FAQ

Medical Writing is a skill in its own right. Trilogy’s medical writers provide a multifaceted service, from organising the writing itself to analysing the data and presenting the results using the best text, graphs and tables to really communicate the messages contained in the data. The messages need to be clear and concise: without well-presented interpretation of results, it doesn’t matter how good your trial was. Like the tip of an Iceberg, the documents are ultimately all you have to show and be assessed upon. Trilogy’s writers will make sure your documents tell the messages of the data clearly and quickly.

A specialist Medical Writer has the following skills to contribute to your writing projects:

• Assess which documents are required;
• Provide detailed knowledge of European, US and international pharmaceutical regulations;
• Analyse and present data to demonstrate clearly the main output of a study;
• Produce clear, concise and consistent documentation compliant with the needs of the regulations or questions of the authorities as appropriate;
• Determine and coordinate the necessary inputs from the clinical or marketing teams;
• Orchestrate an effective and efficient document review process;
• Guide the client’s clinical team to discuss challenging topics, in order to understand and identify the important messages;
• Proactive problem solving skills;
• Project management of document production to ensure on-time delivery.

All Trilogy’s Medical Writers are science graduates, with many biology masters degrees and PhDs. All our writers undergo ongoing training; both within Trilogy and as attendees of regular EMWA (European Medical Writers Association) conferences and workshops. Our writers have a wealth of experience of clinical development and medical writing. Our experience covers the full range of the different types of documents required and the different audiences for which they must be tailored, as well as all manner of therapeutic and development areas. Such wide experience means Trilogy can offer truly specialist writing. We are not just “writers” but also advisors on the whole process of regulatory documentation; we help you decide on what to say, how to say it and how best to present it to your audience.

Not in our experience. The interpretation of results and their presentation is a skill in its own right. Medical Writing is not a skill typically considered when choosing the best statistician, clinician or investigator – and the burden of undertaking it can be an unwanted distraction and bottleneck for the clinical team. The best documents are usually achieved when a specialist medical writer is involved – to coordinate the process of input, produce the documentation, and ensure its efficient and effective review.

Trilogy’s Lead Writer for your project will coordinate all aspects of input, production and review. A checklist of the required inputs, a skeleton document framework, and a ‘kick-off’ meeting are the beginning of document production, which can start even before the data are available to optimize timelines. The main part of document production follows and includes the analysis and distillation of meaning from your data. A managed review process, refined over many hundred projects, leads to fast, effective and efficient review – without excess burden or effort from the clinical specialists, but nonetheless challenging your experts to crystallise their main messages. Kick-off and review meetings are sometimes held at client’s premises, but often the wide geographical spread of the members of the clinical team demands “virtual team” working – based on telephone conferences, email and other communication. Our writers learn the skills necessary to coordinate such global teams as part of their training.

Trilogy is ready to help you assess any of your needs. Trilogy will provide you with check lists and project life cycle plans and then organise a strategy meeting to discuss with you what your documentation and timeline needs are. Based on the feedback and discussion we have with you, we will provide you with an assessment of your current needs and a strategy for moving forward. Don’t be afraid to ask us: Some of our clients are organisations which have grown out of developing a single compound and do not yet have the experience of either writing or submitting regulatory documents, and are not aware of all the documents needed. Even for established clients, the changing requirements of the regulatory authorities (e.g. demanding new types of documents for newly regulated areas, e.g. paediatrics, health economics, benefits statement etc.) can prove difficult to keep up with. Whether in the pre- or post-approval phase, it can be bewildering to decide exactly what forms of communication and which message in particular will work best for your therapy and reach your target audience most effectively.

Contact us with a brief description of your situation.

Trilogy’s main offices are in Frankfurt am Main (Germany), Cambridge (UK), and Durham (North Carolina, US), but our medical writers are accustomed to travelling around the globe and coordinating global “virtual teams” of diversely-located clinical development team members.

Contact us with a brief description of your situation.