A medical writer is an essential part of any project team involved in developing a product to market and beyond. There is a need for high quality documents throughout this journey and an experienced medical writer is well qualified to help plan, organise, craft, and review these documents, following relevant regulations, guidelines, and processes, to meet strict deadlines. The medical writer will understand how to tailor key messages for a particular audience so that complex scientific data is presented in a clear and concise manner. For example, writing a Clinical Summary for an assessor at an Agency will require a more regulatory tone in comparison to writing about real‑world evidence in a manuscript read by a medical doctor. Writing for a layperson also requires a unique skillset to make information for patients easier to understand. The medical writer’s technical expertise is vital to meet specific formatting requirements, aided by using templates and style guide, to maintain consistency across a project. As an example, consistency minimises the variation in search terms when redacting a document in accordance with EMA’s Policy 0070. Furthermore, by having a keen eye for detail, medical writers pride themselves on the quality of the documents they author, helping to simplify review cycles, and speeding up the approval process.
Finding a suitable medical writer for your project is often a problem. If in-house medical writing resource has limited experience creating a specific document, limited time to dedicate to a project, or priorities dictate that their energy is focused on other documents (e.g. regulatory requirements, pharmacovigilance, or post-marketing), then outsourcing should be considered.
So how do you go about outsourcing? Contracting out the medical writing services for a project is a huge decision. Getting it right is important to ensure timelines are met, quality standards are maintained, and a happy, trusting relationship is developed between the writer and project team. Achieving this whilst balancing the budget is no mean feat!
Firstly, decide on what needs to be outsourced and the milestones within the product’s lifecycle. Following the team’s strategy for clinical development, documents such as the study protocol, investigator’s brochure, patient information sheet/informed consent form will be needed from an early stage. After each study is complete, a clinical study report, narratives, and lay summary are needed within a set time frame. Subsequently, the marketing approval process will require writing for the Common Technical Document, which includes many summary modules, and then responding to questions raised by the Authorities. Post-marketing activities may require further documents for Phase IV studies, safety reporting, and sharing information via publications. It is crucial to know when the resource is needed, but getting the medical writer (or medical writing vendor) involved as soon as possible is generally a good idea. This will help promote quality and consistency in the documentation from the start of the project.
When selecting a vendor – from a single freelance medical writer to a large Contract Research Organisation (CRO) – it is common to send a Request for Information (RFI) to potential contractors for details of their capabilities, capacity and experience. This can be a useful screening process. For example, it is critically important to understand vendor QC processes. It may also be important to the project team that the medical writer is based in a particular geographic location, has experience in a particular therapeutic area, or that the medical writer is familiar with anonymisation of clinical reports (as laid out in Policy 0070). The RFI may then be followed up with a Request for Proposal (RFP) to further understand how the task will be resourced and budgeted, and to understand any assumptions that have been made by the vendor in relation to the proposed scope of work.
Once a medical writing vendor is selected, contracting out a relatively straight forward piece of work (e.g. a clinical study report) is advisable to get an initial measure of performance and how well the medical writer works with the project team. Managing the vendor may involve regular meetings for progress updates, but the medical writer should be allowed to integrate into the team and provide their expertise and advice where possible. There will inevitably be requests for source materials (e.g. supporting literature, templates, style guide), which should be provided as quickly as possible so that the medical writer has adequate time and information to plan and meet their objective.
Following completion of the contracted work, it is good practice to evaluate the medical writer’s performance on the task. Holding a ‘lessons learned’ meeting with the project team and the medical writer can help improve company processes, address training needs, and eliminate difficulties for any future collaborations. Remember to highlight the positive feedback as well as any challenges faced! Key performance indicators can be useful to quantify how well the vendor performed. Assessing whether milestones were achieved, if the document was delivered within the agreed budget, and evaluating feedback from stakeholders (via a questionnaire) are some examples of how metrics can be used to assess whether to continue working with the vendor. However, caution should be applied as it is also important to understand the reasons why a document was late or required an out of scope charge before assigning any blame.
Choosing the right medical writer is a key decision when developing documents throughout a product’s lifecycle. Achieving this can not only add value in terms of quality and technical experience, but ultimately, can help accelerate document production to help reduce start-up and submission times, meet reporting requirements, and inform the public and scientific community.
Published 10th October, 2018
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