Meet the Masters of Medical Writing
At Trilogy, medical writing is our passion. As specialists in regulatory documentation, we provide a service that is more than just writing. Our writers are integral parts of our clients’ teams: proactively planning, coordinating and writing their regulatory documents to meet timelines, with a readability that reduces the time for review and approval. We have been helping pharmaceutical companies and clinical research organizations of all sizes, worldwide, to streamline their documentation processes for more than 20 years – either as support on a one-off document or the entire clinical development program.
We provide our clients with a constructive advice on their projects: we guide our clients’ teams through the writing process and ask them the right questions in order to produce documents that communicate effectively. Our writers are trained to understand that our job is not to produce a data dump: it is to think about the data available and work with the team to pull out the messages and present them as clearly as possible, so that a reviewer can quickly find the information they are looking for and easily understand the story to be told. Our approach to writing clinical documentation ideally results in a minimum of clarifying questions from reviewers, speeding the process of review and ultimately leading to faster approval.
Trilogy currently has more than 60 writers, who are located in Europe and North America.
Trilogy specializes in writing all types of regulatory, safety and post-marketing documentation including:
- Regulatory submission documents: Clinical Development Plans (CDPs), briefing books, Clinical Study Protocols (CSPs), Clinical Study Reports (CSRs), lay summaries, subject safety narratives, Common Technical Document (CTD) clinical and nonclinical overviews and summaries (Modules 2.4 through 2.7), Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) for medical devices, Investigator’s Brochures (IBs), Informed Consent Forms (ICFs), Investigational Medicinal Product Dossiers (IMPDs), Investigational New Drug documents (INDs), the EU Paediatric Investigation Plans (PIPs), the US Pediatric Study Plans (PSPs), responses to authority questions, and preparations for EU explanations and FDA advisory committee meetings.
- Post marketing documents: Phase IV clinical trial documents, observational study documents, Health Technology Assessment (HTA) reports, health economics and patient registry related documents.
- Safety documents: Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Reports (PADERs), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), safety evaluation reports, addendum to Clinical Overviews (aCOs), Risk Evaluation and Mitigation Strategy (REMS) and Risk Management Plans (RMPs), including EU RMP Part VI.
- Scientific Communications documents: abstracts, publications for scientific journals, posters and slide sets for conferences.
Should you require any further information about Trilogy, or you would like to discuss your medical writing requirements, please contact us:
Trilogy Writing & Consulting GmbH
Phone: +49 69 138 2528-22
Trilogy Writing & Consulting Ltd
Phone: +44 1223 603570
Trilogy Writing & Consulting Inc.
Phone: +1 984 260 3630