with the internal team and the sponsor to develop a suitable protocol for execution in the clinical setting. Once finalized, the writer will support the development of other essential documents needed to initiate a clinical study and will also develop a CSR when it ends.
Throughout this process, medical writers can also serve as a valuable reviewing resource, forming part of the quality management team and offering oversight and an outside perspective. Reviewing listings and tables for the generation of the CSR, the writer ensures that they clearly and concisely reflect the results of the trials. If involved throughout the complete clinical review process, a medical writer can provide candid feedback on process improvements and highlight potentially unanswered questions to prevent gaps in subsequent documents contributing to business efficiency.
Long-term Strategy
External medical writers skilled in document development of the complete clinical and regulatory processes can provide a valuable breadth of experience toward creative contributions and strategy. Experience across different technology, pharmaceutical, and medical device platforms allows for a broad perspective that can be difficult to achieve and costly to maintain for in-house teams. Their exposure to varied tasks and environments makes them valuable contributors to protocol design to ensure the trial generates the information needed to meet the trial objectives towards regulatory and marketing approval success.
Sources
[1] Purcell TJ. The application of metrics to determine the work rate for producing the first draft of the clinical study report: Case study. Drug Inf J. 2005;39:171-175.
[2] Lisa Chamberlain James, PhD (Cantab.) • Julia Cooper, PhD • Joan Affleck, MA, MBA • Brian Bass, MWC • Julia Forjanic Klapproth, PhD • Dylan Harris, PhD, MBA • Cathy Tyrrell, BSc • Amy Myers, MPH • Cyndi Carr, PhD • Karen L. Fink, BA • Angela Russell Winnier, PhD*. The value of medical writing in the regulatory environment. Regulatory Focus, 23 May 2023. https://www.raps.org/News-and-Articles/News-Articles/2023/5/The-value-of-medical-writing-in-the-regulatory-env#citation
About the Author
Anna Guildford, PhD
Anna Guildford is a Senior Consultant with KCR Consulting. With more than 22 years of industry experience, she is an expert in medical writing, scientific research, clinical study documentation, and an author for many academic and industry publications. She obtained a PhD in biomaterials and is passionate about using science to promote healthy aging and combat disease.