At Trilogy, medical writing is our passion. As specialists in regulatory documentation, we provide a service that is more than just writing. We have been helping pharmaceutical companies of all sizes, worldwide, to streamline their documentation processes for over 20 years – ranging from support on one-off documents to the entire clinical development programme.

Trilogy writers are integral parts of our clients’ teams: proactively planning, coordinating and writing their regulatory documents to meet timelines. Our writers are trained to think about the data available and work with the client teams 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 regulatory documentation ideally results in a minimum of clarifying questions from reviewers, speeding the process of review and ultimately leading to faster approval.

Trilogy specializes in writing all types of regulatory documents required in the course of a clinical development programme.

Pre-submission documents:

• Clinical Development Plans (CDPs)
• Briefing Books
• Clinical Study Protocols (CSPs) and Informed Consent Forms (ICFs)
• Investigator’s Brochures (IBs)
• Investigational Medicinal Product Dossiers (IMPDs), Investigational New Drug documents (INDs)
• Clinical Study Reports (CSRs) and subject safety narratives
• Plain language documents, including Lay Summaries of Clinical Trial Results (LS), Plain Language Protocol Synopsis (PLPS) and Plain Language Summaries of Publications (PLSP)
• Paediatric Investigation Plans (PIPs), Pediatric Study Plans (PSPs)
• Development Safety Update Reports (DSURs)

Submission documents:

• Common Technical Document (CTD) clinical and nonclinical overviews and summaries (Modules 2.4 through 2.7), including ISS and ISE
• Risk Management Plans (RMPs), including EU RMP Part VI; Risk Evaluation and Mitigation Strategy (REMS)
• Assessment aids
• Clinical Evaluation Plans (CEPs), Clinical Investigation Plans (CIPs), Clinical Evaluation Reports (CERs) and Clinical Investigation Reports (CIRs) for medical devices

Post-submission documents:

• Responses to authority questions
• Slide presentations and supporting documents for Advisory Committee Hearings (US) and Oral Explanations (Europe)
• Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs)
• Health Technology Assessment (HTA) reports
• Post-marketing and observational study documents (e.g., CSPs, CSRs)

Trilogy currently has more than 80 writers in 8 countries worldwide – Germany, the UK, Ireland, Portugal, Italy, the US, Canada, and India. We have 3 physical offices:

• Germany/Head office: Falkensteiner Straße 77, 60322 Frankfurt am Main, Germany
• UK office: Platinum Building, St John’s Innovation Park, Cowley Road, Cambridge, CB4 0DS, UK
• US office: 200 Meredith Drive, Suite 201, Durham, NC 27713, US

Please, visit our website for additional information including short videos, which give an idea of the style and philosophy of Trilogy.