As the popularity of outsourced medical writing continues to increase in the Life Sciences industry, partnering with the correct type of vendor is crucial for the successful and efficient development of submission-ready documents.
Clinical operations, regulatory affairs, clinical trial managers… the list of roles involved in the outsourcing of medical writing goes on. Many biotech and pharma companies have in-house medical writing teams that cover all bases; however, a growing number of companies are opting to outsource medical writing for different reasons. Some choose to rely on their full-service CRO to develop their documentation. Other, often emerging, biotechs find it more cost-effective to outsource their projects to individual consultants, rather than employing full-time writers. Both approaches have their positives, but this growing demand for outsourced services has led to the increasing popularity of specialist regulatory medical writing firms.
Whether it is a well-established pharma or an up-and-coming biotech, high-quality and timely regulatory documentation is vital for continued progress. Below, we delve deeper into different methods of outsourcing medical writing, and how the future of medical writing support could look…
Medical writing via a full-service CRO
Selecting a CRO is a critical part of many clinical teams’ drug development efforts. CROs offer many advantages, such as state-of-the-art research facilities, effective patient recruitment and retention, and extensive clinical resources. However, medical writing is sometimes overlooked by CROs, which can lead to delays or lower-quality documents. Additionally, the size of many CROs can result in a disconnect between the sponsor’s regulatory team and the CRO’s writers, leading to numerous, lengthy rounds of review. Open communication and collaboration between the teams could help to avoid these issues.
Independent medical writing consultant
In contrast to CRO medical writing, there are a growing number of independent medical writing consultants. Solo medical writers can be a viable option for biotechs with limited resources or those that only require support on a single, smaller project. However, the scope of work available is somewhat limited. These writers can only work on one document at a time and rarely offer quality control or project coordination services. A team of medical writers and project coordinators can provide more comprehensive support and relieve the sponsor’s team of the burden of organizing multiple individuals.
Why choose a specialist medical writing partner?
Alternatively, opting for a specialist medical writing partner can reduce delays and negates the need for a CRO to be selected before document development can begin. Given the breadth of medical writing projects, different therapy areas and global regulations, it can be difficult to find the perfect medical writer to fit the project’s needs. Partnering with a specialist medical writing firm means the most suitable medical writer can be assigned on a project-specific basis and multiple documents can be worked on in parallel. Ultimately, it is essential to carefully consider the benefits and potential limitations of each option in order to make the best decision for the progression of the clinical program.
Morula Health offers medical writing services that provide a balance between individual consultants and larger CROs. Our team has a wealth of experience and a variety of expertise. Each project is assigned a project coordinator, who facilitates frequent and effective communication. Additionally, our innovative software helps to ensure accuracy and consistency throughout the entire process. Whether you require one-off assistance or are considering a long-term, FSP-based partnership, Morula Health can support your regulatory medical writing needs.