FAQ

Trilogy’s Medical Writers and Philosophy

Why engage one of Trilogy’s Specialist Medical Writers?

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.

What skills does a specialist Medical Writer bring?

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.

What’s so special about Trilogy’s Medical Writers?

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.

Can’t my Documents be written by statisticians, clinicians or investigators?

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.

How will my clinical team contribute to producing and reviewing the documents?

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.

How do I assess exactly what I need?

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.

Where are Trilogy’s Medical Writers located?

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.

Documents

Which type of documents does Trilogy write?

Trilogy writes any type of documentation needed:

…either for your regulatory programmes, e.g.:

Briefing Books, CDP (Clinical Development Plan), CSP (Clinical Study Protocol), CSR (Clinical Study Report), CTD (Common Technical Document), CTR (Clinical Trial Report), DSUR (Development Safety Updated Report), IB (Investigator’s Brochure). ICF (Informed Consent Form), IMPD (Investigational Medicinal Product Dossier), IND (Investigational New Drug), PADER (Periodic Adverse Drug Experience Report), PI (Product Information), PIP (Paediatric Investigation Plan), PPP (Pregnancy Prevention Plan), PSP (Pediatric Study Plan), PSUR (Periodic Safety Update Report), REMS (Risk Evaluation and Mitigation Strategies), RMP (Risk Management Plan), SAP (Statistical Analysis Plan), SmPC (Summary of Product Characteristics), USPI (United States Prescribing Information).

…or in support of your other communications needs, e.g.:

Abstracts, manuscripts, posters and slides sets.

In which format does Trilogy prepare documents?

Trilogy prepares documents in English in Microsoft Office (e.g. Word, Excel, PowerPoint) and/or PDF formats – ready for inclusion in your submission dossier.

Experience

How Trilogy Works

What does a Trilogy dedicated team consist of?

Each Trilogy dedicated medical writing team consists of medical writing, project management and quality control – to ensure fast and optimal production of our client’s clinical documentation. Each team has a team leader who oversees each document and is the primary point of contact for the client.

Do Trilogy documents conform to ICH and GCP standards?

Yes. Our Clinical Study Reports (CSRs) comply with the International Conference on Harmonisation (ICH) E3 guidance and our Common Technical Document (CTD) submissions comply with the ICH M4 guidance. We have developed our documentation process to comply with Good Clinical Practice (GCP) and we apply the principles of GCP and Continuing Professional Development (CPD) in all our work.

Do Trilogy communications documents comply with the ABPI Code of Conduct?

Yes. We can ensure that all your scientific communications documentation comply not only with the ABPI Code, but also with any other relevant codes (e.g. EFPIA), as appropriate.

What does the client need to provide?

Our clients provide the relevant documentation and data needed to prepare the specific document being written. Our clients also provide review inputs on each draft produced and are responsible for ensuring that the medical content and messages concur with their company’s policies.

Which formats and style guides are used by Trilogy for document production?

We prepare all our documents according to style guides to ensure consistent writing, normally using standard Microsoft Office software (e.g. Word, Excel, PowerPoint etc.). The Trilogy style guide reflects our extensive understanding and experience of clinical documentation. If you prefer, we can of course use your company’s own style guides and/or templates.

Can I stipulate the use of my own style guide or document templates?

Yes. As requested, we can adopt your ready-made document templates and/or style guides, or can help you to develop your own internal house style.

Training

Which specific medical writing training can Trilogy provide?

Foundation Skills for Medical Writing
Preparing Specific Clinical Documents
Strategic Communication Skills

For further details on the medical writing training, please click on the corresponding items on the Training submenu.

Contact us to see how we can help with your training needs.

Where does Trilogy training take place?

We normally send our trainers to your company location to provide training directly to groups of employees.

Are the training courses provided by Trilogy suited to a programme of Continuing Professional Development (CPD)?

Trilogy trainers regularly create and conduct training courses tailored to your specific needs covering a broad range of clinical documents, including new requirements and changes in practices as appropriate for Continuing Professional Development (CPD).

Outsourcing

Could I outsource all my medical writing requirements to Trilogy?

Yes. Trilogy’s philosophy is to work proactively with our clients to manage and write their entire clinical documentation. By engaging us at an early stage, you can be sure of pro-active support in initiating the necessary documents, programmed availability and continuity of medical writers, and coordination of your clinical team right through the production and review process.

We start by writing the protocols of the earliest studies, and assist our clients in the writing of all ensuing study protocols and reports, culminating in the preparation of submission dossiers in the Common Technical Document (CTD) format. Often clients also like to benefit from our experience with their development programme by having us write the manuscripts and scientific communications based on the study reports we have prepared.

A dedicated writing team from Trilogy integrated within our client’s clinical development team ensures the highest standards, and a maximum of consistency and continuity. Our teams have acted as “glue” within development teams – by bringing together diverse functions of the clinical team via the documentation – and have acted as catalysts in distilling the relevant messages by constructively challenging the clinical team throughout the process. This can be a major advantage in unifying an outsourced clinical development team, especially when spanning diverse organisations and locations.

Getting Started

Can I afford professional medical writing services from Trilogy?

Attention to good documentation is a small price to pay to ensure the best chance of regulatory success for the product of your clinical development. No study is too small for a well-written protocol or study report.

We are happy to provide you with a cost estimate for your project, and normally expect to do this within a few days of receiving precise details of your requirements.

How do I kick the process off?

Please contact us to discuss your requirements. We are happy to provide you with a cost estimate and plan for your project, however big or small, within a few days of receiving precise details of your requirements.