Trilogy Writing & Consulting GmbH – Frequently Asked Questions

Which type of documents does Trilogy write?

Trilogy writes any type of documentation needed for your clinical development programme:

See the Portfolio Overview for complete details.

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. We can recommend companies to publish and print your entire submission if needed.

Which therapeutic areas does Trilogy cover?

Trilogy covers the full range of therapeutic areas for which drugs are being developed. We have written hundreds of documents in the following therapeutic areas, and can bring the benefits of this extensive experience to your particular indication:

Please ask if you require further details regarding our experience in your particular area.

How much experience does Trilogy have?

Trilogy has extensive experience in preparing clinical documents and Common Technical Document (CTD) submissions. Regulatory documentation is our focus. Each dedicated team at Trilogy has more than 20 years of cumulative experience writing clinical documentation for the global pharmaceutical industry. We are equally at ease writing about pharmacokinetics and pharmacodynamics as we are writing reports of clinical efficacy and safety or epidemiology. In addition to our experience in conventional drug therapies and medical devices, we have experience in novel therapies including stem cells and other cell cultures, parasites, and gene therapy (mRNA) treatments.

How many documents has Trilogy written?

We have written hundreds of Clinical Study Reports (CSRs) for all phases of clinical development and most indications. We have planned and prepared dozens of Common Technical Document (CTD) submissions, from straightforward local variations to complex global submission dossiers for multiple indications.

What does a Trilogy dedicated team consist of?

Each Trilogy dedicated medical writing team consists of medical writers, 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.

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.

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

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

Which specific medical writing training can Trilogy provide?

Foundation Skills in Medical Writing:

Basic Skills for Medical Writers
Project Management: the Investigator's Brochure as a Case Study
Effective Use of Statistics in Medical Writing
Data Presentation for Clinical Research (Parts I and II)
Interpersonal Skills in Medical Writing
Interpretation and Presentation of Subgroup Analyses
Targeting your audience

Training for Specific Documents

Clinical Study Report Writing, Reviewing, and Quality Control
Medical Writing between Dossier Submission and Drug Approval
Interpretation and Presentation of Drug Safety Data
Introduction to the Paediatric Investigation Plan Application
Updating Safety Information: Writing PSURs and Annual Safety Reports

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

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

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. In many cases 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 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.

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.